Medical Writer Job at Apex Systems in Cambridge

Medical Writer – Oncology Clinical Trials

Base pay range: $90.00/hr - $150.00/hr.

Job #: 3013142

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.

What We’re Looking For

• 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.

Preferred

• CRO/biotech/pharma experience.
• Familiarity with eCTD submissions.
• AMWA/EMWA membership.

Benefits Overview

• Medical, dental, vision, life, disability, and other insurance plans.
• ESPP (employee stock purchase program) and 401K with company match.
• HSA on HDHP plan.
• SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions.
• Corporate discount savings program and other discounts.
• On-demand training program, certification prep, and access to technical and leadership courses/books/seminars.
• Dedicated customer service team and certified Career Coach.

Location

Greater Boston area.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Marketing, Public Relations, and Writing/Editing

Industries

IT Services and IT Consulting

Equal Opportunity Employer Statement

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.