Director of Medical Writing | Global Pharmaceutical Company | On-Site Boston
Director ofMedical Writing – Boston, MA
Our client, a leading-pharmaceutical company, is currently seeking a Director of Medical Writing to join their amazing team that truly functions more like a career family!This is an opportunity to join a dynamic work environment in a highly-visible role, working with a group of passionate professionals driven by patient-focused therapeutic treatments. This person will have a hands-on approach with a willingness to not only manage, but also perform medical writing duties as needed and will have senior-level industry experience with Clinical Medical Writing and a passion for leading a great team! Incredible compensation, equity and benefits package offered. This role is in Boston and we will relocate the right candidate- there is an ability to work from home 2-3 days per week, but the Director must live in Boston.
The Director of Medical Writing will be responsible for leading and managing a team of writers preparing high-quality clinical regulatory documents. Key responsibilities include:
- Advising teams on the content and presentation of clinical regulatory documents
- Participating as a member of team involved in defining the direction of the clinical development program or regulatory strategy
- Contributing to SOP and template development and maintenance
- Participating in developing and implementing processes and templates to ensure efficient preparation of high quality medical writing deliverables
- Overseeing hiring of staff; coaching and performance management
- Planning, writing, editing, and formatting key documents, including clinical protocols, IBs, clinical study reports, integrated safety and efficacy summaries and related documents.
- 7-10+ years of relevant experience required, advanced degree preferred
- Experience authoring clinical regulatory documents
- Experience in a leadership role in complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA)
- Experience managing direct and indirect reports, including medical writing contractors
- Ability to plan, manage, and optimize resources
- Strong leadership and influencing skills
- Attention to detail
This role will provideincredible career growth at a veryinnovativecompany. INCREDIBLE BENEFITS, EQUITY package.
If you are interested in this position, please send your resume to Katie email@example.com.