Medical Writing Manager
Posted 1 week ago
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Lead and develop a high-performing team of Medical Writers, overseeing workload distribution and ensuring exceptional performance. Drive quality and delivery excellence in medical writing deliverables, ensuring projects meet scientific and regulatory standards. Represent the department externally and contribute to shaping medical writing strategy and processes.
Responsibilities
- Manage, mentor, and develop Medical Writers for exceptional performance and continuous growth
- Oversee workload distribution, resource planning, and project assignments
- Conduct regular 1:1s, performance reviews, and coaching conversations
- Supervise and review the preparation of a wide range of medical writing deliverables
- Ensure projects are completed on time and to the highest scientific and regulatory standards
- Serve as a senior reviewer and departmental expert for study design, adverse event reporting, and interpretation of statistical data
- Stay current with ICH, FDA, and global regulatory guidance
- Deliver compelling capabilities presentations to prospective clients
- Collaborate with Business Development and Contracts teams to support bids, budgets, and proposals
- Contribute to the development, evaluation, and improvement of SOPs and work practices
- Lead or support internal training programs for new and existing staff
Requirements
- Bachelor's degree in a life science field
- 5+ years of relevant regulatory writing experience
- 2+ years in medical writing within pharma/CRO
- 1+ year of leadership responsibility
- Exceptional writing, editorial, and data interpretation skills
- Strong project management ability (forecasting, timelines, resource allocation)
- Excellent communication and presentation skills (client-facing settings)
- Ability to manage complexity, multitask, and work in a fast-paced environment
Qualifications
- Bachelor's degree in a life science field (advanced degree-PharmD, PhD, MSc-preferred)
- 5+ years of relevant regulatory writing experience, including at least 2 years in medical writing within pharma/CRO and 1+ year of leadership responsibility.
Nice to Have
- Advanced degree (PharmD, PhD, MSc)
Benefits
About Thermo Fisher Scientific
Thermo Fisher Scientific is a company that enables customers to make the world healthier, cleaner and safer, providing solutions for some of the world's toughest challenges, across various industries including pharmaceutical, biotechnology, clinical labs, academia, government, environmental, and foo...