Medical Writer

Summary

Join Arvinas, a clinical-stage biotechnology company, as their Director, Medical Writer. This leadership role involves developing and managing medical writing deliverables supporting the clinical regulatory writing portfolio. You will lead a team, manage documentation, ensure consistency, and mentor writing resources. The position requires strong communication, project management, and medical writing expertise, particularly in oncology or rare diseases. The role offers a competitive compensation package and comprehensive benefits, and can be remote, hybrid, or on-site in New Haven, CT. Arvinas values innovation and a collaborative work environment. This is an opportunity to influence medical writing best practices and contribute to a forward-thinking team.

Requirements

• 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
• Bachelor’s Degree Required

Responsibilities

• 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

Preferred Qualifications

Advanced Degree

Benefits

• Competitive package of base and incentive compensation
• Comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families
• Group medical, vision and dental coverage
• Group and supplemental life insurance
• Remote work, hybrid work options