Director, Documentation Lead – Medical Writing

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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Director, Documentation Lead – Medical Writing

Job Description

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