Sr. Manager, Medical Writing

Location: Emeryville, CA
Department: Clinical Development - Fintepla

Position Summary

The Senior Manager, 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 (IBs), clinical study reports (CSRs), Investigational New Drug (IND) and Common Technical Document (CTD) summaries, integrated summaries (Integrated Summary of Efficacy and Integrated Summary of Safety), and other related clinical and regulatory documents within agreed-upon timelines.

Responsibilities

  • Prepares, edits, and finalizes complex clinical and regulatory documents supporting clinical studies and reporting of clinical study and clinical program results for regulatory submissions
  • Manages 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: shell creation, draft authoring, editing, reference retrieval, generating bibliographies, and managing various processes (eg, reviews, quality checks, formatting, publishing)
  • Serves as medical writing representative on cross-functional study teams and provides guidance on document strategy and content, timelines, and resource needs
  • Collaborates with study team to interpret study results and ensure results and statistical interpretations are accurately and clearly reflected in the document
  • Organizes, conducts, and leads cross-functional document development meetings, such as kickoff 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
  • May serve as lead writer for marketing application submissions, providing medical writing expertise and input on strategy and execution
  • Ensures that medical writing deliverables conform to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other relevant regulatory guidelines
  • Assists with the development of department procedures and initiatives
  • May provide oversight of external consultants for medical writing deliverables
  • Other duties as assigned

Qualifications 

  • Bachelor's degree or equivalent in medical-related field or life science; postgraduate degree in a scientific or medical field strongly preferred
  • 8+ years of relevant medical writing experience in the biopharmaceutical industry
  • Proven ability to lead cross-functional teams through the authoring process
  • Experience in the preparation of New Drug Application/Marketing Authorization Application and IND/Clinical Trial Application submissions, protocols, CSRs, IBs, and other regulatory documents
  • Expert ability to interpret statistical and clinical data and to write and edit complex material with commitment to accuracy, clarity, consistency, and effectiveness
  • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
  • Strong knowledge of federal regulations, Good Clinical Practices, ICH E3 and other guidance, as well as applicable United States/International regulatory processes related to document preparation and production (including electronic CTD); 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
  • Excellent project management skills; able to manage multiple projects and adapt quickly to new situations and new project demands

Other Skills

  • Exceptional written communication skills; superior attention to details with commitment to accuracy
  • Ability to work independently with minimal supervision, multitask, and function effectively under pressure; adapt to change as needed
  • Broad knowledge of clinical development and statistics applications to the presentation of clinical data
  • 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
  • Strong PC experience and demonstrated proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint)

 

 

 

 

 

 

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