Senior Director, Medical Writing

Job description

JOB TITLE: Senior Director, Medical Writing

LOCATION: Boston, MA

DATE PREPARED: September 15, 2026

JOB SUMMARY

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.

PRINCIPAL DUTIES

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

BASIC QUALIFICATIONS

Bachelor's degree required; substantial coursework in life sciences or a related scientific discipline preferred

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

About AVEO

AVEO is a commercial‑stage, oncology‑focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno‑oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. 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.

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Worksite address

boston, MA, 02298, US

Who can apply

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