Inventive Health Clinical
inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.
Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients’ therapies to market.
Title:Senior Medical Writer | Gurgaon
- Work with cross-functional departments e.g. R&D, LOC, medical, regulatory and commercial departments
- Takes responsibility for preparation of medical information responses to a high standard, working in accordance with guidelines and SOPs
- Participates in both internal and external project team meetings and liaises directly with the customer on medical and/or technical writing issues, as appropriate and with senior support as needed.
- Review responses or other project deliverables prepared by other Medical Writers and provide appropriate feedback. Gives guidance to less experienced Medical Writers and assists in their training and development.
- May act as Project Manager for a small stand-alone projects
- Keeps abreast of current data, trends in medical information and/or medical affairs, developments and advances in area of drug development/medical and/or technical writing.
- May propose revisions to SOPs or suggest process improvements for consideration. Complies with Company SOPs and participates in the implementation of new SOPs
- Understanding the intent of enquiry
- Providing evidence based responses to medical enquiries (especially efficacy/safety related queries) in collaboration consultation with category medical, wherever applicable. This involves literature search skills and therapeutic area knowledge
- Updating existing responses as per label change as and when required
- Working on different databases simultaneously
- Maintaining the tracker and updating it on daily basis
- Preparation of “Global Guidance Documents” in response to frequent queries
BDS or MDS Degree with at least 4-6 years of broad-ranging relevant experience in Medical Writing /Pharmacovigilance
Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally
Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results
Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and authority
Ability to assess and prioritize workload
Careful attention to detail and accuracy
Knowledge/experience with OTC products will be useful
to apply to Inventive Health care.