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    Director, Documentation Lead – Medical Writing

    Arvinas
    3-10 years
    Not Disclosed
    Remote
    10 Sept. 5, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Director, Documentation Lead - Medical Writing

    Location: Remote, Hybrid, or New Haven, CT Headquarters

    Company Overview: Arvinas is a pioneering clinical-stage biotechnology firm committed to transforming patient care by developing groundbreaking therapies that target and degrade disease-causing proteins. Leveraging our proprietary PROTAC® Discovery Engine platform, we create targeted protein degraders designed to harness the body’s natural protein disposal system. Our innovative approach is driving forward multiple investigational drugs, including vepdegestrant for ER+/HER2- breast cancer, ARV-102 for neurodegenerative disorders, and ARV-393 for non-Hodgkin lymphoma. Recently, we entered into a significant global license agreement with Novartis for ARV-766, a PROTAC® androgen receptor protein degrader for prostate cancer.

    Position Summary: The Director, Documentation Lead is a key leadership role responsible for overseeing and managing medical writing deliverables across Arvinas' R&D portfolio. This role involves leading global submissions, ensuring document consistency, and mentoring writing resources. As a critical link among functions, the Director will ensure the precise and clear communication of essential information, prepare and update key documents, and influence best practices in medical writing.

    Principal Responsibilities:

    Leadership:

    • Lead as Program/Submission Lead, developing strategic plans and managing projects for regulatory submissions and clinical/nonclinical deliverables.
    • Apply extensive regulatory medical writing knowledge and therapeutic area expertise to support pipeline projects.
    • Represent the medical writing function in cross-functional teams and interpret regulatory requirements and scientific guidelines.
    • Ensure the production of high-quality, timely documentation in alignment with expectations.
    • Serve as a scientific contributor and subject matter expert in regulatory clinical documentation preparation.
    • Collaborate effectively with colleagues across functions to achieve project goals.
    • Address and resolve complex medical writing challenges, including ambiguous situations and the need for innovative solutions.

    Medical Writing:

    • Master complex writing assignments such as Phase 3 Clinical Study Reports (CSRs), regulatory meeting packages, and other key documents.
    • Coordinate and author essential regulatory documents, integrating scientific, medical, and regulatory input.
    • Participate in subteams and manage timelines for all document components.
    • Support the medical writing team and ensure high-quality deliverables.
    • Contribute to data analysis planning and interpretation.
    • Track deliverables, manage vendors, and coordinate quality control reviews.

    Supervising and Maintaining Standards:

    • Provide guidance on medical writing processes, standards, and initiatives.
    • Supervise medical writers and contractors.
    • Lead teams in defining document prototypes and standards.

    Qualifications:

    • 10+ years of experience in the research, medical, pharmaceutical, or biotechnology industry.
    • At least 3 years in a supervisory role managing medical writers.
    • Minimum of 5 years of experience in medical writing, particularly in oncology or rare diseases.
    • Exceptional oral and written communication skills, including presentation abilities.
    • Strong project management skills and ability to function effectively in a fast-paced environment.
    • Good understanding of global drug development and regulatory submission requirements.
    • Proven writing skills evidenced by high-quality regulatory documentation or peer-reviewed publications.
    • Proficiency in Microsoft Office, Adobe Acrobat, and document management systems; familiarity with SharePoint and structured content management is a plus.
    • Excellent interpersonal skills for fostering a collaborative team environment.

    Education:

    • Bachelor’s Degree required; Advanced Degree preferred.

    Additional Information:

    • Arvinas does not provide VISA sponsorship for this position now or in the future.
    • The role is typically conducted in a home office environment, with responsibilities including computer use, communication via phone/video/electronic messaging, problem-solving, and collaboration.
    • Arvinas offers a competitive compensation package and a comprehensive benefits program, including medical, vision, and dental coverage, life insurance, and more.

    For more information about Arvinas and our exciting work, visit www.arvinas.com.

    Arvinas is an Equal Opportunity Employer.

    #LI-Remote

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