4C Pharma Hiring Senior Medical Writer in Hyderabad
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Educational Requirements
- Experience Requirements
- Key Skills & Competencies
- Location & Salary
- Application Process
- FAQs
- Who can apply for this role?
- Is PSUR and PMS experience mandatory?
- Is this role open to freshers?
- What is the notice period preference?
- Is this a remote position?
Senior Medical Writer Vacancy Hyderabad | Medical Devices
4C Pharma hiring Senior Medical Writer in Hyderabad. 2–4 years experience, medical devices, PSUR & PMS expertise.
A leading medical devices consulting organization, 4C Pharma, is hiring a Senior Medical Writer – Medical Devices for its Hyderabad office. This role is designed for experienced professionals with strong expertise in post-market surveillance (PMS), periodic safety update reports (PSUR), and EU MDR-compliant clinical and safety documentation. If you have hands-on experience in medical device regulatory writing and want to work closely with cross-functional and regulatory teams, this opportunity offers high professional and career value.
Company Overview
4C Pharma is a specialized regulatory and clinical consulting organization supporting global pharmaceutical, biotechnology, and medical device companies. The company is known for its deep expertise in regulatory affairs, clinical evaluation, pharmacovigilance, and medical writing across international markets.
Within the medical devices domain, 4C Pharma supports clients through the entire product lifecycle, from clinical evaluation and conformity assessment to post-market surveillance and regulatory compliance under EU MDR and global regulations. The organization maintains strong quality systems, regulatory intelligence capabilities, and client-facing expertise, making it a trusted partner for complex regulatory programs.
Job Role & Responsibilities
The Senior Medical Writer will be responsible for authoring, reviewing, and managing high-impact regulatory and safety documents for medical devices in compliance with EU MDR and global requirements.
Key responsibilities include:
- Authoring and reviewing Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), PMCF plans and reports, SSCPs, PSURs, and other medical device safety documentation
- Reviewing and analyzing safety data from clinical investigations, post-market surveillance activities, complaints, and adverse event reports
- Conducting literature searches, data evaluations, trend analyses, and hazard assessments to define device-specific benefit–risk profiles
- Preparing clear, compliant summaries aligned with MEDDEV, MDCG, and EU MDR expectations
- Collaborating with Regulatory Affairs, Clinical, Quality Assurance, and Medical Affairs teams on regulatory deliverables
- Supporting client interactions, regulatory submissions, audits, and inspections
- Preparing responses to regulatory authority queries and notified body feedback
- Ensuring compliance with EU MDR requirements, including MEDDEV 2.7, MEDDEV 2.12 series, ISO 14155, and internal quality standards
- Developing training materials and contributing to process improvement and standardization initiatives
- Staying current with evolving regulatory frameworks such as MDCG guidance and IMDRF standards
- Mentoring junior medical writers and supporting team-wide knowledge sharing
This role plays a direct role in ensuring medical device safety, regulatory approval, and continued market access.
Eligibility / Qualifications
Educational Requirements
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or related disciplines
- B.Tech or M.Tech in Biomedical Engineering, Electronics, or Mechanical Engineering will also be considered
Experience Requirements
- 2 to 4 years of experience in medical writing or regulatory documentation for medical devices
- Mandatory hands-on experience with PSURs and PMS documentation
- Practical exposure to CERs, CEPs, PMCF documentation, SSCPs, and MAUDE database preferred
Key Skills & Competencies
- Strong understanding of medical device safety reporting and post-market surveillance
- In-depth knowledge of EU MDR and associated guidance documents
- Excellent analytical, scientific writing, and communication skills
- High attention to detail and document accuracy
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
- Ability to manage multiple projects and regulatory timelines
Location & Salary
- Job Location: Hyderabad
- Work Mode: Work from Office
- Experience Level: Senior (2–4 years)
- Salary: Not disclosed; compensation will be competitive and aligned with industry standards
Application Process
Interested candidates who meet the eligibility criteria should apply by sharing their updated resume via email.
Apply via Email: sushmitha.r@4cpharma.com
Candidates are advised to mention “Senior Medical Writer – Medical Devices” in the subject line of the email.
FAQs
Who can apply for this role?
Professionals with 2–4 years of medical device medical writing or regulatory documentation experience can apply.
Is PSUR and PMS experience mandatory?
Yes. Hands-on experience with PSUR and PMS documentation is mandatory for this role.
Is this role open to freshers?
No. This is a senior-level role requiring prior industry experience.
What is the notice period preference?
Immediate joiners or candidates with up to 30 days’ notice period are preferred.
Is this a remote position?
No. This is a work-from-office role based in Hyderabad.
| Company | 4C Pharma |
|---|---|
| Vacancies | Senior Medical Writer |
| Required Education | Pharmacy, Life Sciences, Nursing, Engineering |
| Experience | 2–4 years |
To apply for this job email your details to sushmitha.r@4cpharma.com
