Senior Medical Writer II (Anand)

Company profile

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 Role The Senior Medical Writer II 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:
- With minimal supervision, 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, NDA, BLA, MAA, eCTD submission‑level documents).
- Supervises, trains, and mentors less experienced medical writers, as necessary.
- Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates.
- Strives to complete medical writing deliverables on time and within budget.
- With minimal supervision, manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project Apply on Kit Job: kitjob.in/job/4lxtx7