Medical Writer Job at Apex Systems in Cambridge

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.

Base Pay Range

$90.00/hr - $150.00/hr

Responsibilities

• 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.

Qualifications

• 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

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.

Equal Opportunity 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. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] (Do not submit resumes or solicit consultants to this email address).