Director Medical Writer

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.

Roles and Responsibilities

• Lead the management and authoring of program-level and study-specific documents, including protocols, protocol amendments, investigator brochures, clinical study reports, and other documents needed to support regulatory interactions and filings.
• Lead internal and external subject matter expert reviews of documents and effectively manage the editing and revision process.
• Review medical writing deliverables to ensure consistency, accuracy, and clarity.
• Provide strategic guidance in developing the statistical outputs required for subsequent clinical regulatory documents and publications.
• Serve as the functional area representative on clinical study teams and advise teams on timelines, content, and format requirements for documents.
• Adhere to established regulatory standards including, but not limited to, ICH and FDA guidelines, company standard operating procedures (SOPs), work practices and approved templates.
• Assist with managing timelines and review cycles, developing content for, formatting, and submitting publications as needed, including manuscripts for peer-reviewed journals, and abstracts, oral presentations, and poster presentations for medical/scientific congresses and industry meetings in collaboration with internal clinical study teams and external researchers and/or scientists.
• Develop departmental infrastructure, processes, templates, and trackers, in collaboration with other functional areas. Assist in the development of SOPs and work practices.
• Monitor, track, and report program status to key stakeholders including management.
• Actively work to foster an environment of effective and collaborative working relationships among employees, management, and external partners.

Additional Skills & Qualifications

• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent with a minimum of 15 years related experience or an equivalent combination of education and experience. Advanced degree such as MPH or PhD preferred.
• Oncology experience required.
• Minimum 12 years working in industry.
• Must have led the medical writing team on at least two prior INDs or CTAs.
• Must have written at least two phase I oncology protocols and study reports.
• Must have written at least two investigator brochures.
• Strong analytical skills: ability to understand and interpret complex clinical and scientific data and formulate those data into content in a well-thought out and reviewer‑friendly manner.
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
• Proficient in English with extensive knowledge of English grammar.
• Experience and skill in document layout and formatting with keen attention to detail.
• High standard for quality, excellent attention to detail, and a methodical, diligent approach to proofreading, ensuring consistency in style, grammar, and punctuation.
• Mastery of referencing programs including Endnote or equivalent.
• Proficiency with MS Office and Adobe Acrobat.
• Certified by the American Medical Writers Association, or equivalent.
• Experience authoring various early to late-stage clinical development documents such as IND, CTA, protocol, investigator brochure, briefing documents, etc.
• Project planning and management experience, with excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
• Problem solving abilities at both strategic and operation levels to recognize potential scheduling and/or resource conflicts for projects and to provide recommendations.
• Solid understanding of scientific methods and scientific and medical terminology in oncology.