Lead Medical Writer – Interventional Oncology Devices (CEPs & CERs)
Experience:
7–10 Years
Role Overview:
We are seeking an experienced Lead Medical Writer with strong expertise in interventional oncology devices to support the development of high-quality regulatory documents, specifically Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs). The ideal candidate will bring deep therapeutic area knowledge and demonstrated success in medical writing for medical devices, particularly within oncology and interventional procedures.
Key Responsibilities:
- Lead the preparation, review, and maintenance of:
oClinical Evaluation Plans (CEPs)
oClinical Evaluation Reports (CERs)
oOther clinical and regulatory documents
- Provide subject-matter expertise in interventional oncology devices
- Conduct literature searches, appraisal, and data analysis to support clinical evaluations
- Ensure compliance with relevant global regulatory guidelines
- Collaborate with cross-functional teams
- Drive document strategy, timelines, and content quality as a lead-level contributor
- Mentor junior writers and provide scientific/technical guidance where required
- Interface with clients/stakeholders to understand requirements and deliver tailored outputs
Required Qualifications:
- Advanced degree (PhD/MD/Masters) in Life Sciences, Biomedical Engineering, Pharmacy, or related field
- 7–10 years of experience in medical writing for medical devices
- Proven experience in authoring CEPs and CERs
- Strong domain expertise in interventional oncology devices
- Excellent scientific writing, critical appraisal, and communication skills
- Experience in leading projects and interacting with global clients
Preferred Skills:
- Familiarity with oncology clinical practices and minimally invasive therapies
- Knowledge of risk management, benefit-risk analysis, and state-of-the-art evaluation
- Project management and stakeholder handling experience
Key Competencies:
- Strategic thinking and leadership
- Strong attention to detail and regulatory compliance
- Ability to manage multiple deliverables under tight deadlines
- Effective collaboration and client engagement skills
Why Join Us:
- Opportunity to work on cutting-edge interventional oncology technologies
- High-visibility role impacting regulatory success and client outcomes
- Collaborative and innovation-driven environment
