Senior Manager/Associate Director, Medical Writing
The Senior Manager/Associate Director, Medical Writing will be responsible for writing various clinical and regulatory documents including distribution of work to contract medical writers or agencies as needed. The position’s focus includes protocol development, CSRs, IBs, and regulatory submissions. The successful candidate will work closely with cross-functional teams to ensure the documents are of high quality, are completed on time, and comply with SOPs, ICH/GCP/regulatory guidelines, and eCTD requirements. The Senior Manager/Associate Director, Medical Writing will report to the Director, Medical Writing.
- Manage the writing, editing, or collaborating on development of high quality clinical and regulatory documents (eg, protocols, CSRs, IBs, and regulatory submissions)
- Contribute scientifically and strategically and lead submission-level activities
- Ensure smooth and effective document management from start to finish (ie, from template to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (eg, follow house style guide), and managing various processes (ie, reviews, QC, QA, formatting, document archiving)
- Provide guidance in the analysis, synthesis, and presentation of complex information for scientific presentations
- Formulate key messages from clinical study data
- Contribute to medical writing processes, SOPs, templates and outlines for key documents
- BS, MS, or PhD in a scientific or medical discipline
- 6+ years of experience with medical/regulatory writing
- Experience authoring/editing CSRs and other types of clinical regulatory documents (ie, protocols, IBs, NDA/MAA clinical modules)
- Expert abilities in Microsoft Office Suite, Adobe Acrobat and electronic content management systems
- In-depth understanding of regulatory/ICH guidelines and GCPs, and related standards (ie, CONSORT, ICMJE) and clinical trial transparency requirements (ie, EudraCT, CT.gov)
- Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support
- Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects
Portola Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.