Company Name: Symo Genesis India Pvt. Ltd.
Designation: Medical Writer
Location: Delhi / NCR( Connaught Place ) (WFH during Covid)
Experience: 2 – 5 years
Qualification: UG :MBBS in Any Specialization, BDS in Any Specialization, B.Sc in Any Specialization, B.Pharma in Any Specialization
PG :MDS in Any Specialization, Medical-MS/MD in Any Specialization, M.Pharma in Any Specialization, MS/M.Sc(Science) 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.
- Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
- Review statistical analysis plans and mock statistical output to determine the appropriateness of content/format for clinical writing.
- Attend internal technical team and client team meetings as required.
- May provide guidance to less experienced departmental members.
- Supervise collection of materials by the Medical Writing Assistant or Associate Medical Writer for assembly of client deliverables and for filing appropriately in project files.
- May participate in departmental or interdepartmental process improvement and training initiatives.
- May participate in development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
- Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the department.
- Excellent interpersonal, verbal and written communication skills.
- Client focused approach to work.
- A flexible attitude with respect to work assignments and new learning.
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Demonstrated understanding of the drug development process.
- Extensive clinical/scientific writing skills.
- Advanced word processing skills/familiarity with Word for Windows.
Bachelor’s degree/Master/PhD in Life Sciences/Health Related Sciences or equivalent.
Fluent in written and spoken English
Salary: Not Disclosed
Address: 1003, 10th Floor,, Tolstoy House, Tolstoy Marg, , NEW DELHI, Delhi, India
Website Link: https://www.symogen.com