Medical Writer - Oncology Clinical Trials
Position Summary:
- We are seeking an experienced Medical Writer with a strong background in oncology clinical trials to join our growing company. The ideal candidate will have a deep understanding of oncology therapeutic areas and a proven track record of preparing high-quality regulatory and scientific documents in support of clinical development programs.
Key Responsibilities:
- Develop, write, and edit clinical and regulatory documents related to oncology clinical trials, including but not limited to:
- Clinical study protocols and amendments
- Investigator brochures
- Clinical study reports (CSRs)
- Informed consent forms
- Briefing documents
- Clinical sections of INDs, NDAs, BLAs, and other regulatory submissions
- Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and Safety teams to ensure content accuracy and consistency
- Interpret and synthesize complex clinical and scientific data into clear, concise, and scientifically sound documents
- Ensure all documents comply with ICH guidelines, regulatory requirements, and internal SOPs
- Participate in strategic planning and document timelines
- Mentor junior medical writers or contractors as needed
- Stay current with therapeutic area developments, industry trends, and regulatory guidance
Qualifications:
- Advanced degree (PhD, PharmD, MD, or MSc) in life sciences, medicine, or a related field
- Minimum 5 years of medical writing experience, with at least 3 years focused on oncology clinical trials
- In-depth understanding of oncology disease areas and clinical endpoints
- Extensive experience in authoring documents for Phase I–III oncology trials and regulatory submissions
- Strong knowledge of ICH-GCP, FDA/EMA guidelines, and clinical trial processes
- Excellent written and verbal communication skills
- High attention to detail, strong analytical skills, and ability to manage multiple projects under tight deadlines
- Proficiency with document management systems and MS Office Suite; experience with templates and style guides
Preferred Qualifications:
- Experience working in a CRO, biotech, or pharmaceutical company
- Familiarity with submission processes (eCTD) and regulatory publishing
- Membership in professional organizations such as AMWA or EMWA is preferred
Medical Writer - Oncology Clinical Trials
Position Summary:
- We are seeking an experienced Medical Writer with a strong background in oncology clinical trials to join our growing company. The ideal candidate will have a deep understanding of oncology therapeutic areas and a proven track record of preparing high-quality regulatory and scientific documents in support of clinical development programs.
Key Responsibilities:
- Develop, write, and edit clinical and regulatory documents related to oncology clinical trials, including but not limited to:
- Clinical study protocols and amendments
- Investigator brochures
- Clinical study reports (CSRs)
- Informed consent forms
- Briefing documents
- Clinical sections of INDs, NDAs, BLAs, and other regulatory submissions
- Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and Safety teams to ensure content accuracy and consistency
- Interpret and synthesize complex clinical and scientific data into clear, concise, and scientifically sound documents
- Ensure all documents comply with ICH guidelines, regulatory requirements, and internal SOPs
- Participate in strategic planning and document timelines
- Mentor junior medical writers or contractors as needed
- Stay current with therapeutic area developments, industry trends, and regulatory guidance
Qualifications:
- Advanced degree (PhD, PharmD, MD, or MSc) in life sciences, medicine, or a related field
- Minimum 5 years of medical writing experience, with at least 3 years focused on oncology clinical trials
- In-depth understanding of oncology disease areas and clinical endpoints
- Extensive experience in authoring documents for Phase I–III oncology trials and regulatory submissions
- Strong knowledge of ICH-GCP, FDA/EMA guidelines, and clinical trial processes
- Excellent written and verbal communication skills
- High attention to detail, strong analytical skills, and ability to manage multiple projects under tight deadlines
- Proficiency with document management systems and MS Office Suite; experience with templates and style guides
Preferred Qualifications:
- Experience working in a CRO, biotech, or pharmaceutical company
- Familiarity with submission processes (eCTD) and regulatory publishing
- Membership in professional organizations such as AMWA or EMWA is preferred