For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce current therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D; technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Principal Medical Writer position is responsible for authoring medical writing deliverables with a focus on quality, accuracy, and efficiency, and provides medical writing support to ProPharma clients.

Essential Functions:
- Ensures appropriate communication on project- and program-related matters with medical writing leadership, internal functional area heads,



and internal resources/consultants as applicable.
- Manages clinical program documents for assigned clients, such as protocols, protocol amendments, IBs, ICFs, patient narratives, study reports, as well as more complex regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submissionlevel documents) as assigned.
- Leads cross-functional coordination of resources (e.g., internal resources/consultants) to manage medical writing and QC deliverables as assigned.
- Independently authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, N

📌 Principal Regulatory Medical Writer (Hyderabad)
🏢 Propharma Group
📍 Hyderabad