Provide clinical and scientific support on clinical matters affecting preparation and submission of timely and sound information to the worldwide regulatory agencies. Work cross functionally to define the requirements and specifications for new products. Capable of developing communication plan, including publication plans for the therapeutic area. Review and approve documents needed to support products, such as product inserts, label updates, etc. Support in the development of rational strategic plans, including risk assessment plans, for future products and provide strategic leadership to the clinical R & D and medical affairs activities associated with technical support for products in the global market. Develop and maintain knowledge as to developments and trends in medical sciences, especially in the designated therapeutic area(s). Understand core scientific literature addressing clinical applications and safety of our products and be prepared to utilize this information in response to questions from internal and external customers, including Regulatory Authorities. Develop knowledge of regulatory, pharmacovigilance and quality assurance requirements in alignment with Global Business Practice Standards. Collaborate with Clinical Development and Operations in the development and writing of Clinical Trial Concept Sheets and Protocols as well as providing input to investigator’s brochure and interim/final Clinical Study Reports (CSRs).
Knowledge of GCP rules and regulations. Excellent leadership capabilities; teamwork oriented; interested in working in a multicultural and cross-functional environment. Well developed interpersonal skills; strong in providing education on scientific/clinical issues in a crisp and clear manner both to a peer and larger audience. Excellent verbal and written communication skills, public speaking and teaching skills. Strong Microsoft Office skills required Strong business acumen and impeccable integrity. Maturity, confidence and credibility to advice and influence senior management. M.B.B.S/Pharm D is required .