Global Medical Writing Lead - Oncology & Submissions

Orion Corporation; Cambridge (MA); Hybrid; USD 150,000 - 200,000; Full time

Benefits offered by this job

Inclusive work environment

Opportunities for professional growth

Mission-driven organization

Job summary

A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development stages. The successful candidate will have over 7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge, Massachusetts. Responsibilities include leadership of writing activities, ensuring quality compliance, and process optimization within a collaborative environment. Competitive salary range of $150,000 to $200,000 is offered.

Qualifications

• 7–8+ years of medical writing experience in pharma, biotech, or CRO settings.
• Strong experience with clinical and regulatory document development.
• Experience with global regulatory submissions preparation (NDA/BLA/MAA).
• Experience in oncology, rare disease, or other complex therapeutic areas.

Responsibilities

• Oversee the creation and delivery of clinical documents across drug development.
• Serve as the primary medical writing lead for clinical programs.
• Ensure document strategy aligns with clinical, regulatory, and organizational objectives.
• Partner with various stakeholders for smooth documentation delivery.

Skills

Leadership capability

Exceptional communication

Scientific interpretation

Organizational skills

Documentation compliance

Education

Advanced degree in life sciences (PhD, PharmD, MD, or MSc)

Tools

Document management systems

Job description

A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development stages. The successful candidate will have over 7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge, Massachusetts. Responsibilities include leadership of writing activities, ensuring quality compliance, and process optimization within a collaborative environment. Competitive salary range of $150,000 to $200,000 is offered.