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Are you an outstanding Medical Director or ambitious Consultant Psychiatrist looking for new challenges, career development and a competitive salary?
We have an excellent full-time opportunity for a Medical Director & Consultant Psychiatrist to join us at Cygnet Hospital Beckton. This is our 58 bed gender specific hospital for women with complex mental health needs.
Cygnet Hospital Beckton is rated ‘Good’ by the Care Quality Commission (CQC) with inspectors praising staff for their ‘safe, person-centred care’.
Apart from being the Medical Director at Cygnet Hospital Beckton, you will also be the Responsible Clinician for New Dawn Ward - our 18 bed specialist Tier 4 Personality Disorder service for women.
Women can be admitted to New Dawn if they have a diagnosis of personality disorder, exhibit self-harming behaviour and are able to accept the need for help. Service users can be informal or detained under the Mental Health Act.
In this role, you’ll combine clinical expertise with sound strategic acumen and inspiring leadership to oversee the delivery of the very best care.
At Cygnet, our perks go way beyond pension schemes and excellent professional development.
You’ll also enjoy shopping, travel and leisure discounts – as well as a range of healthcare and financial benefits – to support you to be happy both in and out of work.
Apply now to enjoy excellent career prospects while reaping the rewards of making a difference to others – every day.
Your role responsibilities…
Why Cygnet? We’ll offer you…
We are looking for someone who is...
Successful candidates will be required to undergo an enhanced DBS check.
Cygnet has been providing a national network of high-quality specialist mental health services for more than 30 years. We have built a reputation for delivering pioneering services and outstanding outcomes. Our expert care enables thousands of individuals to consistently make a positive difference to their lives.
What next?
If you care about making a difference – we want to talk to you.
Click the link to apply of forward your CV to AlmaMatei@cygnethealth.co.uk
Proud member of the Disability Confident employer scheme
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Job Description
Associate Director, US Oncology Payer Marketing – Contract Execution
Our Market Access team monitors population demographics and develops solutions to ensure patients have access to our medicines. We work to ensure patient access through appropriately setting a contract strategy which helps support this objective. The Associate Director Market Access – Contract Execution will work closely with our payer marketing teams, IAM, Federal pricing, Commercial legal, Customer managers, and brand teams to define our contract strategy and execution for US Oncology Products. This role will report to the Director, Oncology Market Access-Contract Strategy but will support all US Oncology Products in contract execution therefore supporting all of the OCAR leadership team.
This specific opening is for an Associate Director US Oncology Payer Marketing - Execution with responsibilities for supporting all Welireg and new products contract strategy and execution. The selected individual will work with the Welireg Market Access Directors to set and execute our contract strategy. This role will be responsible for tactical execution and development of strategy, as well as collaborating with critical cross functional stakeholders (Organized Customer Access and Reimbursement, Marketing, Integrated Account Management Teams, Customer Managers, National Account Directors, Medical Affairs, etc.).
This role will focus on collaborating with brand marketing teams, agency partners and focus on various customer segments including payer and provider (e.g., health plans, Medicare, Medicaid, federal, pharmacy, hospital, Group Purchasing Organizations, etc.).
Primary Responsibilities
Work closely with our Company's internal functions (payer marketing, IAM, commercial legal, federal pricing, brand teams, etc.) to develop customer specific strategies and execute as appropriate to achieve access for patients and achieve business growth in a very dynamic and competitive landscape.
Develop comprehensive and innovative payer/market access strategies in alignment with the brand strategy and execute across relevant Company teams.
Provide input into the development of strategies, see through execution with cross functional stakeholders, monitor impact of implemented strategies, and continually iterate and evolve contracting strategies based on market dynamics/learnings and impact.
Work cross-functionally within our Company, including Organized Customer Access and Reimbursement, Market Research, policy team, Health Economics and Outcomes Research, compliance, legal, pricing and others to understand, communicate and execute Contract Strategy with customers.
Education Minimum Requirements
Required: BA/BS
Preferred: MBA
Required Experience and Skills
Minimum of (4-5) years combined experience in Pharmaceutical Marketing, Marketing Customer Management, Managed Care or Contracting
Minimum (2.5) years of experience leading contract strategy and/or execution
Demonstrated strategic thinking, problem solving, analytical critical thinking and planning skills.
Proactive nature and ability to manage change, anticipate risks, and design controls or mitigation.
Excellent leadership and communication skills (written & verbal).
Proficient at leading across diverse department and roles and effectively engaging senior management.
Strong judgment, prioritization, and decision - making skills, with understanding of broader context of corporate strategies.
Comfort and confidence in working with diverse teams and backgrounds; routinely demonstrates inclusive behaviors; actively seeks out diverse perspectives and experiences.
Demonstrated understanding of healthcare trends and policy issues around both pharmacy and medical benefits and their potential impact upon the company's business opportunities.
10% Travel
Preferred Experience and Skills
Associate Director level of Marketing or Managed Care/Payer Marketing experience/Contracting
Experience in Oncology/Oncology Payer/Oral and Infused
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/AOfficial account of Jobstore.
Job Description
Our marketing teams are passionate about bringing our medicines and vaccines to the world. Through digital listening and patient analytics, we are able to understand our customers’ needs and strive to provide solutions to meet them.
The Associate Director, US Pharma Payer Marketing, New Products/BD, is responsible for developing market access strategies and solutions for the assigned pipeline candidates and business development targets. The individual will collaborate across functions in the development of payer customer segment strategies, value evidence plans, and forecasts. In this role, the Associate Director will also collaborate with Global Market Access and Pricing teams in the development of pricing and contracting strategies.
The role will be responsible for Payer Marketing across various therapeutic areas aligned with business priorities. This position will report to the Director, US Pharma Payer Marketing, New Products/BD.
Primary Responsibilities Include:
Work closely with Global Marketing, Global Market Access, US New Products, and Business Development to provide a point of view on payer access for pipeline products and business development targets
Leverage market and customer insights to shape market access strategies
Develop payer customer segment strategy to inform forecast and choices regarding future products; support US Finance in the development of forecasts
Develop payer value propositions, pricing and contracting strategies
Active participation in the development of value evidence strategies; strong coordination with Outcomes Research / V&I (Value & Implementation Team)
Location: Upper Gwynedd PA, with Hybrid work model (3 days per week onsite) OR Remote with expectations of travel (up to 25%)
Education:
Required: BA/BS Degree
Preferred: Pharm D, MPH or other advanced degree
Required Experience and Skills:
Minimum of 5 years combined market access, marketing/sales leadership, account management, or consulting in the healthcare industry.
Demonstrated understanding of the mechanics and economics of the healthcare Ecosystem, including influences across various payer segments.
Demonstrated understanding of US healthcare trends and policy issues and their potential impact upon our company's business opportunities.
Demonstrated ability to develop and execute brand and customer marketing strategies to include innovative approaches and digital engagement.
Strong knowledge of marketing principles and activating market research insights.
Ability to translate market trends and customer needs into customer resources or tactics.
Ability to learn quickly and to assess a variety of scenarios, strategically and operationally.
Demonstrated strategic thinking, problem solving, analytical critical thinking.
Excellent leadership and communication skills
Demonstrated success in establishing, developing and maintaining business relationships.
Strong collaboration, project management and organizational skills; ability to prioritize activities and manage multiple tasks within deadlines.
Preferred Experience and Skills:
Experience developing market access and pricing / contracting strategies for pipeline products.
Product launch or launch planning.
Consulting/Stakeholder Management experience in cross-functional capacity.
Previous experience across a variety of therapeutic areas.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/AOfficial account of Jobstore.
Job Description
Job Summary
This position provides expert strategic, scientific and operational leadership to teams. In this position, you will have the opportunity to lead strategic operational initiatives, build talent across the organization, apply project management and organizational leadership expertise to a clinical development portfolio, including due diligence and integration activities, in our fast paced, industry-leading, dynamic bio-pharmaceutical company.
Core Responsibilities
Provides and manages operational and scientific strategy, design, and execution for multiple programs within a Therapeutic Area (TA).
Accountable for the communication of progress, status updates, mitigation plans and escalation of issues for trial or program level deliverables to Sr. Management.
Keeps abreast of pharmaceutical industry best practices, regulatory requirements and corporate strategies that impact the organization.
Responsible for ensuring operational and scientific consistency and quality development and execution across multiple clinical programs within assigned Therapeutic Area. •
Facilitates strategic scientific and operational input, maintenance, and continued evaluation of clinical development plans across programs.
Ensures timelines and deliverables are met across programs.
In conjunction with the Therapeutic Area Head/Section Head, responsible for resource management and deployment for assigned TA, including hiring and staffing.
Determines resource needs through the review of authorized and anticipated clinical development activities and applied knowledge of functional area and/or therapeutic area specific resource demands.
Manages and provides feedback and developmental opportunities for direct reports and staff.
Responsible for the annual budget for multiple programs within assigned TA and approves TA operational expenses.
Functions as representative or leads cross-functional /cross-divisional projects and initiatives. Represents organization on governance committees.
Core Skills
Demonstrated ability to drive and manage highly complex topics in clinical program operations. This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:
Influence opinions and decisions of internal and external customers/vendors, across functional areas, and withing division.
Engage strategically with key stakeholders across department, division, and company. Role requires proactive partnering, strategic thinking, and leadership to envision, plan, and execute operational and scientific excellence projects.
Strong decision-making and analytical skills. Ability to influence and drive a broader view of issues to maximize benefit and/or impact across oncology sections within the organization.
Strong people management skills to enable resource management and development management of direct reports.
Possess advanced understanding of end-to-end clinical research process. Excellent writing and communication skills
Demonstrated leadership skills in managing people, programs & processes, leading meetings and influencing matrix environments.
Advanced problem solving, conflict resolution, and critical thinking skills.
Expert knowledge of GCP and ICH regulations and corporate policies
Experience
Bachelor’s degree + 15 years OR Master’s + 12 years OR PhD/PharmD + 8 years Pharmaceutical and/or clinical drug development experience. Degree in life sciences, preferred. Organization leadership (e.g., program management) and people management experience.
CSSMHiring
MRLGCTO
#elgibleforERP
CSSMOncology
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$164,800.00 - $259,400.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aOfficial account of Jobstore.
Job Description
Access to our medicines is a strategic pillar for our organization and the Oncology Organized Customer Access and Reimbursement (OCAR) team is positioned to support that endeavor. Our goal is to provide profitable product access across our Oncology portfolio, and we engage with customers across the payer, provider, channel and policy spectrums to develop solutions that support patient access to our medicines.
As a part of our Oncology OCAR (Organized Customer Marketing Access and Reimbursement) team, the Director, New Product Payer Marketing (Individualized Medicine), will provide oversight in the development of payer and provider access strategies and promotional execution for our New Products portfolio. With a key focus on our individualized medicine portfolio (and any other new products as necessary) , the Director will collaborate with our Alliance Partner to align our value messaging, channel strategy, support of brand go to market strategies (ex. orchestration platform), field executions and resources for all payer customer segments (e.g. Health Plan / PBM (Commercial/Medicare/Medicaid),Federal, Community Oncology, IDN, GPO, Employer and Government) for all current and future indications.
Working closely with our Alliance partner and our Company's Oncology brand marketing teams, this role will be responsible for providing oversight, leadership and management that will include but not limited to the following:
Develop customer segment strategies to achieve profitable market access, support launch excellence and grow net income over time.
Develop a comprehensive payer strategy that are aligned to the brand marketing objectives. (Payer strategy development may include policy shaping across commercial and government payers, alignment and coordination with our policy teams as well as pre-approval information exchange with customers.)
Support pricing strategy and Gross to Net management of the brand.
Support the logistical capabilities needed to support the channel strategy and the go to market needs of an individualized therapy.
Develop payer value propositions and branded promotional initiatives for approved brand indications.
Providing US payer input into Global Access Teams, Outcomes Research and Business Development teams.
Responsible for the on-going planning, access messaging and access resource support for the field facing access teams (as necessary) ensuring consistency with customer segment strategies.
Partner closely with all stake holders (marketing communications, brand marketing teams, external promotion & market research agencies) to provide oversight and guidance to the Promotional Review Team (PRT) review process in support of the customer and brand marketing objectives.
Education:
Required: Bachelor's degree
Preferred: Master's degree
Required Experience and Skills:
Minimum of (8) years combined experience in Pharmaceutical Marketing, Marketing Customer Management, Managed Care/Payer Marketing or Sales.
Demonstrated experience with Marketing, Promotion Management, Managed Markets and Policy customer segments, Account Management and/or Customer Marketing.
Demonstrated understanding of healthcare trends and policy issues and their potential impact upon our Company's business opportunities.
Deep US segment Market Access experience.
Proven leadership skills with ability to lead across diverse departments, collaborating across stakeholders, and effectively engaging the senior management.
Demonstrated strategic & critical thinking, problem solving, analytical mindset & planning and communication (written/verbal) skills.
Preferred Experience and Skills:
Director Level of Marketing or Managed Care /Payer Marketing or Account Management
Experience in Oncology (IV and Oral)
Experience with individualized medicine, cell and gene therapies.
Position Location:
Upper Gwynedd, PA or Virtual/Remote based United States
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
RemoteShift:
1st - DayValid Driving License:
YesHazardous Material(s):
N/AOfficial account of Jobstore.
What You'll Do
Provides medical oversight and expertise in appropriateness and medical necessity of healthcare services provided to Plan members.
Conducts retrospective reviews of claims and appeals and resolves grievances related to medical quality of care.
Evaluates authorization requests in timely support of nurse reviewers; reviews cases requiring concurrent review, and manages the denial process.
Educates and interacts with network and group providers and medical managers regarding utilization practices, guideline usage, pharmacy utilization and effective resource management.
Facilitates conformance to Medicare, Medicaid, NCQA and other regulatory requirements.
Reviews quality referred issues, focused reviews and recommends corrective actions.
Develops and implements plan medical policies
Supports population health
Monitors appropriate care and services through continuum among hospitals, skilled nursing facilities and home care to ensure quality, cost-efficiency and continuity of care.
Ensures that medical decisions are rendered by qualified medical personnel, not influenced by fiscal or administrative management considerations, and that the care provided meets the standards for acceptable medical care.
Ensures that medical protocols and rules of conduct for plan medical personnel are followed.
Provides clinical expertise in support for quality improvement, sales, account, technology, investment and community engagement activities.
Works with Contracting Department in contract negotiation.
What You'll Bring (Hiring Requirements):
MD or DO in Psychiatry from an accredited medical school and completion of a residency training program.
10+ years of experience in the related field.
Current North Carolina medical license and/or Board certification in ABMS/AOA recognized specialty is advanced.
Occasional weekend work may be required.
Official account of Jobstore.
Are you a dynamic leader with a passion for driving sales in the life science industry? We are seeking a highly motivated and experienced Associate Medical Sales Director in Australia to join our team and lead our sales efforts in the medical sector.
From clinicians to data scientists, IQVIA has a global community of 86,000+ employees in more than 100 countries. We are a leading provider of innovative life science solutions, committed to improving patient outcomes and advancing medical research. Together, we harness the power of our unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
Job Overview:
As our Associate Medical Sales Director, you'll play a pivotal role in driving our company's growth and success in the medical industry. Your responsibilities will include developing and executing strategic sales plans to achieve revenue targets, building strong relationships with key stakeholders, leading, and mentoring the sales teams, identifying new business opportunities and market trends, and collaborating cross-functionally with other teams to ensure alignment and customer satisfaction.
You will be the primary point of contact for building and nurturing relationships with key stakeholders and your ability to understand their needs, address their concerns, and provide innovative solutions will be crucial in maintaining long-term partnerships and driving business growth.
In addition to leading the sales teams, you will play a hands-on role in mentoring and coaching team members to enhance their skills and performance. Collaboration will be key as you work closely with internal teams to align sales strategies with overall business objectives and your strategic thinking and results-driven mindset will be essential as we work together to make a meaningful impact in healthcare.
Qualifications:
Join us in our mission to make a difference in healthcare. Apply now to become our next Associate Medical Sales Director and the Talent Acquisition Team is looking forward to speaking with you!
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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Job Description
The Oncology Regional Medical Scientific Director (RMSD) is a credentialed (i.e., PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs). The role provides balanced, factual, scientific information about non-product areas of interest to the Company and replies to scientific questions from SLs, including questions about Company products. The work of an RMSD is aligned to: Scientific Exchange, Research, Scientific Congress Support, and Scientific Insights.
RMSDs liaise between the scientific community and the Company to enhance the comprehension of scientific foundations and goals for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies. The RMSD serves as a role model for other field medical team members in ways that include on-boarding and/or sharing of therapeutic expertise.
Location:
This position covers the territory of Washington, D.C., Virginia, & West Virginia. Applicants must reside within the assigned territory.
Up to 50% travel required with some overnight.
Responsibilities and Primary Activities:
Scientific Exchange:
Develops professional relationships and engages with national and regional SLs to ensure access to medical and scientific information on areas of therapeutic interest and Company products.
Conducts peer-to-peer scientific discussions and maintains a reliable presence with those SLs to ensure they have a medical contact within the company
Addresses scientific questions and directs SL inquiries on issues outside of RMSD scope (e.g., grants) to appropriate company resources consistent with applicable policies
Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI)
Research:
Upon request from Global Center for Scientific Affairs (GCSA),
Initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial
Enhances the comprehension of the scientific foundations and goals of investigator-sponsored research
Identifies barriers to patient enrollment and retention efforts to achieve study milestones
Upon request from Global Clinical Trial Operations (GCTO),
Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient enrollment and retention efforts to achieve study milestones.
Addresses questions from investigators and provides information regarding participation in company-sponsored clinical studies
Scientific Congress Support:
Engages in scientific congresses and medical meetings, facilitates scientific and data exchange for both internal and competitor data.
Scientific Insights:
Gathers feedback, data, or information during routine activities that can help the company better comprehend medical or scientific needs, priorities, or concerns of SLs and/or patients
Required Qualifications, Skills, & Experience:
Minimum:
PhD, PharmD, DNP, or MD
Proven competence and a minimum of 3 years of immuno-oncology experience beyond that obtained in the terminal degree program
Ability to conduct doctoral-level discussions with key external stakeholders
Dedication to scientific excellence with a strong focus on scientific education and dialogue
Excellent stakeholder management, communication, and networking skills
A thorough comprehension of FDA, OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers
Ability to organize, prioritize, and work effectively in a constantly changing environment
Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Access)
Desire to contribute to an environment of belonging, engagement, equity, and empowerment by:
Working to transform the environment, culture, and business landscape
Leveraging diversity and inclusion to increase competitive advantage, per global diversity and inclusion strategy
Ensuring accountability to drive an inclusive culture
Strengthening the foundational elements of diversity
Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities
Preferred:
Field-based medical experience
Experience in Thoracic Malignancies
Research experience
Demonstrated record of scientific/medical publication
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
50%Flexible Work Arrangements:
RemoteShift:
Not IndicatedValid Driving License:
YesHazardous Material(s):
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*This Position is Remote in North America*
The IQVIA Cell and Gene Therapy Center of Excellence, a hub of CAGT clinical innovation, is growing! We are looking for exceptional Board-Certified physicians to join our team as a Medical Strategy Lead to help us expand our CAGT portfolio and advance this dynamic and rapidly expanding area of clinical development.
The CAGT Medical Strategy Lead is a subject matter expert with experience in clinical research and clinical trials who will be a champion for CAGT across IQVIA.
The key remit of the role is drive growth of the IQVIA CAGT portfolio through scientific and clinical expertise. The Medical Strategy Lead will be charged with using his/her clinical, scientific, and operational knowledge to harness the vast IQVIA data and clinical trial resources to develop innovative, data-driven, and patient-centered solutions for CAGT trials.
The Medical Strategy Lead will provide senior clinical and scientific expertise to all IQVIA divisions as requested and will collaborate closely with indication-specific teams to develop integrated strategies for CAGT clinical trials and studies. The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in CAGT development.
As a subject matter expert, the Medical Strategy Lead will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.
RESPONSIBILITIES:
Accountable and responsible for creating innovative, evidence-based, and patient-centered delivery strategies and solutions for CAGT trials or studies, addressing the specific needs and challenges of each customer.
In partnership with Indication-Specific Medical Strategy, Operations, Sales, and other functions, responsible for award of strategic and tactical new business to achieve annual Gross New Business targets. Responsible for the inclusion of CAGT elements into proposals.
Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
Support preparation of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys CAGT strategy. Attends and presents at customer meeting, or bid defense or partnership meetings, as required.
Participates in strategic business development activities including presentations to prospective clients and professional meetings.
Maintains awareness of industry pipeline and scientific and business landscape; supports due diligence research of the CAGT landscape
Leads CAGT thought leadership at IQVIA which may include publications, presentations, and taking a leadership role in scientific activities
REQUIREMENTS:
Scientific and Research Qualifications and Experience
A physician with experience in Cell and Gene Therapy. A degree from an accredited and internationally recognized school is required
5+ years clinical research relevant experience, including hands on operational delivery and/or drug development experience
Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in CAGT
Excellent skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; e.g. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall offering
Strong clinical research skills and commitment to evidence-based and patient-centered clinical development
Professional Skills
Excellent communication, presentation and interpersonal skills, including good command of English language (both written and spoken)
Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organization
Innovative and strategic thinker
Strong business acumen including confidence with financial considerations, excellent negotiation and influencing skills, and comfort working in both sales and operational environments
Flexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when required
Confident and capable in the use of technology, applications and other media e.g. databases and internet to research assess new opportunities, maintain currency of therapeutic and operational knowledge and competitive landscape.
Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results
Interpersonal Skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients. Maintains a positive outlook at work; handles criticism well and learns from it
Ability to establish and maintain effective working relationships with a wide network of individuals e.g. coworkers, managers and customers
Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $190,900.00 - $325,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.Official account of Jobstore.
The Role:
Moderna is seeking a Director of Clinical Operations to manage Oncology programs which may consist of one or more studies. This position will be responsible for initiating and leading clinical programs, inclusive of studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Executive Director, Clinical Operations, Oncology. This position will work collaboratively across the Oncology and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects.
Here’s What You’ll Do:
Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders
Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs
Support the selection, oversight, and management of CROs and other vendors
Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders
Perform and document study level Sponsor Oversight of outsourced clinical activities
Communicate study-status, cost and issues to ensure timely decision-making by senior management
Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna
Support program level deliverables/activities
Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work. May include direct line management of Clinical Operations staff.
Strive for continuous improvement and more efficient ways of working in clinical development
Act as a role model for Moderna’s values
Here’s What You’ll Bring to the Table:
Minimum of BA/BS with at least 10 years of trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience and 2+ years of program-level management Advanced degree preferred.
Experience in Immuno-Oncology is required. Experience in both solid tumors and hematologic malignancies is desirable. A mixture of early and late stage experience is desirable, some early development experience is required.
Robust experience in early and late phase drug development
Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
Experience in GCP inspections/audits
Outstanding verbal and written communication skills, in addition to excellent organizational skills
Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
Resilient, Creative, capable problem-solver
Excellent organizational skills and ability to work independently
Experience in establishing and maintaining relationships with key opinion leaders
Some travel required
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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The Role:
Reporting directly to the Senior Director or Executive Director of Medical Writing, this pivotal role carries the significant responsibility of ensuring the delivery of high-quality clinical and regulatory writing. From meticulous planning and coordination to delivering the final drafts, the role demands a keen eye for detail and a robust understanding of the clinical development landscape. This individual will form an integral part of Moderna’s clinical development team, working closely with them to understand and contribute to the broader objectives of Moderna’s clinical development program. This is not just a job, it's an opportunity to drive change and make a difference in the world of biotechnology.
Here’s What You’ll Do:
Functional Knowledge: Demonstrate a comprehensive understanding of concepts and principles for overseeing the managing medical writing and regulatory writing across multiple clinical development programs.
Document Planning & Project Management: Oversee the planning, writing, and reviewing of clinical and regulatory documents and responses.
Cross-Functional Collaboration: Work closely with cross-functional teams to ensure timely delivery of high-quality documents.
Regulatory Compliance: Ensure all documents comply with regulatory guidelines.
Data Interpretation: Interpret clinical and statistical data to prepare clear, concise documents.
Quality Control: Implement and oversee quality control processes for medical writing.
Document Updates: Manage the updates and revisions of documents as required.
Problem Solving: Direct the resolution of highly complex or unusual business problems applying advanced critical thinking.
Impact: Guided by functional plans, impact the quality and timeliness of the functional area and results, and develop area plans.
Develop and Implement Departmental Strategies: Set goals and objectives for the medical writing team that align with the company's overall strategy.
Line Management: Oversee and manage the performance of a high-performing medical writing team, providing guidance, feedback, and mentorship. Responsible for hiring, training, and professional development of team members. Ensure resources are allocated effectively and deadlines are met consistently. Foster a collaborative and positive team environment.
Here’s What You’ll Bring to the Table:
Education: Advanced degree (preferred) with a minimum of 10 years of relevant experience OR bachelors degree with a minimum of 15 years of relevant experience.
Industry Experience: Proven experience in clinical development, regulatory affairs, or medical affairs.
Interpersonal Skills: Ability to influence others internally and/or externally, including colleagues in other departments. Some negotiation with limited impact may be required.
Leadership Skills: Ability to lead dynamically through senior managers or professionals. Translate and execute functional business strategy across multiple related disciplines and contribute to strategic planning for medical writing.
Business Expertise: Apply market knowledge to drive integrated results across multiple related teams.
Communication Skills: Excellent written and oral communication skills.
Quality: Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.
Technical Skills: Proficiency in MS Office and familiarity with medical writing software.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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Official account of Jobstore.
Job Overview:
As a Lead Medical Writer on most types of writing projects. You will prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Perform Senior Review of straightforward medical writing deliverables. Negotiate timelines and discusses/resolves customer comments. Provide written and verbal feedback to junior staff, and to customers when appropriate. Keep abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.
Responsibilities:
Writes clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus.
Contributes to project plan concerning timelines as well as organization and table layout for a specific document.
Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.
Review and edit documents for consistency, progression, structure, and grammar.
Review statistical analysis plans and incorporate into clinical study reports or submission documents, as applicable.
Drive the document preparation process, manage timelines, receive, and review primary statistical output, draft, and distribute document for review, compile comments and edits, lead comment resolution meetings independently.
Participate in team and client meetings as requested. Deliverables above plus able to work independently on a range of complex clinical documents
Interprets, summarizes, and presents statistical and medical information to ensure accuracy of content in highly complex document types independently
Resolves complex problems independently
Education and Experience required:
8+ years of experience in medical writing or related field
Required - Bachelors Degree in Life Sciences or related field
Preferred - Masters or PhD in Life Sciences or related field
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $124,400.00 - $211,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.Official account of Jobstore.
Official account of Jobstore.
