Director, Documentation Lead – Medical Writing
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.
A Documentation Lead in Medical Writing is responsible for development and management of medical writing deliverables that support the R&D portfolio and is capable of working independently to achieve goals. The Director, Documentation Lead is responsible for leading a program or TA, or department while managing documents for global submissions, ensuring consistency, assigning resources, and managing/mentoring writing resources as required in order to execute on the writing deliverables across the R&D portfolio.
Serving as a link among key functions, the Director, Documentation Lead 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, Documentation Lead will help develop processes, manage and maintain processes, assist in development of templates, and train 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 Operations and can be remote, hybrid, or located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
Leadership
- Serve in a supervisory role as Program/Submission Lead, developing strategic plans and managing projects, in support of regulatory submissions, nonclinical and clinical deliverables.
- 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).
- Interpret and apply knowledge of regulatory/compliance/scientific requirements/guidances using own judgment, prior work experience, and broad appreciation of impact on other disciplines.
- Support production of high-quality and timely documentation in line with expectations.
- Is recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation.
- 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.
Medical Writing
- Demonstrate mastery of complex writing assignments (e.g., Phase 3 CSRs, SCS, SCE, regulatory meeting packages, etc.) across therapeutic areas or multiple projects.
- Coordinate and author key regulatory documents ensuring the integration of scientific, medical, and regulatory input from development team members.
- Participate in relevant subteams and ensure effective planning and management of timelines for all components of assigned documents.
- Provide support for MW team and accountability for high quality deliverables.
- Provide input on data analysis planning and interpretation.
- Assist in tracking of deliverables and managing vendors.
- Coordinate quality control review of documents.
Supervising and Maintaining Standards
- Provide guidance for other medical writers and cross-functional teams regarding medical writing processes, standards, and initiatives.
- Supervise medical writers and contractors.
- Lead or co-lead teams to define content document prototypes and shells.
Qualifications
- Minimum of PhD or advanced academic degree with 10+ years of experience in the research, medical, pharmaceutical, or biotechnology industry.
- Minimum of 3 years in supervisory role leading medical writers.
- 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.
- Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.
- Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
- Sense of urgency in performance of duties.
- 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.
- 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.
- Interpersonal skills that promote a collaborative and productive team environment.
- Arvinas will not be providing VISA sponsorship for this position now or in the future. 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 an 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.
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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