Company Name:Symo Genesis India Pvt. Ltd.
Location:Delhi / NCR( Connaught Place ) (WFH during Covid)
Experience:2 – 5 years
Qualification:UG :BDS in Any Specialization, MBBS in Any Specialization, B.Sc in Any Specialization, B.Pharma in Any Specialization
PG :M.Pharma in Any Specialization, Medical-MS/MD in Any Specialization, MS/M.Sc(Science) in Any Specialization, MDS in Any Specialization
Job Description:Key Accountabilities:
- Under departmental supervision, the Medical Writer I will research, create, edit, and coordinate the production of Postmarkering and clinical documents, including PSUR, RMP ,PBRER, ACO, clinical study reports, protocols and Development safety update reports.
- Serve as the primary client contact, negotiating deliverable timelines, and resolving project related issues, under departmental supervision. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
- Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
- Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
- Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Symogen guidelines/SOPs including: distribute drafts, chair review meeting, incorporate revisions, document key project events, and complete sign-off procedures.
Address:1003, 10th Floor,, Tolstoy House, Tolstoy Marg, , NEW DELHI, Delhi, India