Medical Writer (Part-Time)

Apex Systems; Cambridge (MA); Remote; USD 70,000 - 90,000; Part time

Job summary

A leading company is seeking a part-time Medical Writer with expertise in oncology to develop regulatory and scientific documents. The role involves collaboration across clinical development teams and mentoring junior writers. Ideal candidates will have advanced degrees and extensive experience in oncology clinical trials.

Qualifications

• 5+ years of medical writing experience, including 3+ years in oncology trials.
• Expertise in NSCLC and breast cancer, especially small molecule kinase inhibitors.

Responsibilities

• Develop and edit key oncology trial documents, including study protocols and consent forms.
• Prepare regulatory submissions content for INDs, NDAs, and BLAs.

Skills

Communication

Attention to Detail

Project Management

Education

PhD in Life Sciences

PharmD

MD

MSc

Tools

MS Office

Document Management Systems

Job description

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Job#: 2074331

Job Description:

Medical Writer (Part-Time) 2074331

Location:

Remote

Job Overview:

In this role, you will be an expert Medical Writer responsible for crafting top-notch regulatory and scientific documents, utilizing your extensive background in oncology clinical trials and deep knowledge of oncology therapeutics to support our clients' clinical development programs.

Primary Job Responsibilities:

• Develop and edit key oncology trial documents, including study protocols, CSRs, and consent forms.
• Prepare regulatory submissions content for INDs, NDAs, and BLAs, pivotal for approvals.
• Collaborate with teams across Clinical Development and Regulatory Affairs for document accuracy.
• Translate complex data into clear, scientifically sound documents.
• Ensure document compliance with ICH guidelines and company SOPs.
• Mentor junior medical writers and stay updated on industry trends and guidelines.

Primary Job Requirements:

• Advanced degree (PhD, PharmD, MD, MSc) in life sciences or related field, with 5+ years of medical writing experience, including 3+ years in oncology trials.
• Expertise in NSCLC and breast cancer, especially small molecule kinase inhibitors.
• Proven skills in authoring Phase I–III trial documents and regulatory submissions.
• Strong knowledge of oncology, clinical endpoints, ICH-GCP, FDA/EMA guidelines, and trial processes.
• Exceptional communication, attention to detail, and ability to manage multiple projects efficiently.
• Proficient in document management systems, MS Office, templates, and style guides.
• Familiarity with eCTD submission processes and regulatory publishing.
• Experience in biotech, pharma, or CRO environments; professional organization membership (e.g., AMWA, EMWA) is a plus.