Job Description
Target Pay Rate: 100-153.33/hr **salary will be commensurate with experience
Position Summary: The Medical Writer is responsible for development and management of medical writing deliverables that support the clinical regulatory writing portfolio and is capable of working independently to achieve goals. The Medical Writer is responsible for a Therapeutic Area, managing all documentation and ensuring consistency as required in order to execute on the writing deliverables across the clinical and regulatory portfolio. Serving as a link among key functions, the Medical Writer ensures that critical information is communicated with clarity, precision, and accessibility. This individual works cross-functionally to prepare and update documents, including clinical protocols, annual reports, Investigator Brochures, abstracts, clinical study reports, manuscripts, and regulatory authority briefing materials, to support product development. The Medical Writer will help develop processes, manage and maintain processes, and assist in development of templates. This role will help influence Medical Writing best practices. This position reports to the Senior Director of Medical Writing, Clinical Development and can be remote, hybrid, or located at our headquarters in New Haven, CT.
Principal Responsibilities: Key responsibilities of this role include, but are not limited to:
• 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.
• Provide expertise to other medical writers and cross-functional teams regarding medical writing processes, standards, and initiatives.
• 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. • Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
• Define content document prototypes and shells to various cross-functional teams.
• Be recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation.
• Apply in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects.
• Produce high-quality and timely documentation in line with expectations. Interpret and apply knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines.
• Provide input on data analysis planning and interpretation.
• Coordinate quality control review of documents.
• Work collaboratively with colleagues across functions to achieve results.
• Solve complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve.
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.
• Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.
• Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
• Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals.
• Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
• Sense of urgency in performance of duties.
• Interpersonal skills that promote a collaborative and productive team environment.
Education: • Bachelor’s Degree Required, Advanced Degree preferred.
**CO/NY candidates may not be considered
Job Tags
Contract work, Work experience placement, Work at office,