Senior Director, Medical Writing

Aveo Oncology • Boston, MA

19h • Onsite

About The Position

The Senior Director, Medical Writing is responsible for the development and execution of medical writing deliverables that support AVEO Oncology’s clinical development and regulatory writing portfolio. This individual is recognized as a scientific contributor and subject matter expert in the preparation of regulatory and clinical documentation and provides strategic medical writing leadership across assigned clinical programs. The incumbent is responsible for the efficient preparation of high-quality, scientifically accurate, and strategically aligned medical writing deliverables that support clinical development, clinical safety, and regulatory requirements. The Senior Director will partner cross-functionally to ensure key scientific and strategic communication points are effectively conveyed and are consistent across program documentation. The incumbent will provide strategic oversight as well as hands-on support for critical medical writing deliverables and will contribute to the development and maintenance of medical writing best practices, processes, templates, and SOPs.

Requirements

• Bachelor’s degree required; substantial coursework in life sciences or a related scientific discipline preferred
• A minimum of 10 years of medical writing experience within the biopharmaceutical industry or a contract research organization, with significant experience in clinical and regulatory medical writing
• Demonstrated experience leading medical writing activities for clinical development programs and complex regulatory deliverables
• Experience preparing clinical study protocols, clinical study reports, Investigator’s Brochures, regulatory briefing documents, clinical summaries and other regulatory submission documents
• Experience supporting global regulatory submissions and health authority interactions preferred
• Oncology regulatory and clinical writing experience strongly preferred; experience supporting late-stage or registrational oncology programs is highly desirable
• Experience with publication development, including abstracts, posters, presentations, and peer-reviewed manuscripts
• Strong understanding of clinical drug development, regulatory requirements, ICH guidelines, CTD structure, and industry standards for clinical and regulatory documentation
• Excellent ability to analyze and interpret clinical, scientific, and statistical data and communicate complex information clearly and accurately
• Excellent ability in searching and interpreting medical literature
• Demonstrated ability to provide strategic leadership while remaining hands-on with complex and high-priority medical writing deliverables
• Strong interpersonal and communication skills, both oral and written, with demonstrated ability to work effectively within cross-functional teams
• Demonstrated ability to influence stakeholders, drive consensus, and manage document development in a matrixed environment
• Strong project management and organizational skills with the ability to manage multiple priorities and timelines simultaneously
• Experience managing external medical writing vendors and consultants
• Strong attention to detail and commitment to scientific accuracy, consistency, and quality
• Technical aptitude and proficiency with systems and technologies used to support document development, collaboration, virtual meetings, and regulatory submissions

Nice To Haves

• Advanced scientific degree (PhD, PharmD, MD, MS or equivalent) preferred

Responsibilities

• Responsible for the planning, development, authoring, review, and finalization of clinical and regulatory documents, including clinical study protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), regulatory briefing documents, clinical summaries and overviews, responses to health authority questions, and other documents supporting global regulatory submissions
• Provides strategic medical writing leadership and develops document strategies in collaboration with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance/Safety, and other cross-functional stakeholders
• Is recognized as a scientific contributor and subject matter expert in the preparation of regulatory and clinical documentation
• Applies knowledge of regulatory medical writing, clinical development, and oncology to support clinical programs across multiple stages of development
• Represents Medical Writing on cross-functional clinical development and regulatory teams and provides strategic guidance regarding document content, messaging, timelines, and regulatory requirements
• Ensures scientific data, key messages, terminology, and communication points are accurate and consistent across program documentation
• Interprets and synthesizes complex clinical, scientific, and statistical information into clear, concise, scientifically rigorous documents
• Leads medical writing activities supporting IND/CTA submissions and other global regulatory submissions and contributes to NDA/BLA/MAA submission activities, as applicable
• Partners with Regulatory Affairs and Clinical Development to anticipate future documentation requirements and ensure medical writing activities are aligned with program and submission timelines
• Leads or contributes to publication planning and execution, including abstracts, posters, oral presentations, manuscripts, and other scientific communications
• Collaborates with internal and external authors to develop publication content that appropriately communicates the scientific significance and clinical relevance of study results
• Understands the oncology publication landscape, including relevant journals, congresses, audiences, and publication practices, and advises internal teams and authors accordingly
• Ensures alignment of publication content with scientific communication objectives, program strategy, and approved terminology
• Manages outsourced medical writing projects and external vendors to ensure quality, strategic alignment, timely completion, and adherence to allocated budgets
• Reviews and provides strategic and editorial guidance on documents prepared by internal and external medical writers
• Drives timelines and advances multiple complex projects simultaneously while proactively identifying and mitigating potential risks to quality, content, resources, and timelines
• Ensures medical writing deliverables comply with applicable regulatory requirements, ICH guidelines, company standards, and industry best practices
• Serves as an internal resource to cross-functional teams regarding regulatory medical writing and compliant scientific communication practices
• Contributes to the establishment and maintenance of medical writing Best Practices, SOPs, templates, and document development processes

Benefits

• AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior