Apex Systems
Medical Writer - Oncology Clinical Trials
Our Greater Boston area client is seeking an experienced Medical Writer with expertise in oncology clinical trials to support their growing clinical development programs.
What You'll Do
- Author and edit oncology trial documents (protocols, CSRs, IBs, IND/CTA sections, NDAs/BLAs).
- Collaborate with clinical, regulatory, biostatistics, and safety teams.
- Translate complex data into clear, compliant documents.
- Ensure adherence to ICH-GCP, FDA/EMA guidelines, and SOPs.
- Mentor contractors/junior writers as needed.
- Advanced degree (PhD, PharmD, MD, MSc).
- 5+ years medical writing, 3+ in oncology.
- Must have previous experience with clinical trial expansion plans, global study protocols, protocol amendments, and interim analysis reports.
- Strong knowledge of oncology endpoints and regulatory submissions.
- Excellent communication, detail orientation, and ability to manage deadlines.
- Proficiency with MS Office, document systems, and style guides.
- CRO/biotech/pharma experience.
- Familiarity with eCTD submissions.
- AMWA/EMWA membership.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.