Director, Medical Writer

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC^® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC^® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.

In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and “undruggable” targets, the company has three investigational clinical-stage programs currently enrolling: vepdegestrant for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-102 for the treatment of patients with neurodegenerative disorders, and ARV-393 for the treatment of patients with relapsed/refractory non-Hodgkin Lymphoma and potentially other lymphomas.

In April 2024, Arvinas entered into a transaction with Novartis, including a global license agreement for the development and commercialization of the clinical stage PROTAC^® androgen receptor protein degrader ARV-766 for the treatment of prostate cancer. The transaction closed in May 2024.

#TeamArvinas is made up of approximately 450 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 mission – to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC® protein degradation platform. We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. But don’t just take our word for it – learn more about life at Arvinas and what employees have to say.

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 leading a team and/or Therapeutic Area, managing all documentation, ensuring consistency, assigning resources, and managing/mentoring writing resources as required in order to execute on the writing deliverables across the clinical and regulatory portfolio.

Serving as a link among key functions, the Director, 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 Director, Medical Writer will help develop processes, manage and maintain processes, assist in development of templates, and train of new staff. This is a unique opportunity to influence Medical Writing best practices and help create an efficient and forward-thinking Medical Writing team.

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 in a supervisory role as Program/Submission Lead, 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 guidance for other medical writers and cross-functional teams regarding medical writing processes, standards, and initiatives.
• Provide support for Medical Writing team and accountability for high quality 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., 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 document 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.
• 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 3 years in supervisory role leading a 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.
• 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.
• Arvinas will not be providing VISA sponsorship for this position. You must have the ability to work without a need for a current or future VISA sponsorship.
• The duties of this role are generally conducted in a home office environment. Employees must be able, with or without accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Education

• Bachelor’s Degree Required, Advanced Degree preferred.

#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