Job title: Senior Global Medical Expert
Company: Sanofi
Job description:
- Contribute to the generation of medical documents in collaboration with the MedHub and respective GMLs: product ID cards and diseases ID cards. * Liaise with expert GML as needed and during the ID cards preparation and review. * Review, ass
Contribute to the generation of medical documents in collaboration with the MedHub and respective GMLs: product ID cards and diseases ID cards. Liaise with expert GML as needed and during the ID cards preparation and review. Review, assess, and select the disease indications that will be presented in the Disease ID cards in alignment with GMLs. Review the ID cards content and propose amendments as per need. Perform periodic review to revise and update the ID cards (renewal opportunity, new guidelines publication) as per need, if there is an event on the product (company core data sheet (CCDS) change, label update ) Ensure high quality of ID cards in terms of formatting and scientific content. Draft the products’ medical sheets in accordance with the related ID cards. Contribute to /maintain a share point to ensure availability of pertinent documents/information for each maintained INN according to the agreed template for product due diligence. Support in compiling important information related to products in terms of ongoing regulatory processes, pharmacovigilance processes, and development processes (for Core Products) from all available sources and according to functions (Pharmacovigilance, Regulatory, Clinical). Participate in the regular portfolio reviews with product GMLs to gather the most up-to-date information on the products Liaise with the Global Safety Officer (GSO) as needed, to retrieve the study documents (protocol, CSR, presentations etc.) of INNs in the scope of divestment activity from Global repositories. Retrieve information on compassionate use and Risk Minimization Measures (RMM) information from PASS studies. Work with the New Business Model (NBM) team and be the touch point of the team for NBM topics and needed feedback. Build a network of team at the affiliate level and facilitate meetings for pruning activities essential for divestment. Support/work closely with GPR medical lead & divestment teams to identify potential alternative solutions and action plans for countries out of bundle scope where INN pruning is not feasible. Work with the local teams on the local essential/ lifesaving drug lists. As needed, may act as an SME/contribute to other GME activities such as medical assessment of PBRERs, ACOs, DSURs, benefit-risk assessments, expert statements for maximum defined dose (MDD), responses to Health Authority Queries, ad-hoc literature analyses, review/approve requests for managed access program or any other activities considered core activities of GMLs. Leadership and empowerment: leading by providing a strong medical position to the elaboration of the due diligence process Operational excellence: ensure operational excellence, compliance & scientific/ethics-based risk management, in full respect of all Sanofi internal processes, systems & activities Management skills: transverse management of internal partners. Strong team player, with capacity to build strong relationships and to collaborate successfully with external key stakeholders Agile, decisive and organized with an ability to prioritize. Highest personal integrity: committed to ethics and scientific standards. Must have a strong scientific background, board certified MD qualification preferably but considerably also other health care degrees. Medical operational excellence, time, and risk management skills Excellent written & verbal communication skills with comfort and experience in presentations. Excellent English language knowledge 7 years’ experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance, and in another medical/development function. Good understanding of Health Authorities (main guidelines of HTA bodies and Health Agencies) and Healthcare and Pharmaceutical environment (Regulatory, Market Access…) required Working knowledge of epidemiology, biostatistics, health economics/policy, ideal. Experience in successfully developing peer-reviewed publications. Experience working within an international company, with a transversal organizational environment and the ability to operate in a matrix, team-oriented structure. International and cross-cultural experience is highly valued. Experience working in project management mode, demonstrated track record in building and maintaining a network of internal experts, experience in working across and building effective partnerships. Experience in at least one of the Therapeutic areas – Cardiovascular, metabolism, Diabetes and Lipid, CNS, Oncology, immunology, hematology, radio-oncology, transplant, Anti-infectives, and Internal medicine. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Expected salary:
Location: Hyderabad, Telangana – Secunderabad, Telangana
Job date: Sun, 31 Jul 2022 22:55:19 GMT
Apply for the job now!