Associate Director, Global & US Medical Review, Oncology
Takeda
June 30, 2026
Remote friendly (Boston, MA)
United States
$169,400 - $266,200 USD yearly
Medical Affairs
About the Role
- Serve as a functional expert in Medical Review for assigned region/products; align and integrate process/technology efficiencies across disease areas for Global Medical Affairs Oncology.
- Perform timely, accurate scientific/medical review of promotional and non-promotional materials for US and global markets per policies, 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 information for assigned products upon internal request.
- Provide advanced medical/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.
How You Will Contribute
- Provide advanced medical/scientific review; provide project management support as needed.
- Review promotional content with applicable US regulatory codes (ABPI/EFPIA/EMEA optional but preferred).
- Develop/deliver Medical Review and MLR process training; ensure compliance.
- Verify substantiation: proper citations, reference validity, and appropriate context vs product claims.
- Develop booth content; support product booths at scientific meetings; participate in booth/congress activities.
- Serve as subject matter expert on GMSTO meetings.
- Design internal communication plans to share metrics; lead SOPs/procedural guidelines; coach/mentor team and trainees.
Minimum Requirements/Qualifications
- PharmD/Doctorate (5+ yrs) OR MS (7+ yrs) OR BS (8+ yrs) in scientific discipline + pharma/biotech experience.
- 5+ yrs healthcare/related experience; 3+ yrs medical review in pharma.
- Excellent written/oral communication; advanced MS Word/Excel/PowerPoint/SharePoint.
- Experience managing budgets; oncology experience strongly preferred.
- Understanding of clinical development and product lifecycle; cross-functional experience.
Preferred Requirements
- PhD/PharmD/equivalent; oncology experience.
Benefits (if applicable per posting)
- Potential eligibility for medical/dental/vision, 401(k), incentives, disability/life insurance, tuition reimbursement, paid time off, and up to 80 sick hours and up to 120 hours paid vacation for new hires.
Location/Work Type
- Hybrid; Boston, MA; Full-time.
- Serve as a functional expert in Medical Review for assigned region/products; align and integrate process/technology efficiencies across disease areas for Global Medical Affairs Oncology.
- Perform timely, accurate scientific/medical review of promotional and non-promotional materials for US and global markets per policies, 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 information for assigned products upon internal request.
- Provide advanced medical/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.
How You Will Contribute
- Provide advanced medical/scientific review; provide project management support as needed.
- Review promotional content with applicable US regulatory codes (ABPI/EFPIA/EMEA optional but preferred).
- Develop/deliver Medical Review and MLR process training; ensure compliance.
- Verify substantiation: proper citations, reference validity, and appropriate context vs product claims.
- Develop booth content; support product booths at scientific meetings; participate in booth/congress activities.
- Serve as subject matter expert on GMSTO meetings.
- Design internal communication plans to share metrics; lead SOPs/procedural guidelines; coach/mentor team and trainees.
Minimum Requirements/Qualifications
- PharmD/Doctorate (5+ yrs) OR MS (7+ yrs) OR BS (8+ yrs) in scientific discipline + pharma/biotech experience.
- 5+ yrs healthcare/related experience; 3+ yrs medical review in pharma.
- Excellent written/oral communication; advanced MS Word/Excel/PowerPoint/SharePoint.
- Experience managing budgets; oncology experience strongly preferred.
- Understanding of clinical development and product lifecycle; cross-functional experience.
Preferred Requirements
- PhD/PharmD/equivalent; oncology experience.
Benefits (if applicable per posting)
- Potential eligibility for medical/dental/vision, 401(k), incentives, disability/life insurance, tuition reimbursement, paid time off, and up to 80 sick hours and up to 120 hours paid vacation for new hires.
Location/Work Type
- Hybrid; Boston, MA; Full-time.