Are you a skilled Medical Writer looking for a remote opportunity in India? Parexel is hiring a Medical Writer I to join their team in Mohali or Hyderabad (Remote). If you have experience in aggregate safety reports, risk management plans (RMPs), and regulatory documents, this could be your next career move.
📍 Locations: India (Remote – Mohali/Hyderabad)
📌 Job ID: R0000032114
About Parexel
Parexel is a leading clinical research organization (CRO) dedicated to improving global health. From clinical trials to regulatory consulting, Parexel plays a crucial role in bringing new therapies to patients worldwide.
🔹 Mission: To advance healthcare through innovative clinical development solutions.
🔹 Culture: Collaborative, patient-focused, and driven by empathy.
🔹 Impact: Every role at Parexel contributes to life-changing medical breakthroughs.
Job Description: Medical Writer I
Key Responsibilities:
✔ Prepare, update, and manage Periodic Safety Reports (PSRs) including:
- PSURs, PBRERs, DSURs, PADERs, SASRs, RMPs, INDARs
- Clinical Overviews (CO), Safety Evaluation Reports (SER), Health Hazard Evaluations (HHE)
✔ Conduct literature reviews & epidemiology assessments for safety reports.
✔ Ensure regulatory compliance and high-quality documentation.
✔ Generate line listings, perform quality checks, and resolve discrepancies.
✔ Coordinate aggregate report submissions to health authorities.
✔ Schedule meetings, draft agendas/minutes, and track action items.
Required Skills:
- Strong knowledge of pharmacovigilance & regulatory writing.
- Experience in clinical study reports (CSRs), RMPs, and safety documents.
- Ability to critically appraise medical literature & epidemiological data.
- Proficiency in regulatory submission processes.
- Excellent scientific writing & attention to detail.
📌 Qualifications & Experience Required
Education:
✔ Bachelor’s/Master’s degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences, Medicine (MBBS/MD), or related fields.
✔ Advanced degrees (e.g., PhD, MPH, or MSc in Epidemiology/Pharmacovigilance) are a plus.
Experience:
✔ 2–4 years of experience in medical writing, pharmacovigilance, or regulatory affairs (preferably in a CRO/pharma company).
✔ Hands-on experience with:
- Aggregate reports (PSURs, PBRERs, DSURs, RMPs).
- Clinical Study Reports (CSRs) or safety narratives.
- Literature reviews & epidemiology data analysis.
✔ Familiarity with ICH-GCP, FDA/EMA guidelines, and regulatory submission processes.
Skills:
✔ Scientific writing with clarity & precision.
✔ Proficiency in Microsoft Office, PubMed, Embase, or other literature databases.
✔ Ability to interpret clinical trial data & safety signals.
✔ Strong project management & multitasking skills.
