Director, Medical Writing

Want to use specialized AI just for BioPharma to compete for this highly desirable role? Check out our updated tool https://jobsai.medicinetomarket.com today!

Role Summary

The Director, Medical Writing (MW) is responsible for managing MW and quality review (QR) activities in conjunction with the Head of MW in a timely, accurate, and efficient manner, in compliance with company and global regulations, including ICH and GCP. With minimal oversight and self-guided decision-making, the MW Director will work cross-functionally with internal departments and external resources to oversee high-quality, on-time deliverables in support of clinical, non-clinical, and regulatory needs. In addition, the Director supports and mentors less experienced MWs, while providing administrative and project management support to the Head of MW, including setting up and amending vendor contracts, organizing group training, communicating pivots or shifts in company objectives, presenting work and status cross-functionally, resolving conflicts and risks. The MW Director may have individual contributor responsibilities at the document level and may or may not have direct report responsibilities. This role can be based in Brisbane or Hayward, CA, or remote.

Responsibilities

• Ensure appropriate communication on project and program-related matters with the Head of MW.
• Oversee cross-functional communication and deliverables for multiple project and program-related deliverables and initiatives, including creation and maintenance of timelines, as needed.
• Independently prepare and finalization / oversee finalization of Clinical and Regulatory documents with minimal input, including document drafting, coordination and adjudication of comments, initiating and finalizing QR, interacting with Regulatory Submissions.
• Deliver projects on-time and to the highest standards of quality.
• Participate in MW and cross-functional process improvement initiatives on document standards, template development, and document or MW processes. May be involved in SOP review and development.
• Participate in cross-functional team strategy discussions, which may include nonclinical, clinical, and regulatory strategies.
• Work with clinical and regulatory teams to ensure high-quality, on-time delivery of documents in accordance with regulations, standards, and guidelines.
• Lead document review and comment resolution meetings with cross-functional teams.
• Partner with the regulatory team to prepare other documents, as needed, for submission to Health Authorities.
• Oversee document preparation activities and tracks progress against targets; produce timely and accurate status update reports.
• Build and maintain a positive working relationship with key stakeholders, team members and vendors.
• Drive and communicate medical writing activities, plans, scope(s) of work and ways of working across the organization.
• Direct, train, and assist other medical writers in the writing and editing of clinical and regulatory documents.
• Work with third parties including academic partners, key opinion leaders, and contractors as needed.
• Execute literature reviews and competitive landscape research contributing to development strategy.
• Oversee vendor contracts, amendments, outlines scope of work; oversee outsourced projects and/or programs.
• May have direct reports.

Qualifications

• Master’s degree in life sciences; PhD preferred.
• 10+ years of Regulatory Writing experience in a pharmaceutical, biotech, or CRO environment; experience in oncology or rare diseases is desired.
• Excellent verbal communication and technical writing skills including tact and diplomacy in dealing with complex projects and teams.
• Shows strong leadership and autonomy and has ability to negotiate and collaborate within a cross-functional team environment.
• Demonstrated success in the preparation of clinical and regulatory documents, as well as overseeing timelines and deliverables for direct reports or contracted writers.
• In-depth knowledge of industry regulations, guidance, and regulatory documentation requirements including thorough knowledge of ICH guidelines.
• Experience interacting and communicating timeline expectations with cross functional study team members.
• Expert/highly proficient in the functionality of MS Word, Excel, Adobe Acrobat, and PowerPoint.
• Experience with electronic document management systems (e.g., Veeva Vault).
• Familiarity with statistical analysis concepts and techniques preferred.

Skills

• MS Word, Excel, Adobe Acrobat, PowerPoint proficiency
• Electronic document management systems (e.g., Veeva Vault)
• Familiarity with statistical analysis concepts and techniques