Medical Writer
Hyderabad, Telangana, India · Tempo pieno
Sii il primo a candidarti
- Esperienza
- 2–5 anni
- Stipendio
- —
- Aperture
- 1
- Pubblicato
- 1 settimana fa
- Modalità di lavoro
- In ufficio
- Istruzione
- B.Pharma
- Requisiti di ammissibilità
- B.Pharma in any specialization may apply. The role is also described as suitable for candidates with PharmD, PhD, or a Master’s degree in life sciences, with a preference for PharmD or M.Pharm profiles.
- Riprendere
- È necessario candidarsi
Dove lavorerai
Descrizione del lavoro
About the Company
Indian Immunologicals Limited (IIL) is a wholly owned subsidiary of the National Dairy Development Board (NDDB), an autonomous body established in 1983 through an Act of Parliament. NDDB, headquartered in Anand near Baroda, Gujarat, is recognized as an institution of national importance and works to strengthen the cooperative movement in India, especially across dairying, fruits and vegetables processing, dairy machinery, and oilseeds processing.
Role Overview
IIL is seeking a scientifically minded Medical Writer with 2 to 5 years of experience in clinical research. The role is ideally suited to someone with exposure to vaccine clinical trials and a strong grasp of clinical and regulatory documentation. The selected candidate will create accurate, high-quality documents for sponsor projects while working in line with ICH-GCP and relevant regulatory standards.
Key Responsibilities
- Prepare and review clinical documents such as trial protocols, protocol amendments, clinical study reports, synopses, investigator brochures, informed consent forms, and related materials.
- Read clinical data carefully and convert it into clear, accurate summaries.
- Work closely with teams across Clinical Operations, Pharmacovigilance, Regulatory Affairs, and other functions.
- Maintain adherence to ICH-GCP principles and all applicable regulatory expectations.
- Handle several writing assignments at once while meeting deadlines and project schedules.
- Assist with regulatory filing activities and contribute to process enhancements.
Preferred Profile
- The ideal background includes a PharmD or M.Pharm degree.
- At least 2 to 3 years of medical writing experience in a pharmaceutical company or CRO is preferred.
- Prior involvement in vaccine clinical trials is highly desirable.
- Experience in drafting protocols and clinical study reports is important.
- A sound understanding of ICH-GCP is expected.
- Strong scientific writing and verbal communication abilities are needed.
- Experience supporting regulatory submissions will be an advantage.
- Working familiarity with CDSCO guidelines is preferred.
Eligibility
Candidates with a B.Pharma qualification in any specialization may apply. The description also indicates suitability for applicants with PharmD, PhD, or a Master’s degree in life sciences, with preference for PharmD or M.Pharm profiles.