Job Description
Senior Specialist, Medical Affairs
At our company, we aspire to be the premier research-intensive biopharmaceutical company. Were at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and use the power of leading-edge science to save and improve lives around the world.
Position Purpose
The Senior Specialist, Medical Affairs is a strategic scientific partner and an integral member of the cross-functional medical team, responsible for the development and execution of the medical strategy for assigned products and therapy areas within General Specialty Medicine. Operating as an individual contributor, the role ensures alignment of the Medical Affairs Plan, drives evidence generation, supports clinical-practice transformation, and provides medical and scientific leadership to internal and external stakeholders. The role additionally brings medical and scientific expertise into New Product Planning (NPP).
Key Responsibilities
1 Scientific Medical Expertise
- Maintain deep clinical and scientific expertise in the assigned therapy area, products and the evolving scientific landscape.
- Serve as the subject-matter expert and trusted scientific counterpart for internal and external stakeholders.
- Provide expert medical / scientific advice, respond to medical queries, and develop medical information and clinical expert reviews.
2 Medical Strategy Cross-Functional Leadership
- Lead and contribute to the Therapy-Area / Field Medical Strategic Plan, ensuring alignment with broader Medical Affairs objectives.
- Partner cross-functionally with Clinical Development, Regulatory, Pharmacovigilance and Market Access to develop and execute integrated medical plans, in line with compliance and medical-governance standards.
- Provide therapeutic rationale and scientific support for regulatory submissions, SEC (Subject Expert Committee) presentations and medical launch-readiness.
3 Evidence Generation Clinical Research
- Provide medical and scientific expertise into the design of Phase 3b / Phase IV studies, RWE, registries, HEOR, epidemiological surveys and Investigator-Initiated Studies (IIS).
- Develop insight-driven medical plans; identify knowledge, practice and data gaps and recommend evidence-generation initiatives.
4 KOL / External Stakeholder Engagement
- Identify and map Key Opinion Leaders (KOLs); build credible peer-to-peer scientific relationships.
- Conduct scientific engagement with KOLs through advisory boards, scientific workshops, congresses and medical-education programs; gather and translate scientific insights into medical strategy.
5 Medical Education Scientific Communication
- Deliver high-quality scientific presentations and medical-education programs to healthcare professionals and internal teams.
- Support non-promotional scientific meetings as speaker / facilitator, conduct speaker briefings, and deliver scientific and disease-area training to internal cross-functional colleagues.
6 Medical Review Compliance
- Serve as medical reviewer / signatory for promotional and non-promotional materials, ensuring scientific accuracy, fair balance and full compliance with internal SOPs and applicable regulations.
7 Team Support Resource Management
- Support capability-building and scientific mentoring within the medical team; support planning and management of the medical-affairs budget for the assigned portfolio.
8 New Product Planning (NPP) Pre-Launch Readiness
- Serve as the medical and scientific expert within cross-functional New Product Planning teams, bringing early clinical, scientific and patient insights into pipeline and evidence-planning decisions.
- Contribute to indication sequencing and lifecycle medical strategy, ensuring scientific evidence and unmet-need insights guide program development.
- Provide medical input to proof-of-concept and pivotal trial design (endpoints, comparators, patient journey and evidence-generation strategy).
- Support pre-launch and launch-readiness activities – Medical Value Narratives, scientific training materials, CME / scientific decks and KOL advisory boards to advance understanding of the disease area.
- Partner cross-functionally with NPP, Regulatory, GCTO and Market Access to ensure early medical and scientific alignment on evidence and unmet-need requirements.
Qualifications Experience
Education
MBBS with MD (Pharmacology / Internal Medicine) preferred.
Experience
Typically 5–6 years in pharmaceutical Medical Affairs, Clinical Research or Scientific Affairs (individual-contributor).
Therapy-Area Exposure Relevant experience across General Specialty Medicine; cardiometabolic, pulmonology, immunology or specialty-care exposure advantageous.
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 bringing forward medicines and vaccines for many of the worlds 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 us—and start making your impact today.
Required Skills:
Advisory Board Development, Clinical Medicine, Clinical Trial Planning, Continuing Medical Education (CME), Data Analysis, Internal Medicine, Medical Billing, Medical Ethics, Medical Governance, Medical Knowledge, Medical Law, Medical Marketing Strategy, Medical Offices, Medical Policy Development, Medical Review, Medical Teaching, Medical Training, Medical Writing, Multiple Therapeutic Areas, Pharmaceutical Medical Affairs, Pharmacovigilance, Scientific Communications, Stakeholder Engagement, Strategic Thinking
Preferred Skills:
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Current Contingent Workers applyHERE
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:
08/23/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.
Requisition ID: R410826