Senior Medical Writer

Hiring: Senior Medical Writer

Experience: 710 Years

Location: Gurugram

Work Mode: Hybrid
Industry: Medical Devices / Healthcare / Clinical Research

Job Summary:

We are looking for an experienced Senior Medical Writer to prepare, review, and maintain high-quality clinical and regulatory documentation. The ideal candidate should have strong expertise in medical writing, clinical evaluation, scientific literature reviews, and regulatory documentation, preferably within the medical device industry.

Key Responsibilities:

• Prepare and maintain Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCP), and other clinical/regulatory documents.
• Conduct systematic literature searches and reviews to identify and summarize relevant clinical evidence.
• Evaluate clinical data and support benefit-risk assessments for medical devices.
• Ensure documentation complies with applicable regulatory requirements, standards, and guidelines.
• Support regulatory submissions, including 510(k), PMA, and pre-IDE documentation, as applicable.
• Identify clinical evidence gaps and support Post-Market Clinical Follow-Up (PMCF) activities.
• Review clinical documentation prepared by junior writers and external contributors.
• Collaborate with Clinical, Regulatory Affairs, Quality, Research, and Engineering teams.
• Support clinical risk analysis, complaint reviews, and post-market activities as required.

Required Skills:

• Strong experience in medical/scientific writing and clinical documentation.
• Hands-on experience with CER preparation and systematic literature reviews.
• Knowledge of medical device regulations and clinical evaluation requirements.
• Understanding of clinical data interpretation and benefit-risk assessment.
• Excellent technical writing, analytical, and documentation skills.
• Ability to interpret regulatory guidelines, scientific publications, and complex technical documents.

Preferred Qualifications:

• Bachelor's or higher degree in a scientific, medical, nursing, or related healthcare discipline.
• Medical device industry experience.
• Experience in Clinical Affairs, Clinical Evaluation, Quality, or Regulatory Affairs.
• Experience mentoring junior team members and reviewing clinical documentation.

Interested candidates can share their updated resume to [email removed]