About the company : Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives. https://www.linkedin.com/company/bioconbiologics/about/ KEY RESPONSIBILITIES : The incumbent will work closely with the Clinical Development and Medical Sciences (CDMA) and National and International Regulatory Affairs teams under the supervision of the Digital Business Partner, leading key technology and digital projects and ensuring successful rollouts More specifically s/he will lead the following responsibilities : - Serves as key driver of multiple projects within Clinical, Medical & Regulatory, working closely with Business stakeholders, End user and Vendor partners - Ensures all project stakeholders are aligned on the agreed scope and goals of the project - Responsible for oversight of creation, review and approval of all appropriate project and validation deliverables in line with the project RACI matrix - Directly responsible for timely and successful completion of projects, holds project team and vendor partner accountable for defined tasks and deliverables - Creates and manages project schedule, project resource allocation and project milestones, allocating sufficient time to ensure quality product and deliverables - Tracks and reports on the status of project activities and deliverables including validation documentation - Manages project risks and issues, identify mitigations and workarounds and seek management attention proactively when required - Approves project milestone based payment to vendor partner upon successful completion of predefined milestones, coordinates with Business Partner/Product Owner and Finance team for invoice processing, etc. YEAR ONE CRITICAL SUCCESS FACTORS : - Successfully complete project implementations within time, cost and quality standards, in line with business expectations - Successfully complete implementation of IT M&A Integration program for Clinical, Medical and Regulatory functions - Successfully complete planned data transfers into potential source systems PROFESSIONAL EXPERIENCE / QUALIFICATIONS : - Bachelors in Engineering or Masters degree in a related discipline, including a minimum of 7-12 years of experience gained in technology implementation in the Pharma space - Specific experience in handling medium to large scale technology projects, preferably in a multi-site environment - Experience working for Global Pharma companies and environment - Excellent oral/ written communication skills - Self-starter, with the ability to work and execute independently with minimal oversight Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act

Bangalore

Biocon - Project Manager - Clinical/Medical & Regulatory Function 

Job Description for Biocon - Project Manager - Clinical/Medical & Regulatory Function  in Biocon Limited in  Bangalore for (7-12) years of experience. Apply Now!