This is a pharmaceutical company that specializes in developing innovative therapeutics to treat cancer.
Director, Medical Writing - JO#2102-5531
Therapeutic Area: Cancer
The Director, Medical Writing will lead all medical writing activities, both internal and external, including researching, writing, and editing of clinical study reports, protocols, Investigator’s Brochures, INDs, CTAs and global regulatory submission documents.
Essential Duties and Responsibilities
- Authors TOI documents submitted to Regulatory Authorities (e.g., FDA and EMA), including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections of Common Technical Documents (CTDs) in support of worldwide regulatory submissions.
- Knowledgeable of regulatory requirements regarding content for various clinical/regulatory documents and can apply their knowledge to the development of submission documents.
- Ensures all clinical/regulatory documents are produced with high-quality and adhere to global regulations and internal guidelines, styles, and processes.
- Working knowledge of publishing standards for FDA and MAA.
- Coordinates medical writing with other departments, including Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory Affairs, and other groups.
- Collaborates with Product Development Teams and Clinical Development to ensure alignment with program objectives.
- Supports clinical project teams, representing Medical Writing and takes responsibility for timely and accurate MW deliverables. Negotiates timelines as necessary.
- Manages Medical Writers on assigned programs, both internal and external.
- Mentors junior Medical Writers.
- Assists with resource planning for Medical Writing deliverables.
- Participates in Global Medical Writing initiatives on clinical development cross-functional teams.
- Participates in the development of the operational standards for the medical writing activities (e.g., style guidelines, templates, and QC, etc.).
- Drives operational excellence of medical writing standards, processes, systems, and tools.
Qualifications (Education & Experience)
- BA/BS in Life Science (advanced degree strongly preferred).
- 8-plus years pharmaceutical/biotechnology experience related to clinical research report writing. Oncology experience required.
- Demonstrated expertise in writing/developing clinical documents in support of global regulatory submissions.
- Ability to interpret and organize scientific and clinical data.
- Leadership role in complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA).
- Supervisory experience.
- Experience partnering and managing CRO relationships and other external resources.
- Excellent communication, planning, and organizational skills.
- Ability to inspire, to lead-by-example, and ability to motivate the team to seek solutions to get results.
- Ability to plan, manage, and optimize resources.
Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs and Clinical Operations professionals in life sciences companies in the United States and around the world.
TriNet Pharma has identified and placed Medical Science Liaisons, Clinical Trial Liaisons, and director-level and executive-level professionals across multiple therapeutic areas. The company has a performance-based culture built upon trust, leadership, expertise, and accountability, which have allowed it to enjoy year-over-year growth.
Learn more at www.trinetpharma.com.