Associate Director/Project Manager

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.

Responsibilities:

• 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.

Education/Experience:

• 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%.