Associate Director, Medical Writing

Location: Emeryville, CA
Department: Clinical Development - Fintepla

Position Summary

The Associate Director of Medical Writing will be responsible for clinical and regulatory writing deliverables. This individual will collaborate with and provide direction to members of cross-functional teams in preparing high-quality documents such as protocols and protocol amendments, Investigator’s Brochures, clinical study reports (CSRs), Common Technical Document (CTD) summaries, integrated summaries (ISS and ISE), and other related clinical and regulatory documents within agreed-upon timelines. The Associate Director, Medical Writing will report to the Director, Medical Writing and is expected to provide leadership within Medical Writing.

Responsibilities

  • Independently prepares, edits, and finalizes complex clinical and regulatory documents supporting clinical studies and reporting of clinical study and clinical program results for regulatory submissions
  • Serves as medical writing representative on cross-functional study teams and provides guidance on document strategy and content, timelines, and resource needs
  • May serve as lead writer for marketing application submissions, providing medical writing expertise and input on strategy and execution
  • Manages the document development process from start to finish (ie, generation of a draft document to a final approved version), which may include, but is not limited to: timeline development, shell creation, draft authoring, editing, reference retrieval, generating bibliographies, and managing various processes (eg, reviews, quality checks, quality audits, formatting, publishing)
  • Collaborates with cross-functional team to interpret study results and ensure results and statistical interpretations are accurately and clearly reflected in documents
  • Organizes, conducts, and leads cross-functional document development meetings, such as kick-off meetings and comment resolution meetings conducted to ensure conflicting and/or ambiguous comments are clarified and appropriately addressed
  • Works closely with the study team to reach consensus on and complete documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments
  • Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
  • Performs editorial reviews of documents or sections of documents prepared by other writers (internal or external) or subject matter experts and ensures the quality of documents and consistency of documents across a program
  • Provides oversight of external consultants for medical writing deliverables
  • Assists with the development of department procedures and initiatives and suggests or identifies changes, modifications, and improvements to current document preparation processes and templates to improve quality, efficiency, and productivity

Qualifications 

  • Bachelor's degree or equivalent in medical-related field or life science; post-graduate degree in a scientific or medical field strongly preferred
  • 8+ years of relevant medical writing experience in the biopharmaceutical industry
  • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages of clinical development, with a proven ability to lead cross-functional teams through the authoring process
  • Experience authoring NDA/MAA and IND/CTA submission documents, protocols, clinical study reports, Investigator Brochures, and other regulatory documents
  • Experience as a lead writer for a cross-functional team or program, with the ability to effectively influence, negotiate, and collaborate within a team environment
  • Expert ability to interpret statistical and clinical data and to write and edit complex material with commitment to accuracy, clarity, consistency, and effectiveness
  • Extensive knowledge of federal regulations, Good Clinical Practices, ICH-E3, and applicable US/International regulatory processes related to document preparation and production (including eCTD); demonstrated ability to interpret and apply these guidelines to document writing
  • Demonstrated ability to monitor and communicate progress against milestones and escalate complex issues appropriately
  • Able to manage multiple projects and adapt quickly to new situations and new project demands.

Other Skills

  • Exceptional written communication, interpersonal, and project management skills
  • Superior attention to details with commitment to accuracy
  • Ability to work independently with minimal to no supervision, multi-task, work effectively under pressure, and adapt to change as needed
  • Broad knowledge of clinical development and statistics applications to the presentation of clinical data
  • Establishes and maintains professional and productive working relationships with team members
  • Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues
  • Maintains familiarity with current industry practices, regulatory requirements, and guidances that affect medical writing
  • Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)

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