Accordance Search Group is Hiring an Associate Director/Project Manager Near Franklin, NJ
About EmployerA $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 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.