Principal Medical Writer
Responsibilities
- Author clinical study reports, protocols, Investigator’s Brochures, FDA briefing documents, and IND, NDA, and MAA modules.
- Provide input on data output tabular structure and content and participate in data analysis and interpretation.
- Perform formal literature searches, and succinctly summarize scientific content for assigned projects.
- Collaborate cross-functionally by leading comment resolution meetings and
gaining agreement on outstanding comments that require resolution within
documents. - Develop document timelines that align with client expectations of deliverable deadlines.
- Coordinate quality assurance reviews of documents and maintain audit trails of changes.
- Collaborate with clients and PMB staff to resolve complex or unclear situations.
- Ability to self-drive and meet client deadlines independently.
- Propose and participate in continuous improvement initiatives within PMB.
- Work with team to develop standardization of templates, processes, and tools
(SOPs, best practices, templates, style guide). - Assist in training staff.
Requirements
- A life sciences degree, ideally combined with a science Master’s or PhD;
- 10 or more years of medical writing experience from a medical communications or pharma environment across a broad range of projects and therapeutic areas.
- IND/NDA submission experience required.
- Strong understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guideline;
- Excellent communication skills and problem-solving abilities, with positive, client-focused attitude.
- Strong editorial skills and adaptability to client style preferences.
- Extensive onsite and client meeting experience;
- Strong MS Word and formatting skills, project management skills, and a high attention to detail.
- Experience with Accenture/StartingPoint and Synchrogenix template suites preferred.
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