Job Description
Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.
Role Summary
The Country Medical Director (CMD) is the Senior Medical Leader in a country and serves as the leader of the Value & Implementation (V&I) Global Medical Scientific Affairs (GMSA) organization in their geography.
CMD is the primary country level contact for GMSA.
What You Will Do
Key responsibilities
- Coordinates Development and execution of the Medical Affairs (MA) strategy for the country
- Creates and maintains a high-performing, highly-compliant MA organization for the country.
- Manages the entire portfolio for our company, allocates resources balancing global and local priorities;
- Represents our company Research Laboratories (our research lab) or GMSA in the Country Leadership Team; and in cross-functional collaborations with other our research lab functions, Human Health (HH) and others;
- Communicates accomplishments, opportunities, and needs of the country to regional and/or global stakeholders;
- Represents our company in external activities requiring the leadership and expertise of the country's Senior Medical Leader.
Responsibilities And Primary Activities
Leadership and Management of the Medical Affairs Organization
People
- Lead in a matrix organization thru shared leadership with TA Leads, Medical Advisers based in the country
- Proactively identify new opportunities and also gaps vs emerging needs and address in a timely manner by reallocating and training of existing staff and/or external recruitment;
- Create an empowering, compliant, collaborative, and innovation-focused work-environment;
- Build a culture of quality and compliance through training, oversight, and collaboration.
Country Medical Affairs Plans (CMAPs)
- Coordinate the development and execution of CMAPs, including tactical deliverables for each of the therapeutic areas, such as post-licensure research, publication plans, investigator- initiated studies, and other knowledge transfer activities;
- Ensure alignment of the CMAPs with global strategy and adherence to all relevant regulations, Policies and Standard Operating Procedures (SOPs);
- Coordinate the country developed Protocol Concept Sheets (PCS), obtain regional and global approvals for new local and manage their execution .
Medical Affairs Management
- Manage approved operating administrative (e.g. salaries & travel) and life cycle management budget (e.g. Advisory boards, Local Data Generation etc.);
- Oversee inspections and inspections audits, answering inquiries by health authorities, ethical committees, and internal auditors in conjunction with Regulatory, PV and Global Clinical Trial Operations (GCTO).
What You Must Have
Responsibilities and Primary Activities, continued
Collaboration with Key Internal Stakeholders
The CML represents Medical Affairs in cross-functional leadership teams and collaborations, and advocates for the interests of the country (or cluster) with regional and global colleagues.
Country Leadership Team
- Represent Medical Affairs and be the medical voice in the country executive management team.
Global Clinical Trial Operations (GCTO), Global Regulatory Affaris & Clinical Safety (GRACS)
- Support for GCTO when requested;
- Manage the submission and our research lab roles in the conduct of Investigator-Initiated Studies;
- Lead country review of Compassionate Use Requests and Pre-License Patient Access (PLPA) programs and facilitate Chief Medical Officer (CMO) approval of these requests.
- Support to the Local QPPV as medical qualified person.
Outcome Research (OR), Market Access, Regulatory Affairs, HH and Policy
- Interact with OR, Market Access, and Global Medical Affairs experts to develop and manage observational, real-world effectiveness and epidemiologic studies;
- Collaborate with OR, market access, regulatory and commercial colleagues by providing scientific expertise and managing the medical aspects of submissions for regulatory, reimbursement or tenders for our company entire portfolio of medicines and vaccines;
- Provide medical expertise to the commercial product teams, ensuring the scientific and medical value of our company's products across all therapy areas.
Engagement with Key External Stakeholders
The CMD represents our company as an executive leader and scientific expert to the external community.
- Serve as external interface with key stakeholders, insurers/government leaders, selected professional societies, medical-scientific institutions and the broader scientific community to lead and execute the medical research and implementation strategy for our company's innovative medicines, ensuring that the medical community is appropriately engaged with the information they need to support patient care needs (e.g., scientific advisory boards, SL engagements, webinars and presentations).
- Collaborate with OR, Market Access, and Commercial colleagues to engage payers, policymakers, and other decision-makers in support of our companys innovative portfolio of medicines and vaccines.
- Build a network of key scientific leaders in areas of relevance to current and anticipated needs.
- Develop and/or foster relationships with external stakeholders to ensure that robust local insights from Health Care Providers (HCPs) and patients are gathered and integrated into local, regional and/or global strategies, plans and tactics, enabling the generation of data needed by payers, physicians, and patients to properly understand and value our innovative medicines and vaccines.
- Participate in outcomes research/ health economics engagements with national payers, Health Technology Assessment (HTA) or regulatory agencies, in coordination with OR, Market Access, and Commercial colleagues.
- Provide scientific subject matter expertise for media relations and public affairs to country Communications, Corporate/External Affairs, and Public Relations teams; and serve as official spokesperson for scientific matters.
Required Qualifications, Skills & Experience
Minimum
- M.D. or equivalent degree;
- Global biopharmaceutical industry experience in clinical development and/or medical affairs with demonstrated track record of success minimum 7 years
- People-management experience minimum 5 years
- Demonstrated organizational skills, including ability to set goals and align priorities;
- Deep experience in our company therapeutic areas of interest (e.g., oncology, infectious diseases treatment, vaccines, or specialty care);
- Budget management experience.
Preferred
- Additional advanced degrees, entry on a specialist register (pharmaceutical medicine or a relevant clinical specialty) and a current license to practice are a strong plus;
- Specialty clinical training (i.e., a residency +/- fellowship).
Who We Are
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What We Look For
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join usand start making your impact today.
Current Employees apply HERE
Current Contingent Workers apply 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
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Not Applicable
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
11/19/2024
- A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID R321025
