Job Title: Senior Medical Reviewer (Promotional Review Lead)
Employment Type: Part-Time Contract (20-25 hours/week)
Location: Remote (U.S. East Coast time zone alignment required)
Contract Duration: Through End of 2026
(High likelihood of extension into 2027 based on performance and business needs)
Schedule & Availability Requirements
- Total Commitment: Approximately 20-25 hours per week.
- Mandatory Collaboration Hours: Must be available every Tuesday and Thursday from 10:00 AM to 2:00 PM Eastern Time (ET) to participate live in cross-functional MLR review meetings.
- Flexible Hours: The remaining 12-17 weekly hours can be completed independently on a schedule managed by the contractor, provided project timelines and turnaround expectations are consistently met.
Position Overview
We are seeking an experienced
Senior Medical Reviewer to join our Medical Affairs team on a flexible, part-time basis. This role is responsible for driving and managing all Medical Review activities for an assigned indication within the
Psychiatry therapeutic area (focusing primarily on Bipolar I Disorder, as well as general psychiatric conditions).
As the Medical Review Lead for this indication, you will own the review process end-to-end, acting as a trusted scientific partner to Commercial teams. You will ensure that all promotional materials are scientifically accurate, clinically sound, compliant with applicable standards, and fully aligned with medical strategy.
Key Responsibilities
- Ownership of Indication: Function as the dedicated Medical Review lead for an assigned psychiatric product indication, taking full accountability for the scientific review of associated materials.
- Promotional Review: Critically evaluate promotional, non-promotional, scientific, and educational materials for medical accuracy, appropriate data interpretation, scientific rigor, and compliance with regulatory guidelines.
- MLR Committee Participation: Represent Medical Affairs during recurring Medical, Legal, and Regulatory (MLR) review collaboration meetings. Active participation is required during mandatory window hours every Tuesday and Thursday from 10:00 AM to 2:00 PM Eastern Time.
- Cross-Functional Collaboration: Partner effectively with Commercial, Marketing, Legal, and Regulatory colleagues to review and refine materials through the formal approval lifecycle.
- Independent Workload Management: Autonomously manage review queues, prioritize deliverables, and maintain project timelines outside of scheduled committee meetings with minimal day-to-day guidance.
- System Management: Navigate electronic material review workflows and routing systems to process reviews and clear comments efficiently.
Qualifications & Requirements
Basic Qualifications
- Education: Advanced scientific degree (MD, PhD, PharmD, MS, or equivalent science/clinical background would be preferred).
- Industry Experience: Prior pharmaceutical or biotech industry experience is required. Candidates without pharmaceutical industry experience will not be considered.
- Scientific Expertise: Proven ability to analyze, interpret, and communicate complex clinical and scientific data effectively.
- Organizational Knowledge: Deep understanding of Medical Affairs structures, Commercial team functions, and the cross-functional dynamics of the promotional review process.
- Workstyle: High level of autonomy, sound scientific judgment, rigorous attention to detail, and excellent written/verbal communication skills.
- Medical Review Experience: Direct experience performing Medical Review or Promotional Review (MLR) in a pharmaceutical setting is strongly preferred.
- Therapeutic Area Experience: Experience in Psychiatry (e.g., Bipolar I Disorder, Major Depressive Disorder, Schizophrenia, Anxiety) or related Central Nervous System (CNS) therapeutic areas would be preferred.
- Platform Experience: Hands-on experience with Veeva PromoMats or similar electronic promotional review software.
- Corporate Systems: Prior experience within large enterprise pharmaceutical environments, systems, and compliance frameworks.
- Backgrounds Considered: Medical Science Liaisons (MSLs), Medical Directors, Pharmacovigilance professionals with strong clinical review competencies, or semi-retired industry professionals looking for a part-time engagement.
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