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Job Description:
The Region Director Clinical Ethics establishes the structure and processes for Ethics Committees and Ethics Consultation teams throughout the Peaks Region and works toward full implementation of Proactive Integrative Ethics. The Region Director provides on call support when needed to all Care Sites in the Peaks Region for complex situations.Along with offering a chance to work in a stable, strong, mission-based environment, the Region Director of Clinical Ethics provides the opportunity to experience Colorado’s diverse culture and incredible landscape. You’ll be able to explore abundant outdoor recreational opportunities, including skiing, hiking, and fishing, as well as stunning national parks and forests, all within hours of where you’ll call home. Becoming a part of the Intermountain team means gaining a family and finding a place to plant your roots.
Benefits are one of the ways we encourage health for you and your family. Our generous package includes medical, dental, and vision coverage. But health is more than a well-working body: it encompasses body, mind, and spiritual well-being. To that end, we’ve launched a Healthy Living program to address your holistic health. Healthy Living includes financial incentives, digital tools, tobacco cessation, classes, counseling, and paid time off. We also offer financial wellness tools and retirement planning.
This is an exempt, full-time position located in the Front Range of Colorado (Denver Metro area). To show our commitment to you and assist with your transition into our organization, we may offer a sign-on and relocation bonus when applicable.
With this position, you are eligible to participate in an annual pay-for-performance opportunity (“AP4P”). This plan enables Intermountain Health to provide leaders with an additional performance compensation opportunity. The AP4P opportunities are calculated as a percentage of your base salary. Awards are paid out based on attainment of selected Intermountain Health Board-approved goals.
The Region Director Clinical Ethics reports directly to the Region Vice President Ethics and Church Relations and works collaboratively and in close communication with Regional Vice Presidents of Mission Integration, Mission leadership, Ethics Committee Chairs, clinical staff, and the Chief Catholic Mission Officer.
As the Region Director of Clinical Ethics, you will:
Continue to build the Ethics infrastructure to fully implement, support and maintain Proactive Integrative Ethics at all care sites in a manner that supports and demonstrates value to patient care and the patient experience.
Collect and compile statistical information to demonstrate the value of Proactive Integrative Ethics on patient care, length of stay, readmission rates, and in terms of financial return on investment, etc.
In collaboration with the chairs of the care site ethics committees, assess the needs of each Ethics Committee, and develop and deliver a structured plan to educate and equip Ethics Committees and Consultation Teams to function with a high degree of skill and autonomy.
Continue to build consistency in the structure and delivery of Clinical Ethics throughout the Peaks Region.
24-hour availability in providing support to Ethics Committees is required, as well as periodic coverage for the Region Vice President Ethics and Church Relations.
Round with ICU teams and other high utilization care teams providing education and assistance in implementing Proactive Integrative Ethics.
Provide education, seminars, materials, and presentations to nursing, medical and support staff, residency programs, and other identified groups on Clinical Ethics and Proactive Integrative Ethics.
Be accountable for compliance with the Ethical and Religious Directives for Health Care Services.
Assess and develop a plan for proactive integrative ethics support and education in the ambulatory (clinic) setting.
Support and provide presentations and training in collaboration with the Formation programs developed and offered by the Formation department.
Minimum Qualifications
Master’s degree in Ethics or equivalent education, required
Doctoral degree, preferred
Clinical health care ethics experience, required. Along with demonstrated evidence of understanding and ability to represent and apply the moral teachings of the Catholic Church to clinical ethics matters.
Experience in ethics collaboration in a broad spectrum of healthcare environments, required
“Healthcare Ethics Consultant – Certified”, preferred
Knowledge: Demonstrates a thorough familiarity with a fluency in the Ethical and Religious Directives for Catholic Health Care Services and understanding of the Catholic moral tradition in pluralistic contexts.
Communication skills: Ability to communicate with a wide variety of associates, clinicians, patients, and leadership. Excellent presentation skills are required with fluency in developing electronic presentations. Proficiency in collaboration and networking skills are required. Strong oral and written communication skills are required.
Ability and discipline to work semi-autonomously: Is able to work and meet task expectations with minimal amount of direct supervision. Requires a capacity for prioritizing tasks, meeting performance standards, and exercising accountability in a matrix reporting structure.
Leadership skills: Must demonstrate ability in working with diverse groups of stakeholders to move to common goals and decisions. Must be able to form and foster group cohesion. Have capacity to tolerate ambiguity and navigate power dynamics.
Technology: Must be able to use/learn to use the comprehensive electronic medical record. Ability to use Microsoft Office tools.
Travel: Willingness to travel as needed and as assigned.
#LI-EXECRC
Physical Requirements:
Interact with others by effectively communicating, both orally and in writing.- and -Operate computers and other office equipment requiring the ability to move fingers and hands.- and -See and read computer monitors and documents.- and -Remain sitting or standing for long periods of time to perform work on a computer, telephone, or other equipment.- and -May require lifting and transporting objects and office supplies, bending, kneeling and reaching.Anticipated job posting close date:
04/05/2024Location:
Peaks Regional OfficeWork City:
BroomfieldWork State:
ColoradoScheduled Weekly Hours:
40The hourly range for this position is listed below. Actual hourly rate dependent upon experience.
$47.58 - $87.26We care about your well-being – mind, body, and spirit – which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged.
Learn more about our comprehensive benefits packages for our Idaho, Nevada, and Utah based caregivers, and for our Colorado, Montana, and Kansas based caregivers; and our commitment to diversity, equity, and inclusion.
Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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At Compassus, we know that caring for our teammates is the first step in caring for our patients. We are committed to providing Care for Who You Are and What You Need to balance work and life including flexible scheduling, a supportive family-focused culture and first-class compensation and benefits.
Your position perks as a Hospice Director Clinical Services (Registered Nurse/RN)
How you’ll make an impact as a Hospice Director Clinical Services (Registered Nurse/RN)
Hospice Director Clinical Services (Registered Nurse/RN) Requirements
Hospice Director Clinical Services (Registered Nurse/RN) Certifications, Licenses and Registrations
Care for Who I Am is Caring for Who We Are. Together We Are:
Welcoming everyone. Empowering belonging. Allying for inclusivity. Removing barriers. Engaging community.
WE ARE fostering an inclusive environment where every teammate matters and can be their best selves.
WE ARE becoming a reflection of our patients, families, and partners.
WE ARE transforming care at home for every community serve.
#LI-MM2
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The Role:
The Program & Portfolio Management Office (P&PM) at Moderna is responsible for management of the development portfolio from lead nomination to licensure. Moderna is seeking a motivated and energetic Associate Director of Governance & Portfolio Operations to enable continued execution and improvement of governance across the development portfolio. The successful candidate will work in close coordination with the PPM Leaders, Clinical Development Organization, Finance, Strategy, CMC and Key Functional Heads across the organization. This role presents an exciting opportunity to further establish and improve a new function at Moderna that will continue to scale and drive value as the portfolio expands.
Here’s What You’ll Do:
Support ongoing business planning processes including but not limited to quarterly budget and resource planning cycle, long-range planning, supply planning and program goal setting, through driving key PPM processes and identifying key gaps, risks and challenges across the portfolio
Work closely with PM to facilitate cross-learnings & drive PPM process improvement initiatives that will evolve a set of common operating standards, tools and templates
Maintain multi-year roadmap of the portfolio to support robust analysis and aid in executive-level decision-making; by defining and implementing processes to gather and track program and portfolio data as well as supporting the build and maintenance of high-quality portfolio and program datasets and models
Provide oversight and management of Governance Committees; partnering on strategies for bringing forward timely discussions to foster early planning, providing line of sight into key upcoming discussions, leading preparatory meetings and tracking key outcomes
Collaborate with PPM, program and functional leaders across the organization to define and implement enhancements to governance and proactively identify and escalate risks, gaps and challenges
Support generation and reviews of monthly development program updates to executive committee and board of directors
Drive key stakeholder engagement (i.e. Therapeutic area, Franchise and Program Leads, Program Managers, Functional Leaders)
Partner with Portfolio Analytics (PA) team to evolve and embed reporting and key information into governance & other PPM processes
Serve as development portfolio and governance process subject matter expert
Here’s What You’ll Bring to the Table:
BS degree with 10 years’ experience in a biotechnology or pharmaceutical setting required
MS or MBA and 12+ years of experience, PMP certification preferred
Demonstrated experience building or leading a governance function
Experience in drug development, preclinical through clinical development
Strong analytical skills, business knowledge and understanding of clinical development drivers
Effective at managing complex, highly dynamic, scientific & technical organizations to work collaboratively towards a generation of new medicines
Experience building capabilities and development portfolio level processes
Proven ability to analyze, develop and contribute to development of conceptual plans and lead implementation of process improvements and change initiatives across the organization
Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally
Strong personal skills to influence without authority within a highly technical environment, motivate others and manage conflict.
Demonstrated experience interacting with senior and executive leadership.
Strong written and oral communication skills as well as demonstrated organizational aptitude
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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Job Description
The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Research & Development Division portfolio of clinical trials. GCS supports more than 300 Phase I-IV clinical trials run in-house, 400+ outsourced or run by partners, and 300+ our Company ISS clinical trials. GCS is accountable for the planning, sourcing, labelling, packaging and delivery of clinical supplies to clinical sites across more than 60+ countries, in accordance with US and Global regulations, company policies, and Standard Operating Procedures.
The GCS Clinical Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business. Clinical Supplies Project Managers (CSPMs) are responsible for the translation of global clinical study demand into supply plans and are accountable for all delivery of clinical finished goods materials to initiate trials on time and maintain patient continuity of supply.
Reporting to the Section Head of one of the Therapeutic Areas, the incumbent will have responsibility to manage a team of Clinical Supply Planning Managers (CSPM) responsible for managing supporting clinical supply programs, protocols and/or inventory. Responsibilities may also include assignments of varying phase, complexity, priority & involvement with external collaboration partners.
Primary Responsibilities:
Manages, directs, and influences clinical supply planning strategy, design and execution for multiple highly complex programs ensuring scientific consistency and quality development across multiple key clinical programs within a Portfolio. Accountable to Sr. Management for communication of progress, status updates, mitigation plans and escalation of issues for clinical supply deliverables across the portfolio for Phase I thru Phase IV including IIS and collaborative studies. Facilitates strategic and operational input, maintenance and continued evaluation of clinical supply chain plans across programs. Partners with key stakeholders to align with the vision and strategy and to ensure clinical supply timelines and deliverables are met across programs (including joint ventures, collaborations, due diligence, etc.).
Partners with key stakeholders on leadership teams to build alliances, drive the direction of the business, leverage best practices, and develop leading indicator values for risk, change control, and business continuity. Keeps abreast of pharmaceutical industry best practices, regulatory and GMP requirements and corporate strategies that impact the organization
Manages the multi-million dollar clinical supply drug product budget across the assigned Portfolio. Works cross-functionally with Clinical Research and Operations, Business Analytics, Finance, and other critical stakeholders to support the needs, influence and drive business performance, and ensure effective planning strategies for clinical supplies.
Responsible for resource management and deployment for the Portfolio, 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 specific resource demands. Manages and provides feedback and developmental opportunities for direct reports and staff. Provides mentoring for planning managers and team leads.
Functions as representative or leads cross-functional /cross-divisional projects and initiatives.
Additional Responsibilities:
Coach and mentor staff in the nuances of managing a development project: management of team dynamics, understanding stages of development and how functional inputs interact to ensure project progression, coaching on our Company processes relating to development team management, PM skills, and team management. Strengthen messaging via exhibition of our Company Leadership Behaviors (teach by example).
Work to ensure that PM best practices are being employed across projects.
Participate in continuous improvement projects that require extensive product development experience and understanding of our Company procedures and policies, and which significantly impact the work and / or effectiveness of PM. These projects can relate to optimizing PM capabilities, systems, and operations (e,g., leading efforts to improve planning systems / platforms, etc.) or to improving the functioning of teams and / or development processes. These efforts may be within GCS or cross functional to assist other partner areas with their process improvement needs
Required Education and Experience:
Bachelor’s degree with 10+ years’; or Master’s degree with 8+ years’; or relevant career experience.
At least 5 years of experience in supply chain management (demand planning/forecasting) and/or project management.
Strong understanding of drug development, clinical research, and/or clinical supply chain activities.
Strong interpersonal skills with a demonstrated ability to negotiate with key stakeholder groups and drive/influence results in a dynamic environment.
People management and strong leadership skills.
Understanding of MRP systems and demand planning principles
Strong organizational, time management and problem-solving skills
Results oriented with the proven ability to execute on collaborative projects and develop subject matter expertise
Exceptional written and verbal communication and relationship skills along with high personal integrity, credibility, and energy.
Demonstrated ability to prioritize tasks and initiatives appropriately to mitigate supply risks.
Proficiency in Microsoft Excel, PowerPoint, and Word.
Experience with change management and leading process improvement initiatives.
Preferred Experience and Skills:
Extensive experience with the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management (can be R&D, manufacturing or commercial perspective), with demonstrated ability to translate knowledge and expertise to other development teams and areas.
Demonstrates ability to resolve conflicts and engage in decision making as well as partner and influence across functional areas and organizations
Strong knowledge of the principles of project management and clinical customer relationship management.
Knowledge of drug development, production, distribution, shipping, destruction, and reconciliation processes and procedures.
Knowledge of order management, supply chain operations and document control.
Familiarity with data analytics/visualization software.
Familiarity with SAP as an ERP/MRP system.
Familiarity with GMP requirements, quality procedures, and SOP execution.
GCSCareer
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:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
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Job Description
General Summary:
The Senior Medical Director will define the clinical development strategy of an assets across programs, work with cross-functional multidisciplinary teams to define overall asset strategy as well as clinical trials strategy, design and execution, and may serve as the Medical Lead for clinical trials that will be conducted with these compounds.
Key Duties and Responsibilities:
Knowledge and Skills:
Education and Experience:
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex 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, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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 recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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For over 100 years, at Riverside Health System, we have made it our mission to care for others as we would care for those we love.
Riverside is currently seeking a Senior Clinical Director of Operations for our growing Medical Group.
This dynamic leader will work alongside our providers and senior leaders to ensure accordance with our standards of excellence as we fulfill our mission to care for others as we would care for those we love!
You will have direct oversight of clinical operations in our 110 medical practices throughout Southeastern Virginia, ensuring we continue to deliver exceptional patient centered care and fulfill our mission!
What you will do
Qualifications
Education
Experience
Licenses and Certifications
To learn more about being a team member with Riverside Health System visit us at https://www.riversideonline.com/careers.
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Job Description
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be tasked with the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach. They will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.
Primary Duties:
Operational Quality Management:
Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT.
Collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.
Responsible for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to: 1) Facilitating and monitoring CTT oversight of vendors; 2) Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies); and 3) Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. Non-Governmental Organization (NGO), government or academic institutions).
Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.
In partnership with the CQOL, the CQOM will develop skill sets in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials).
Build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions and regional study management.
In collaboration with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle.
Inspection Preparation and Management:
Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.
Lead and support GCP inspections, worldwide. The CQOM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.
Team up with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO).
Contribute to the development and/ or revision of our Company policies, SOPs and training materials.
Develop the strategy for management/support for GCP inspections of our Company products to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation, management and follow up) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory compliance.
Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
In partnership with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and Corrective Action and Preventive Action (CAPAs), worldwide.
Act as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance.
Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management.
Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
CAPA Management Support:
Ensure that all actions and commitments related to audits and inspections are implemented in a timely manner. Track all inspection CAPA and regulatory commitments and checks evidence of completion.
Ensure repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.
Provide guidance and support for CCQMs regarding inspections at a country level sites that require a company headquarters input.
Other activities:
Provide input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.
Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.
Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.
Education:
Bachelor’s degree or equivalent in relevant health care area. Advanced or formal education in quality management or business management is preferred.
Experience:
Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.
Knowledge and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.
Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
Experience with delivering effective CAPA management solutions.
Experience with risk management tools and processes within the clinical quality framework.
Skills:
Superior oral and written communication skills in an international environment.
Ability to manage and develop others, including formal performance management when required.
Excellent project management and organizational skills.
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
Lead cross-functional teams of business professionals within and outside our Research Division.
Act urgently for worldwide health authority inspection matters.
Analyze, interpret and solve complex problems.
Think strategically and objectively and with creativity and innovation.
Effectively interact with all levels of specialists & management and exert influence to achieve results.
Identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.
#EligibleforERP
MRLGCTO
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.
Residents of Colorado
Click here to request this role’s pay range.
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:
$135,500.00 - $213,400.00Available 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:
25%Flexible Work Arrangements:
RemoteShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aOfficial account of Jobstore.
Job Description
The Associate Director, Clinical Supply Operations (CSO) within Global Clinical Supply (GCS) is responsible for supporting launch and subsequently overseeing the clinical supply packaging and distribution operations at our Company at Rahway Cold Chain Center. This role involves working with stakeholders, subject matter experts, and customers within and outside of GCS to ensure efficient and compliant processes, as well as business continuity.
Key responsibilities of the Associate Director, Clinical Supply Operations include:
Supporting the implementation and leading the operational readiness of a new clinical cold chain supply packaging and distribution operation in Rahway.
Overseeing the Cold Chain Center's distribution, inventory, and warehouse activities, including inventory management, metrics, utilization, and inspection readiness once the facility is live.
Ensuring efficient and compliant processes by owning and contributing to the development of standard operating procedures (SOPs) specific to the Cold Chain Center as well as ensuring representation of the Cold Chain Center in harmonized global procedures.
Effectively collaborate with other CSO nodes, including partner group interaction optimization (Packaging, Label Room, Ops Planning, Quality, Master planning, Bulk manufacturing, Analytical for cleaning/swabbing/investigations) to enable business continuity and portfolio needs
Build partnership with quality teams to ensure agility and speed in meeting portfolio needs.
Flexibly managing responsibilities and activities across CSO workstreams to support the business.
Collaborating closely with Global Clinical Trial Operations (GCTO) and Regulatory teams to ensure regulatory needs are included in the clinical supply chain and on-time arrival of products.
Conducting capacity modeling and resource management, including presenting to leadership.
Partnering with drug product manufacturing to develop, implement, and maintain playbooks and processes for integrated operations within clinical supply.
Seeking opportunities for innovation and process improvement, and supporting change as needed.
Education Minimum Requirement:
Bachelor's Degree in Engineering, Supply Chain, Business, or related field.
Required Experience and Skills:
At least 7-10 years of experience in production operations, technical project management, engineering, and/or management role within the pharmaceutical industry, with an understanding of clinical supply needs, GMP, packaging, and distribution operations.
Experience in pharmaceutical packaging and distribution operations will be highly valued.
Strong understanding of current Good Manufacturing Practices (cGMP), including FDA and EMEA requirements.
Experience in leading teams, developing talent, and mentoring or leading complex projects.
Demonstrated strong project leadership of cross-functional teams through project planning and execution.
Experience in collaborating with vendors or other external partners.
Ability to work effectively across boundaries and build strong collaborative relationships with other groups.
Strong abilities in stakeholder management and building cross-functional networks.
Excellent communication skills with the ability to effectively communicate with different global professional levels and external stakeholders.
Demonstrated ability to prioritize tasks and manage multiple responsibilities.
Preferred Experience and Skills:
Experience with cold chain clinical supply packaging and distribution operations
Experience with clinical trial operations
Familiarity with SAP
Operations Management Certification (i.e., APICS (American Production and Inventory Control Society))
Six Sigma certification (i.e., Green or Black Belt).
Project management, lean six sigma, scheduling practices preferred
Comfortable with Microsoft suite of applications
Dedication to solving complex problems with a creative mind and imaginative strategies.
Understanding of scheduling and capacity modeling to ensure appropriate resourcing.
GCSCareer
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”.
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:
$122,800.00 - $193,300.00Available 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:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aOfficial account of Jobstore.
At Compassus, we know that caring for our teammates is the first step in caring for our patients. We are committed to providing Care for Who You Are and What You Need to balance work and life including flexible scheduling, a supportive family-focused culture and first-class compensation and benefits.
Your position perks as a Hospice Director Clinical Services (Registered Nurse/RN)
How you’ll make an impact as a Hospice Director Clinical Services (Registered Nurse/RN)
Hospice Director Clinical Services (Registered Nurse/RN) Requirements
Hospice Director Clinical Services (Registered Nurse/RN) Certifications, Licenses and Registrations
Care for Who I Am is Caring for Who We Are. Together We Are:
Welcoming everyone. Empowering belonging. Allying for inclusivity. Removing barriers. Engaging community.
WE ARE fostering an inclusive environment where every teammate matters and can be their best selves.
WE ARE becoming a reflection of our patients, families, and partners.
WE ARE transforming care at home for every community serve.
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Official account of Jobstore.