Job Description
Position Overview:
Under the general supervision of the Medical Director, the Medical Affairs Manager (MAM) manages the medical activities for one or more therapeutic area(s). MAM is a partner with marketing and market access regarding all relevant activities related to the therapeutic y area(s). In compliance with all applicable country regulation and our company's policies and procedures, the MAM is responsible for the following aspects:
• Contributing to short and long-term business objectives by optimizing medical and clinical excellence throughout the product life cycle within the therapeutic area.
• Developing Medical Affairs strategy via Medical Affairs Plan (MAP) for incumbent's therapy area(s) in the country and takes appropriate action to ensure proper implementation and appropriate management of budget related to these activities.
• Establishing, managing and owning high level of scientific and clinical interactions with customers: Scientific leaders, speakers, investigators, scientific societies or the like.
• A major part of the MAM role is maintaining high level of scientific interaction with customers, hence at least 50% of the job should be spend on customer interactions in the form of emails, telephone calls, face-to-face meetings whether pre-scheduled (congresses, symposia) or un-scheduled.
• Providing medical and scientific advice and input for business strategies, market access and others as required, as well as input into health economics.
• Being recognized by customers and colleagues as our company's expert in therapeutic area.
• High level scientific and medical/clinical interactions with regulatory and reimbursement authorities.
The incumbent is expected to have appropriate knowledge and qualification, possess a good understanding of the relevant therapeutic areas, a strong working knowledge of all applicable local regulations and our company's global policies, procedures and processes. Ability to work effectively in a matrix organization and collaborate with colleagues on international level are highly desirable qualities.
Primary activities include, but are not limited to:
Strategic Activities
Planning and implementation of local Medical Affairs activities within the therapy area(s). Enhancing company reputation and profile by representing the company in relevant external and internal cross-functional, regional task forces or boards (e.g. internally: Cluster Team, Regional Medical Affairs Team (RMAT)) where relevant and feasible.
Developing Medical Affairs Plan (MAP) including relevant strategies related to:
Brand imperatives, key medical activities, outline specifics for the country (e.g. different standard of care, reimbursement timeline different than others, etc.). Prioritize and define development areas to meet all scientific- and medical needs and clinical care gaps. Identify scientific leaders and topics for discussion needed, as well as developing tactics including, but not limited to:
• Management and execution of the GMA portfolio of medical programs and local studies within agreed timelines and budgets
• The planning, initiation and implementation of Local Data Generation programs including preparation/review of protocols as needed in alignment with product franchise strategy, securing Sr. Management Approval. MAM must secure final clinical study report / manuscript and ensure the publication of LDG.
• Secure input to HQ-sponsored study allocation as well as national our company's site selection and investigators. Maintain and update information for local study feasibility on continuous basis and provide timely reply to HQ Request for Information for local study feasibility
• Implementing publication policy for the therapy areas, e.g. securing production of review articles or the like.
• Actively search for meetings, symposia, congresses, Continuous Medical Education (CME), research grants/fellowships which could bring additional value to the relevant therapy area.
External Scientific and Medical Interaction
• Securing our company's keeps role of scientific leader by developing and managing a frequent and sustained dialogue with scientific leaders, investigators, and speakers.
• Plan and execute national and regional Advisory Boards.
• Contribute to our company's sponsored meetings and CME events, including engaging Scientific Leaders as speakers, development of slide kits and giving own lecture as relevant active participation in symposia and congresses.
• Contribute to formulary and clinical guideline development.
• Provide medical and scientific training and support/advise to internal customers, provide tailored responses to customers’ requests for Medical Information.
Internal Scientific and Medical/Clinical Interaction
• Providing internal medical expertise, support/advise within the therapeutic area to colleagues. Market Access for access plans and programs including pricing, reimbursement and public affairs.
• Providing support to Regulatory department (support in translation checking (SmPC/PIL), DDLs, Safety information/training materials).
• Providing support to pharmacovigilance (compliance with reporting requirements).
• Ensure clinical and scientific accuracy of promotional materials through effective execution of the worldwide review process.
Skills
• Preferred proficient understanding of the drug development process, relevant diseases and therapies, and the local medical practice
• Demonstrating strongly ethics and integrity
• Excellent interpersonal skills related to management of scientific leaders and authorities
• Collaborative problem-solving approach within the team Excellent presentation skills
• Strong leadership behaviours within delivering value for customers including patients by understanding and meeting their needs; act with candour and courage; make rapid, disciplined decisions
• Strong stewardship skills
• Ability to work effectively in a matrix organization
• Excellent understanding of core systems, tools, and metrics
•English on proficiency level
Education & Experience
• The position requires either a Medical Degree (preferred) or a PhD/PharmaD in life science.
• Relevant prior experience can replace the above-mentioned degree requirements.
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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:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
02/11/2025
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