Wipro Hiring Medical Writers | CER, PSUR, PMCF | Medical Devices
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities
- Eligibility / Qualifications
- Required Education
- Experience Requirement
- Key Skills
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- Who can apply for this Medical Writer position?
- Is immediate joining mandatory?
- What type of documents will I work on?
- Where is the job located?
- Is this a medical device-focused role?
- Summary Table
Wipro Medical Writer Jobs in Pune – CER, PMCF, PMS | B.Pharm / M.Pharm / Biomedical
Wipro hiring Medical Writer in Pune. 2–5 years experience in CER, PMCF, PMS, PSUR. B.Pharm, M.Pharm, Biomedical eligible.
Wipro is inviting applications for the role of Medical Writer (CER, PMCF, PMS) at its Pune location. This opportunity is aimed at experienced regulatory and medical writing professionals who have hands-on exposure to medical device documentation and post-market regulatory requirements. Candidates with strong expertise in Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF), Post-Market Surveillance (PMS), and PSUR drafting will find this role highly relevant and career-enhancing.
This position plays a critical role in supporting global medical device compliance and patient safety by ensuring accurate, regulatory-compliant documentation aligned with international standards. Immediate joiners are strongly preferred.
Company Overview
Wipro is a globally recognized technology and consulting organization with a strong presence in healthcare, life sciences, and medical device services. The company partners with leading pharmaceutical and medical device organizations worldwide, delivering high-quality regulatory, clinical, and compliance solutions.
Within its life sciences and healthcare vertical, Wipro supports regulatory submissions, medical writing, pharmacovigilance, clinical evaluation, and post-market compliance activities. Wipro’s regulatory and medical writing teams are known for their strong domain expertise, quality-driven approach, and adherence to global regulatory frameworks such as EU MDR and international safety reporting requirements.
Working at Wipro offers professionals long-term career stability, exposure to global clients, and opportunities to work on complex, high-impact regulatory projects.
Job Role & Responsibilities
The Medical Writer will be responsible for preparing, reviewing, and maintaining high-quality regulatory and clinical documentation related to medical devices and post-market activities.
Key Responsibilities
- Author and review Clinical Evaluation Reports (CER) in compliance with EU MDR and applicable regulatory guidelines.
- Prepare Post-Market Clinical Follow-up (PMCF) plans and reports.
- Develop and maintain Post-Market Surveillance (PMS) documentation.
- Draft and review Periodic Safety Update Reports (PSUR).
- Ensure consistency, accuracy, and regulatory compliance across all medical writing deliverables.
- Collaborate with cross-functional teams including regulatory affairs, clinical, quality, and project management.
- Perform gap assessments and updates to existing documents based on evolving regulatory requirements.
- Support internal and client audits by providing compliant and well-structured documentation.
- Ensure timely delivery of assigned documents while maintaining high quality standards.
This role directly contributes to regulatory compliance, patient safety, and successful medical device lifecycle management.
Eligibility / Qualifications
Required Education
Candidates must meet one of the following educational criteria:
Graduate in Biomedical Engineering, Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm), MSc Life Sciences, MSc Biotechnology, MSc Clinical Research or equivalent qualification.
Relevant Courses (comma-separated):
Biomedical Engineering, Pharmacy, Pharmaceutical Sciences, Life Sciences, Clinical Research, Regulatory Affairs, Medical Writing
Experience Requirement
- 2 to 5 years of relevant experience in medical writing or regulatory documentation.
- Mandatory hands-on experience in CER drafting, PMS, PMCF, and PSUR.
- Experience in medical device regulatory documentation is highly preferred.
Key Skills
- Strong knowledge of EU MDR and post-market regulatory requirements.
- Excellent medical writing, documentation, and analytical skills.
- High attention to detail and data accuracy.
- Ability to manage multiple deliverables under tight timelines.
- Strong written and verbal communication skills.
Location & Salary
Job Location: Pune, Maharashtra, India
Application Process
Interested and eligible candidates who can join immediately are requested to share their updated CV to the contact below.
Email: sarita.biswas@wipro.com
Candidates are advised to mention relevant experience in CER, PMCF, PMS, and PSUR clearly in their resume.
Frequently Asked Questions (FAQs)
Who can apply for this Medical Writer position?
Candidates with Biomedical Engineering, B.Pharm, M.Pharm, or Life Sciences backgrounds and 2–5 years of relevant medical writing experience can apply.
Is immediate joining mandatory?
Immediate joiners are strongly preferred for this role.
What type of documents will I work on?
You will work on CER, PMCF, PMS, and PSUR documents related to medical devices.
Where is the job located?
The position is based in Pune, Maharashtra.
Is this a medical device-focused role?
Yes. The role primarily supports medical device regulatory and post-market documentation.
Summary Table
| Company | Wipro |
|---|---|
| Vacancies | Medical Writer (CER, PMCF, PMS) |
| Required Education | Biomedical Engineering, B.Pharm, M.Pharm, MSc Life Sciences |
| Experience | 2–5 years in CER, PMCF, PMS, PSUR drafting |
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