Prepare all regulatory documents including IND, NDA, annual reports, and meeting briefing books Write day to day communication with the regulatory agencies Implement regulatory strategies (decided by the team) and incorporate those in the preparation of above regulatory documents and interactions Collaborate with the team to determine the regulatory strategy based on clin

Prepare and/or review documents for submission to the US FDA (Module 2 and Module 3 documents, Annual Reports, Orphan Drug Applications) Organize and/or review documents for submission to foreign regulatory agencies (CTA, IMPD, NDS) Assess regulatory impact for any changes in the manufacture of drug products or drug substances Create regulatory submission strategy for pro

Support successful execution of one or more clinical studies from study planning to close out Participate in vendor selection and contracting Oversee vendor performance and review vendor deliverables Contribute to the management of study finances by reviewing vendor contracts, budgets, and invoices Aid in the development of study timelines with internal study team and ext

Oversee the operational aspects of clinical trials Assist in project planning, timeline preparation, preparation, and review of study plans Manage CRO interactions and sponsor oversight of operational functional activities Prepare and review clinical documentation and other essential study documents/plans Contribute to protocol, strategy development, Clinical Study Report

Plan and communicate with cross functional areas to ensure proper execution and conduct of assigned clinical trials Serve as primary contact and resource for CRO, vendor personnel, and internal team members Oversee and manage CROs, consultants, and vendors Supervise and oversee clinical studies ensuring they are conducted in compliance with the agreed study plans through

Analyze production/processing problems and initiate project definitions to resolve them Ensure timely and within budget completion of the projects as assigned Evaluate the feasibility of conceptual projects and prepare detailed analysis (time/cost for completing the projects) Verify that assigned projects are in compliance with State, Federal, and local codes which encomp

Identify, develop, and maintain relationships with thought leaders Collaborate cross functionally to contribute to scientific communications/publications plan Develop a medical education plan by identifying gaps in current knowledge and apply deep therapeutic area insights to action Lead MSLs in delivering timely, objective, scientific, and economic information/education

Lead the statistical and programming activities in ISS/ISE to support BLA Perform, advise, and review protocol development, sample size calculation, protocol, and CRF review Ensure the accurate programming of SAS clinical data extracts and data displays Provide statistical input into and perform review of SAPs, table shells, programming/table specifications, TLFs, and sta

Develop an understanding of the regional landscape including specialties involved in care of patients Generate and execute tactical regional plans to provide need based, value added support of the medical/scientific community in line with company goals Support clinical development initiatives Collaborate with key internal/external stakeholders on Medical Affairs initiativ