Medical Writer (Part-Time) 2074331

Stratacuity: Proven Scientific Placement; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company in scientific placement is seeking an Account Executive specializing in medical writing for oncology clinical trials. The role involves developing regulatory documents, collaborating with teams, and mentoring junior writers. Candidates should have advanced degrees and extensive experience in oncology.

Qualifications

• 5+ years of medical writing experience, including 3+ years in oncology trials.
• Proven ability to author Phase I–III trial documents and regulatory submissions.

Responsibilities

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

Skills

Communication

Attention to Detail

Project Management

Education

PhD, PharmD, MD, MSc in Life Sciences

Tools

MS Office

Document Management Systems

Job description

Account Executive at Stratacuity: Proven Scientific Placement

Location: Remote

Job Overview: This role requires an expert Medical Writer skilled in crafting regulatory and scientific documents, with extensive experience in oncology clinical trials and oncology therapeutics, to support our clients' clinical development programs.

Primary Job Responsibilities:

• Develop and edit oncology trial documents such as study protocols, CSRs, and consent forms.
• Prepare content for regulatory submissions including INDs, NDAs, and BLAs.
• Collaborate with Clinical Development and Regulatory Affairs teams to ensure document accuracy.
• Translate complex data into clear, scientifically sound documents.
• Ensure 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 ability to author Phase I–III trial documents and regulatory submissions.
• Strong knowledge of oncology, clinical endpoints, ICH-GCP, FDA/EMA guidelines, and trial processes.
• Excellent communication skills, attention to detail, and project management abilities.
• Proficiency 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; membership in professional organizations (e.g., AMWA, EMWA) is a plus.

About Stratacuity: We prioritize ethics and building lasting relationships with exceptional biopharmaceutical talent. Your personal information is protected, and upon inquiry, a Stratacuity team member may contact you directly to discuss your career goals. We do not share your information without your prior consent.

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. We consider qualified applicants regardless of race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or other characteristics protected by law. We also consider applicants with criminal histories in accordance with applicable laws. If you need accommodations to use our website for searching or applying, please contact us.