Senior Medical Writer
Evolvinc Menlo Park, CA
- Posted: over a month ago
This position collaborates with cross-functional teams to develop high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.Responsibilities
- Author, co-author, critically edit, and format clinical regulatory documents including NDAs, protocols and protocol amendments, clinical study reports, Investigator’s Brochures, briefing documents, and other regulatory submissions.
- Interact with document authors, contributors, and reviewers (including members of Biostatistics, Clinical Operations, Clinical Development, Project Management, CMC, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents.
- Manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs.
- Facilitate comment resolution with authors, reviewers, and project teams.
- May serve as the functional area representative on project teams and advise such teams on content, format, and style requirements for documents.
- Participate in the development/refinement of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables.
- Assist in the interviewing, mentoring, and integration of medical writing staff as needed.
- Engage in vendor management and provide guidance as needed for execution of assigned tasks.
- Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines.
- BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
- 3 or more years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience writing clinical study protocols, clinical study reports, Investigator’s Brochures, and the clinical sections of INDs, and NDAs (including ISS and ISE); and understanding of the content of higher-level summary documents.
- Writing experience in a variety of therapeutic areas.
- Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines.
- Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness.
- Successful track record of working on complex clinical/regulatory writing projects.
- Excellent attention to detail, multitasking, prioritization, and flexibility.
- Excellent communication skills with proven ability to interact in a cross-functional environment.
- Understanding of the drug-development process, including R&D processes and objectives of the required documents.
- Familiarity with US and Ex-US regulatory requirements and guidelines for documents; general knowledge of e-CTD requirements with respect to structure, format, and content.
- Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas.
- Proficiency in use of MS Office applications, Adobe CS, electronic document management systems (e.g., Veeva), and templates (e.g., StartingPoint).
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.
- Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision.
- Ability to think strategically, be resourceful, and lead without formal authority.
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AddressMenlo Park, CA
EducationView all jobs at Evolvinc