Parexel Hiring – Medical Writer I / II | India Remote Jobs
Parexel, a leading global Contract Research Organization (CRO), is hiring for the role of Medical Writer I / II. This opportunity is open to freshers and experienced professionals, with preference for candidates having exposure to Pharmacovigilance (PV) or Regulatory Affairs.
The role is suitable for candidates holding degrees such as B.Pharm, M.Pharm, MSc, MBBS, BDS, Nursing, or Physiotherapy, who are interested in building or advancing a career in medical writing and clinical documentation. Medical Writers at Parexel support the development of clinical, regulatory, and safety‑related documents, working closely with cross‑functional global teams in a regulated environment.
This position offers strong exposure to global clinical research programs, structured training, and long‑term career growth within medical writing, regulatory science, and pharmacovigilance documentation.
Table of Contents
Job Overview
- Position: Medical Writer I / II
- Department: medical writing
- Location: Remote,India
- Experience: Fresher to experienced
- Qualification: B.Pharm, M.Pharm, MSc, MBBS, BDS, Nursing, Physiotherapy
- Job Type: Full-Time
- Last Date to apply: 10 April 2026
Key Responsibilities – Medical Writer I / II at Paraxel
- Prepare, update, and maintain aggregate safety reports including RMP, CC‑RMP, PSUR, PBRER, DSUR, PADER, ACOs, and INDARs.
- Draft Clinical Overviews, Safety Evaluation Reports, Drug Safety Reports, and other regulatory documents.
- Prepare health authority response documents and perform labeling comparisons.
- Ensure all deliverables comply with global pharmacovigilance regulations, guidelines, and SOPs.
- Conduct systematic literature reviews and critical appraisal of scientific publications.
- Develop literature search strategies to support epidemiology sections of safety reports.
- Analyze incidence, prevalence, and risk factors relevant to safety assessments.
- Apply epidemiological calculations to support safety signal validation and interpretation.
- Prepare patient narratives using clinical and safety databases for CSR support.
- Collaborate closely with Study Management Teams (SMTs) to ensure data accuracy and alignment.
- Perform quality checks, formatting, and final compilation of clinical narratives and related documents.
- Perform signal detection and evaluation using both qualitative and quantitative approaches.
- Manage the end‑to‑end signal lifecycle, including tracking, assessment, documentation, and reporting.
- Present safety signal findings in cross‑functional safety review meetings.
- Ensure data consistency, integrity, and regulatory compliance across all medical writing deliverables.
- Conduct QC checks for aggregate safety reports and other documents.
- Act as a client‑facing medical writer for senior‑level roles, supporting client communication as required.
- Participate in audits, inspections, and process improvement initiatives, ensuring inspection‑ready documentation.
Required Skills & Qualifications
- Prior experience in Regulatory Affairs, Pharmacovigilance, or a related field is desirable.
- Good understanding of medical terminology and clinical concepts relevant to medical writing and safety documentation.
- University degree in Life Sciences, Health Sciences, or Biomedical Sciences, including but not limited to:
- Pharmacy
- Microbiology
- Biochemistry
- Biotechnology
- Biophysics
- Degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing, particularly those involving patient exposure in hospital‑based environments, is an added advantage.
Why Join Paraxel?
- Join Parexel, a globally recognized Contract Research Organization (CRO) that supports leading pharmaceutical and biotech companies across clinical research, regulatory, and pharmacovigilance domains.
- Gain hands‑on experience across aggregate safety reports, regulatory writing, literature reviews, signal detection, and clinical narrative writing, working on global programs.
- Parexel provides structured onboarding and learning for freshers, along with advanced responsibilities and client interaction opportunities for experienced medical writers.
- Benefit from continuous learning through role‑specific training, therapeutic area exposure, mentoring, and clear career progression paths within medical writing and PV/regulatory functions
How to Apply
Interested candidates should apply only through the official company career website using the link provided below.
Important Disclaimer
This job post is shared for informational purposes only, based on publicly available job details. Candidates are advised to verify eligibility, job responsibilities, and application procedures from the official website before applying.
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FAQ-Medical Writer I / II at Paraxel
1. Who can apply for the Medical Writer I / II role at Parexel?
Candidates with degrees such as B.Pharm, M.Pharm, MSc, MBBS, BDS, Nursing, or Physiotherapy can apply. Both freshers and experienced professionals are eligible.
2. Is this role suitable for freshers?
Yes. Fresh graduates with strong scientific writing skills and basic knowledge of pharmacovigilance or regulatory processes can apply for Medical Writer I roles.
3. What experience is preferred for this position?
Experience in Pharmacovigilance, Regulatory Affairs, or Medical Writing is preferred but not mandatory for entry‑level roles. Experienced candidates may be considered for Medical Writer II positions.
4. What type of documents will I work on?
Aggregate Safety Reports (PSUR, PBRER, DSUR, RMP, etc.)
Clinical Overviews and Safety Evaluation Reports
Patient narratives and CSR‑related documents
Health authority responses and labeling documents
5. Does the role involve literature review and epidemiology work?
Yes. The role includes systematic literature reviews, epidemiological analysis, and development of search strategies to support safety and regulatory documents.
