Regulatory_ Medical Writing – Trainee
Full Time
Gurgaon
Posted 1 day ago
Job Descriptions
- Support the drafting of basic medical and regulatory documents such as Prescribing Information (PI), biowaiver justifications, clinical and non-clinical overviews, Structured Product Labeling (SPL), bioequivalence (BE) templates, Technical Information Files (TIF), and supporting regulatory documents under senior guidance.
- Assist in reviewing source documents, clinical and non-clinical study reports, and published scientific literature to extract relevant information for regulatory submissions.
- Perform preliminary quality checks on regulatory and medical writing documents to ensure accuracy, formatting consistency, and alignment with regulatory guidelines.
- Support gap analysis activities for small molecules and biosimilars by identifying missing or unclear information in clinical and non-clinical datasets.
- Assist in preparing draft responses to regulatory or client queries, including updating documents based on feedback and review comments.
- Participate in literature searches and reference management to support medical and regulatory documentation.
- Learn and apply global regulatory guidelines and document standards relevant to medical writing.
- Support project tracking activities by maintaining documentation, version control, and work trackers.
- Communicate progress and challenges effectively with team members and supervisors.
- Demonstrate a proactive learning attitude, attention to detail, and willingness to adapt to evolving regulatory requirements.
Education
- Master’s degree in pharmacology (M.Pharm – Pharmacology) Only.
Knowledge, Skills and Abilities
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Excellent written and spoken English
- Result-oriented and deadline-driven approach
Other requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
Location
Gurgaon, Haryana (INDIA)