Manager - Medical Affairs

Manager - Medical Affairs

Piramal Healthcare

Maharashtra

16 hours agoFull–time

Job Title: Manager, Medical Affairs Business Unit: PCC Band/Grade: Band 2A Location: Kurla Last updated on: Jan 2020 Department; Group: Regulatory/ Medical Affairs Degree of Travel required: Low Purpose of Job The Manager, Medical Affairs is responsible for the portfolio of Piramal Critical Care products globally. He/She will be responsible for performing medical reviews and delivering medical and scientific insights to internal and external customers. The incumbent will work closely with the Pharmacovigilance and Medical Information teams to ensure accurate and timely responses to questions received by customers. He/She will also represent Medical Affairs as part of the Promotional Review Committee to ensure our Brand promotional materials are accurate and adhere to all regulations. May also support business development initiatives and provide medical insights for products under consideration. Key stakeholders External Internal Country Distributors, Health Authority (HA), external partners Cross-Functional: Sales, Marketing, Regulatory Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Program Management, Business Development, Senior Management Reporting structure Role directly reports to Positions that report into this role Vice President, Regulatory Affairs Not Applicable Essential Qualifications B Pharm or MS degree in scientific discipline or equivalent education and a minimum of 5 years' experience in a Medical Affairs role. Strong knowledge of medical strategy and health authority requirements. Essential Experience Must effectively multi-task, establish priorities and work in a fast paced environment. Must demonstrate leadership skills and the ability to interact with management. Possess excellent written and verbal communication abilities. Must possess strategic influencing skills, the ability to manage a diverse group of responsibilities and work effectively in a cross-functional team environment. Job Conditions This position is based in the Kurla Corporate office. Values Knowledge • Expertise - we strive for a deeper understanding of our domain • Innovation - we aspire to do things creatively Action • Entrepreneurship - we are empowered to act decisively and create value • Integrity - we are consistent in our thoughts, speech and action Care • Trusteeship - we protect the interests of our customers, community, employees, partners and shareholders • Humility - we aspire to be the best, yet strive to be humble Key Roles/Responsibilities: • To manage all Medical Affairs activities and obligations across all commercial and pipeline products, in all geographies, for Piramal Critical Care • Responsible for monitoring the conduct and progress of the clinical investigations (Contact on US Form 1571) • Contact person for CT.gov studies • Address all Medical Affairs queries for PCC products and relationships (e.g., CMOs, distributors, etc.) • Responsibility for pending and future development/clinical projects and support the implementation of regulatory strategy • Coordinate with our pharmacovigilance and medical information teams on a global basis to ensure