We are seeking a Senior Director/Director, Medical & Scientific Writing to support our publication process across all programs. This role requires a strategic thinker with a variety of experience in clinical development and medical affairs with deep insight into how these diverse functions contribute to the success of the company.
This position will report to the Vice President, Medical Affairs and will be located in the Waltham, MA office.
- Communicate through multiple internal channels to ensure global reach and understanding of shared scientific/medical information
- Implement the strategic and tactical Global Publication Plan and Scientific Communication Plan, including the engagement of external expert advisors.
- Ensure good publication practices among authors and internal stakeholders to ensure that all publications are being authored, written, and reviewed according to GPP3/ICMJE guidelines and are consistent with Deciphera’s publication policy
- Collaborate with internal clinical and medical team and external investigators and KOLs to drive the drafting and writing of clinical abstracts, presentations, manuscripts and reviews
- Communicate complex medical information in a succinct way
- Prepare scientific, clinical and medical training materials and eLearning content according to the needs of the audience
- Develop collaborative relationships with KOLs
- Bachelor's degree with 10+ years; or MS with 8+ years; or PhD with 5+ years of relevant career experience.
- Must have at least 10 years in technical/scientific writing with 5 years of experience in managing scientific documents (e.g., nonclinical, clinical, regulatory, etc.) including publishing and submissions.
- Strong knowledge of FDA/ICH guidelines and GCP.
- Provide leadership and management for complex documentation projects
- Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management
- Excellent writing skills
- Experience in coordination and prioritization of multiple projects in a fast-paced environment.
- Must have proven ability to understand and interpret clinical trial output; summarize complex results and present them in a clear, concise, and scientifically accurate manner to various end users.
- Fluent in English (oral and written communication) skills.
- Background in oncology drug development is preferred.
- Awareness of pharmaceutical industry needs beyond clinical development and medical affairs.