Senior Medical Writer (Oncology)
Skills
Clinical ProtocolsContract Research OrganizationEnglishGood Clinical PracticeInformed ConsentMedical WritingOncology Clinical Research
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Bachelor’s degree required advanced degree preferred
- 5+ years experience in a CRO or pharmaceutical environment
- 3+ years relevant regulatory medical writing experience
- Oncology experience preferred
- Lead writer experience with at least 3 of protocols CSRs IBs DSURs or IND applications
- Experience collaborating directly with clients or sponsors
- Experience preparing document timelines and coordinating review cycles
- Proven experience with Fast Track Applications including INDs or BTDRs
- Familiarity with eCTD modules
- Knowledge of drug safety regulatory guidelines drug development biostatistics pharmacology clinical trial methodology and oncology
- Ability to work independently meet deadlines and manage multiple critical issues
- Strong oral and written communication skills
- Excellent interpersonal skills
- Advanced computer literacy in MS Office
Nice to have
- Collaborative
- Self-motivated
- Highly organized
- Detail-oriented
- Results-oriented
Day to day
- Prepare high-quality regulatory medical writing deliverables across the full study life cycle for oncology projects.
- Develop and update clinical and regulatory documents including protocols CSRs IBs DSURs INDs and informed consent forms.
- Work closely with clients medical monitors senior leadership and cross-functional teams to support timelines review cycles and strategic document development.
- Mentor new medical writers and contribute guidance feedback and support within a collaborative growing writing team.