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Open Positions: Director, Medical Writer

Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes two clinical-stage programs: ARV-110, which is being developed as a potential treatment for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.

#TeamArvinas is made up of more than 200 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.

Position Summary

The Director, 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 Director, Medical Writer is responsible for managing and coordinating other medical writers and/or external medical writing vendors 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. S/he 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 Director, Medical Writer will manage and maintain processes to track the development of documents and templates, as well as training of new staff.

This position reports to the Executive Medical Director, 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:

  • Provide guidance for 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.
  • Serve in a supervisory role as LeadWriter, to be able to lead other writers, including developing strategies/ plans and managing projects, to complete multiple documents for regulatory submissions and clinical deliverables.
  • Provide support for MW team and accountability for high quality deliverables.
  • Develop resourcing plan to enable full MW support across all deliverables and meet organizational needs.
  • Demonstrate mastery of complex writing assignments (e.g., Phase 3 CSRs, SCS, SCE, 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.
  • Lead or co-lead teams to define content and data displays for CSR prototypes and shells.
  • Is 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. Represent functional area in cross-functional team (either internally or externally).
  • 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.
  • May perform quality control (QC) review (e.g., QC in-text tables against statistical tables, verify titles in standard table of contents, ).
  • 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

  • Minimum of Bachelor’s degree and 10+years of experience in the research, medical, pharmaceutical, or biotechnology industry.
  • Minimum of 5 years in supervisory role leading medical writing team
  • Minimum of 5 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry, with focus in oncology or rare diseases.
  • Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, Investigator’s Brochure, clinical sections of IND) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
  • 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

  • Bachelors Degree required

#LI-Remote

Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com

Arvinas is an Equal Opportunity employer

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