Senior Medical Writer

Bean Hr Consulting; Gurugram District; Hybrid; INR 900,000 - 1,500,000; Full time

Job summary

Bean Hr Consulting is seeking a Senior Medical Writer in Gurugram to prepare, review, and maintain high-quality clinical and regulatory documents for medical devices. The role requires expertise in CER preparation, SSCP, systematic literature reviews, and regulatory submissions.

You will collaborate with Clinical, Regulatory Affairs, Quality, Research, and Engineering teams in a hybrid work setup. PMCF experience is advantageous and the ability to interpret complex data is essential.

Qualifications

• Experience in medical writing and clinical documentation.
• CER preparation and literature reviews.
• Knowledge of medical device regulations.
• Ability to interpret clinical data and assess benefit-risk.

Responsibilities

• Prepare and maintain CERs and SSCPs.
• Conduct systematic literature searches and reviews.
• Evaluate clinical data for benefit-risk.
• Ensure regulatory documentation compliance.
• Support regulatory submissions (510(k), PMA, IDE).
• Identify evidence gaps and support PMCF activities.
• Review clinical documentation prepared by junior writers.
• Collaborate with Clinical, Regulatory Affairs, Quality, Research, and Engineering teams.
• Support post-market activities as required.

Skills

Medical writing

Clinical documentation

Systematic literature reviews

Regulatory knowledge

Regulatory submissions

Education

Bachelor’s or higher in science

Job description

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.