Aequor is hiring: Remote Medical Writer in New Haven

Our client is dedicated to advancing comprehensive programs in oncology and neurodegeneration. They are looking for a Contract Medical Writer to join their team on a 5–6-month contract. Typically, hours will vary from 20-40 hours per week.

Responsibilities

• Serve as a Program/Submission expert, to be able to develop strategies/ plans and managing projects, to complete multiple documents for regulatory submissions and clinical deliverables.
• Coordinate and author regulatory documents (e.g. clinical protocols, annual reports, clinical study reports, Investigator’s Brochure), ensuring the coordination and integration of scientific, medical, and regulatory input from development team members.
• Demonstrate mastery of complex writing assignments (e.g., CSRs, protocols, IBs, DSURs, regulatory authority meeting background packages, etc.) across therapeutic areas or multiple projects.
• Define content document prototypes and shells to various cross-functional teams.
• Scientific contributor and subject matter expert in preparation of regulatory clinical documentation.
• Provide input on data analysis planning and interpretation.

Qualifications

• 10+ years of experience in the research, medical, pharmaceutical, or biotechnology industry.
• Minimum of 8+ years of experience as a medical writer, preparing regulated documents in the pharmaceutical and/or biotech industry, with focus in oncology or rare diseases.
• Technical expertise in Microsoft Office, Adobe Acrobat, ability to learn and use document management systems, and familiarity with SharePoint and concepts of structured content management.
• Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.

Education

• Bachelor’s Degree Required, Advanced Degree preferred.