Fully Remote - Associate Director, Medical Writing (Biopharmaceutical)

Remote Flexibility

Our client is currently seeking a highly motivated Associate Director, Medical Writing, to be responsible for the planning, coordination, and oversight of all medical writing activities within the company. In this role, you will lead the Medical Writing function and be responsible for developing and implementing a standardized process for the development of clinical and regulatory documents and managing external resources. Success in this role requires you to be adept at working cross-functionally with stakeholders.

This position is based in our South San Francisco, CA, location, with flexibility to work remote some of the time, and will be required to be on-site for meetings on a routine basis.

Specific responsibilities include, but are not limited to:

• Planning, managing, and aligning medical writing activities and communication across multiple projects and development programs
• Overseeing the development of critical documents, including Investigator Brochures, protocols/protocol amendments, and clinical study reports, in compliance with SOPs, ICH E3 guidelines, other applicable regulatory guidance documents, and local requirements
• Supporting the selection of CROs and vendors and providing project-level oversight of CROs and other vendors
• Developing the medical writing functional area, including creation of standardized policies, procedures, work instructions, timelines, document tools and templates, style guide, and best practices
• Engaging and communicating with functional area leads and stakeholders across development programs to support medical writing activities
• Providing leadership in planning and contributing to key regulatory submissions to US and global health authorities (NDAs, MAAs, INDs, annual reports, DSURs).
• Ensuring key messages are clear and consistent within and across documents
• Contributing strategically and scientifically at the project and/or study team level
• Forecasting costs for individual medical writing projects
• Generating and tracking medical writing project budgets against planned budget and timelines
• Partnering with legal and financial functions to negotiate medical writing contracts and budgets
• Identifying and anticipating issues related to budget and project milestones and lead mitigation and resolution efforts for issues identified
• Creating and regularly updating medical writing project timelines and ensure that medical writing timelines are in sync with the program timelines
• Acting as a key contributor to the organization cross-functionally to promote organizational goals and knowledge sharing
• Leading and driving process improvement initiatives for medical writing
• Setting up and leading kick off meetings and comment resolution meetings
  
  

Qualifications include:

• Bachelor’s degree with 8 years of pharmaceutical/biotechnology medical writing experience including development of regulatory documents for Phase I-III clinical trials. A Master’s or PhD degree may be considered in place of years of relevant experience
• Subject matter expert in the regulatory medical writing process with strong attention to detail
• Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data
• Expert knowledge of AMA style, medical terminology, and clinical data analysis
• Demonstrated experience in the preparation of protocols, study reports, investigator brochures, safety updates, and other clinical and regulatory documents required for IND and MAA submissions
• Demonstrated experience in a lead medical writing role managing projects of varying size and complexity, preferably within a pharmaceutical company or contract research organization (CRO)
• Experience managing medical writing vendors and/or contract medical writers
• Excellent communication skills to ensure that medical writing plans and processes are transparent, strict timelines are met, and risks, issues, and results are clear to all stakeholders
• Outstanding organizational skills with the ability to multi-task, prioritize, negotiate, manage competing priorities, analyze and solve problems
• Thorough knowledge of regulatory and compliance requirements for medical writing, including ICH E3 and other applicable guidelines
• Willing to embrace change and work in a changing environment
• Able to work collaboratively across cultures and geographies
• Proficient in Microsoft® Word, Project, PowerPoint, Excel
• Proficient in Adobe Acrobat, and electronic document templates (e.g. eCTD templates)
  
  

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