Job Description

Senior Specialist Medical Affairs

This position is under the supervision of an Associate Director and is responsible for operational activities related to study planning, study execution, and the summarization of results from observational research studies and related activities.

Responsibilities and Primary Activities

• Coordinates the end-to-end process for executing observational or non-interventional research studies in compliance with Good Pharmacoepidemiology Practice and research-related standard operating procedures (SOPs).

• Collaborates with colleagues across V&I to support the lead scientists in overall operational support for study conduct.

• Provides study-level management support, which includes the execution of appropriate service for approved proposals/scopes of work (including the review of requests for information/proposal, draft scope of work, where applicable), confidentiality and consultant agreements, and subsequent amendments/change orders.

• Participates in protocol and interim/final report preparation and literature review abstraction and summarization.

• Coordinates the review and finalization of all vendor documents, such as safety management, data management, communication, project management, and validation plans.

• Tracks study timelines and deliverables and follows up on action items.

• Collaborates extensively and troubleshoots issues by providing potential resolutions (when necessary) with internal and external partners, ensuring timely study management and execution.

• Assists in tracking study milestones and timelines.

• Liaises with outsourced vendors and cross-functional teams to communicate and oversee project status and/or needs.

• Provides supplier oversight to ensure alignment with all SOPs and other internal/external requirements.

• Participates in quality-control assessments and ensures integrity of study data for reports and publications.

• Understands, coordinates and documents adherence to internal, external and regulatory compliance requirements.

• Utilizes, manages and maintains document repositories and internal/external systems.

• Provides operational support for due-diligence checks, site contract and budget review/approval, informed consent, study registration, information technology (IT) and/or privacy assessments, vendor qualification, adverse-event reporting and reconciliation, and publication submissions.

• Manages poster and publication development, including formatting, medical writing, figure/data content development, co-author review, internal-review process, and journal submissions.

Required Qualifications, Skills and Experience

• Bachelor's degree in Nursing, Biology, Public Health or health-related or science discipline.

• 2+ years of work experience within clinical/observational research or equivalent experience.

• Knowledge of epidemiologic or outcomes research.

• Advance English (written and spoken).

• Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders.

• Strong project management and prioritization skills.

• Understanding of digital innovation

• Ability to work independently and collaboratively.

Preferred

• Master's degree or specialization in public health (or closely related discipline, such as health administration or biological sciences).

• Project Management Professional or Certified Associate Project Management certification.

Required Skills:

Advisory Board Development, Anti-Bribery and Corruption (ABC), Business Administration, Business Systems, Clinical Trial Planning, Continuing Medical Education (CME), Data Analysis, Due Diligence, Epidemiology, Financial Advising, Medical Affairs, Medical Knowledge, Medical Marketing Strategy, Medical Policy Development, Medical Reporting, Medical Training, Medical Writing, Meeting Minutes, Multiple Therapeutic Areas, Pharmaceutical Medical Affairs, Pharmacovigilance, Research Reporting, Scientific Communications, Stakeholder Engagement, Strategic Thinking

Preferred Skills:

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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:

Project Temps (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

04/24/2026

*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.