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    Director, Documentation Lead – Medical Writing

    Arvinas
    2+ years
    Not Disclosed
    India
    10 Sept. 7, 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

    About Arvinas

    Arvinas is a cutting-edge biotechnology company dedicated to transforming the lives of patients with severe and life-threatening diseases through the discovery, development, and commercialization of therapies that target disease-causing proteins for degradation. Leveraging our proprietary PROTAC® Discovery Engine, we engineer proteolysis-targeting chimeras (PROTAC® targeted protein degraders) to utilize the body’s natural protein disposal system, effectively removing harmful proteins and advancing patient care.

    Our pipeline includes several promising investigational drugs, such as:

    • Vepdegestrant: Targeting the estrogen receptor for patients with ER+/HER2- locally advanced or metastatic breast cancer.
    • ARV-102: Targeting LRRK2 for neurodegenerative disorders.
    • ARV-393: Targeting BCL6 for relapsed/refractory non-Hodgkin lymphoma.

    In April 2024, Arvinas entered a significant agreement with Novartis, securing a global license for the clinical-stage PROTAC® androgen receptor protein degrader ARV-766, aimed at treating prostate cancer. This deal was finalized in May 2024.

    Our team, known as #TeamArvinas, comprises about 450 dedicated professionals who thrive in an environment that values innovation, creativity, and community engagement. We are driven by our mission to enhance the lives of patients with serious diseases using our groundbreaking PROTAC® platform. We invite you to explore more about life at Arvinas and hear directly from our employees.

    Position Summary

    Arvinas is seeking a Director, Documentation Lead in Medical Writing to manage and develop medical writing deliverables for our R&D portfolio. This role involves overseeing global submissions, ensuring document consistency, assigning resources, and mentoring writing staff. You will act as a liaison among key functions, preparing and updating critical documents such as clinical protocols, annual reports, Investigator Brochures, abstracts, clinical study reports, and regulatory authority briefing materials.

    This role reports to the Senior Director of Medical Writing, Clinical Operations, and can be performed remotely, in a hybrid setting, or at our headquarters in New Haven, CT.

    Principal Responsibilities

    Leadership:

    • Lead as Program/Submission Lead, developing strategic plans and managing projects for regulatory submissions and clinical deliverables.
    • Utilize extensive knowledge of regulatory medical writing and therapeutic areas to support pipeline projects.
    • Represent the medical writing function in cross-functional teams and apply regulatory/compliance/scientific requirements.
    • Ensure timely and high-quality documentation production, and solve complex medical writing challenges.

    Medical Writing:

    • Master complex writing tasks, including Phase 3 CSRs, SCS, SCE, and regulatory meeting packages.
    • Coordinate and author key regulatory documents, integrating scientific, medical, and regulatory insights.
    • Manage timelines and deliverables for all assigned documents, and oversee quality control reviews.

    Supervising and Maintaining Standards:

    • Provide guidance on medical writing processes and standards.
    • Supervise and mentor medical writers and contractors.
    • Lead the development of document prototypes and templates.

    Qualifications

    • 10+ years in the research, medical, pharmaceutical, or biotechnology industry.
    • Minimum of 3 years in a supervisory role leading medical writers.
    • At least 5 years of experience preparing regulated documents in the pharmaceutical or biotech industry, with a focus on oncology or rare diseases.
    • Excellent oral and written communication, presentation, and project management skills.
    • Ability to thrive in a fast-paced, entrepreneurial environment with a strong sense of urgency.
    • In-depth 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, document management systems, and SharePoint.
    • Strong interpersonal skills to foster a collaborative team environment.

    Education

    • Bachelor’s Degree required; Advanced Degree preferred.

    Additional Information

    • This role does not offer VISA sponsorship now or in the future.
    • The position is generally performed in a home office environment. Candidates must be able to use a computer, communicate via phone and electronic messaging, and collaborate effectively.

    Benefits

    Arvinas offers a competitive base salary, incentive compensation, and a comprehensive benefits package including medical, vision, dental coverage, life insurance, and more. To learn more about Arvinas and explore our opportunities, please visit www.arvinas.com.

    Arvinas is an Equal Opportunity Employer.

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