Position : Medical Writer

These team members will be recruited at FHS PV unit for managing Medical Writing Activity. All these employees would be having expertise of Management of the team mailbox, overseeing the information flow from the social media platforms. Involved in preparation/review of regulatory documents SmPc and PIs, HHA. Involved in preparation and review of relevant guidelines and SOPs.

Experience : 3-5 years in medical writing and labelling activity in a pharmaceutical company.

Educational background: Bpharm/Mpharm/Phd

General Technical responsibilities
Accountable for Development, editing and approval of Standard Response letters (SRLs) to unsolicited medical enquireies from HCPs by obtaining information from internal sources (e.g safety, regulatory, development, research) and published materials
Adhere to requirements of the Risk Management Plan (RMP) and development training, educational material for HCPs and patients
Preparation and submission of Health Hazard Assessment Reports

Specific Technical responsibilities
Development, editing and approval of Standard response letters (SRLs) to unsolicited medical enquiries received from HCPs.
Development of training material for HCPs and patients as per the requirements of Risk Management Plan (RMP) like Patient Alert card, e-learning inputs, DHCP letter etc.
Develop, edit scientific inputs like Key paper summaries, Slide sets/ CME, Frequently Asked Questions (FAQ), Booklet, Medical Posters, Patient education leaflets , LBL.
Education content generation for website on marketed products/brands.
Medical and Scientific writing.
Preparation & review of custom response letters (CRLs) to medical enquiries received from US consumers, where information is not available with MICC vendor.
Preparation and submission of Health Hazard Assessment Reports.