To author and review regulatory & other medical writing deliverables independently as per high-quality standards (internal & external) and within expected timelines. Support in building technical & functional expertise within the group by designing & executing robust training programs. Contribute/support other writers for manuscripts, slide sets, abstracts, posters, other techno-commercial documents as needed.
- Authoring & reviewer of CSRs, Protocol, IB, Briefing books & other regulatory submission documents (including CTD modules) for US FDA, EMEA and rest of the world. Additionally, contribute to manuscripts, abstracts, posters, other techno-commercial documents as needed.
- Work with data analysts and statisticians on Real world and other evidence generation projects.
- Author deliverables with scientific accuracy, based on facts from available sources and meeting quality standards (including grammar and editorial requirements).
- Follow all internal and client processes and adhere to various ICH / regulatory guidelines and other industry best practices.




- Undertake quality control (QC, scientific reviews and/or proofreading of the above-mentioned deliverables.
- Showcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains.
- Conduct client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner.
- Act as project lead/delivery lead for assigned client and responsible for healthy partnership for each account.
- Support innovation initiatives, including but not limited to automation and process improvement.
- Conduct robust training programs for the team & support thought leadership activities in the domain.
- Responsible for audit readiness of the department overall. Guide development of the SOPs, work-instructions and other documentation.
- Support proactively in business expansion & department operation activities as nee

📌 Principal Medical Writer (India)
🏢 Catalyst Clinical Research
📍 India