Responsibilities:
- Serve as functional expert in Medical Review for assigned region/products; integrate process/technology efficiencies across disease areas.
- Perform timely, accurate scientific/medical review of promotional and non-promotional medical affairs materials for US and Global markets in line with policies, practice standards, and regulatory guidelines.
- Ensure materials convey accurate, correct, balanced medical/scientific messages.
- Partner with Head of Medical Review to deliver high-quality, balanced, timely medical/scientific deliverables upon request.
- Provide advanced medical information/clinical expertise to internal stakeholders (medical affairs strategy, R&D product teams, commercial brand teams).
- Support Medical Review needs for other brands/pipeline products as needed.
- Support medical review process training, content substantiation/reference validation, medical affairs booth and scientific meeting support, and GMSTO meeting subject-matter expertise.
- Lead procedural guideline/SOP development and maintain departmental guidance; coach/mentor team members.
Minimum Qualifications:
- PharmD/Doctorate (5+ yrs) OR Masterโs (7+ yrs) OR Bachelorโs (8+ yrs) plus pharma/biotech experience.
- 5+ years healthcare/related experience, including 3+ years medical review in pharma.
- Excellent written/oral communication.
- Advanced PC skills (MS Word, Excel, PowerPoint, SharePoint).
- Experience managing budgets vs targets.
- Oncology experience strongly preferred.
- Strong understanding of clinical development and product lifecycle management; cross-functional experience.