About Employer:A $17B med device company. A medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.
- Utilize technical clinical affairs skills to propose strategies for clinical development plans and sophisticated research issues.
- Provide strategic input and technical mentorship on clinical requirements to development teams.
- Manage and execute pre-approval clinical activities.
- Provide clinical input to product lifecycle planning.
- Monitor impact of changing regulations on submission strategies and update stakeholders.
- Ensure team members, and internal and external partners/contractors understand and work towards the goals and that the priorities and measures of those goals are understood and accepted.
- Facilitate information exchange among team members to overcome obstacles and build teams.
- Support and review regulatory submissions as required.
- Contribute to applicable submissions (IDE, PMA, CER, etc.), reports, responses to regulatory authorities and audit/inspection activities.
- Develop plans for product post-marketing approval requirements.
- Establish and maintain relationships with alliance partners, external companies, investigators and key opinion leaders to optimize performance on clinical trial activities.
- Review and approve required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations.
- Collaborate with Corporate Medical Affairs on developing processes and internal standards. Travel between BD offices in the US (RI, NJ, IL).
- Other projects assigned.
- Minimum B.S. Science, engineering, or other relevant technical degree with minimum 5 years of leadership experience in clinical affairs. M.S. degree preferred.
- Broad knowledge/experience clinical trial execution
- Broad knowledge and experience with clinical affairs regulations and implementation.
- Effectively manage complex project schedules.
- Demonstrated track record of managing multiple parallel studies from pre-market planning through completion with resulting successful marketing authorization, publications, and establishment of broadened indications and claims for medical devices.
- Thorough knowledge of medical products quality system principles and GCP concepts, practices and procedures.
- Ability to maintain or create a team-oriented, collaborative environment.
- Ability to work independently with confidence, resolve conflicts, and negotiate with a “win-win” approach.
- Capacity to work in a matrix/team environment with prior significant experience supervising regulatory affairs professionals.
- Solid skill in written and oral communications.
- Positive energy and passion to work in a multi-task environment.
- Maintaining existing professional and scientific relationships with professional societies and governmental regulatory agencies.
- Ability to travel as needed, up to 30%.