Provide quality oversight of all outsourced operations related to raw material, in-process, and finished good production activities, including warehousing and distribution.
Be the internal expert for the us payer market, to include new policy development, alternative reimbursement models and other changes that could alter the payer/pharma landscape.
Supporting department heads and teams to ensure accurate cost controls, expenditure reporting, and enhancement of financial understanding and knowledge.
Lead commercial launch team, comprised of functional brand team members such as managed markets, sales, commercial operations, distribution, finance, regulatory, medical affairs, and patient advocacy.
Head medical affairs operations for all programs and assure high quality achievement of corporate goals, and enable successful product launches and post-launch support.
Ownership of the technology portfolio related to finance, legal, investor relations, and human resources, ensuring interoperability and responsiveness to the technology needs of these groups.
Oversee monitoring of all relational database implementations in conjunction with the infrastructure team to ensure proper security, efficient utilization, allocation and user access.
Plan, communicate and implement the surveillance of the statistical programming activities performed by a CRO. Provide statistical programming support for Data Monitoring Committee charters and associated statistical programming deliverables.
Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed. Participate in departmental development activities including SOP and Work Instructions development.
The Analytical Manager is responsible for leading the analytical method development, validation, and transfers at the clinical stage. The individual is also responsible for the analytical review and approval of methods, protocols, and reports for validation and stability studies.
Review and validation of clinical study reports (CSRs); thorough understanding the connection between the data and the CSR. Lead or support assigned study level activities for 1 or more clinical studies with minimal supervision; may lead or co-lead a study.
Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance.
Leads North American based clinical trials. May manage multiple small, early phase programs. Collaborates on global clinical trials. Reviews and approves study related plans generated by Clinical CROs and vendors.
Create and maintain regulatory submissions tracker and timelines, scheduling team meetings, agenda, meeting materials, minutes and follow-up with team members on action items.
Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, executing submissions, serving as the regulatory lead on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.
