Senior Medical Reviewer

New Bern-Morehead

**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** (8 hours total/week). * **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. For information on benefits, equal opportunity employment, and location-specific applicant notices. Click here: https://spectraforce.com/spectraforce-applicant-disclaimers-contingent/ At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.