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The Medical Device Innovation Consortium (MDIC) is the first-ever 501(c)3 public-private partnership created with the sole objective of advancing medical device regulatory science for patient benefit. As a membership based organization, MDIC brings together representatives of the Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Medicare & Medicaid Services (CMS), industry, non-profits, and patient organizations to improve the processes for development, assessment, and review of new medical technologies. Our work is unique and complementary to trade associations such as the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA). Members of MDIC share a vision of providing U.S. patients with timely access to high-quality, safe and effective medical devices.
In September 2016, the FDA awarded a grant for the National Evaluation System for health Technology (NEST) Coordinating Center (NESTcc) to MDIC. The mission of NESTcc is the creation of structures for responsible sharing and efficient analysis of real-world evidence to inform and empower patients, accelerate medical device innovation, and improve healthcare outcomes. Stakeholders across the medical device ecosystem stand to benefit from improved use of real-world evidence (RWE) generated in the routine course of care.
The Operations Manager will be responsible for supporting the establishment of the operational structure of NESTcc and leading activities to integrate current MDIC operations with needs of the NESTcc project as it grows. Areas of responsibility include information technology, finance and grant compliance, award lifecycle management, and legal coordination. This position is for a self-motivated individual who is a highly organized, with excellent judgment for managing competing priorities effectively. The Operations Manager, NESTcc will report to the Deputy Director, NESTcc and work closely with the MDIC Director of Operations.
Objectives and Responsibilities:
Finance and Grant Compliance
- Manage the proper documentation and approval of all expenses and contracts per OMB uniform guidance, FDA grant guidelines, and MDIC finance and administrative policies.
- Track project budgets, grant documents, contracts, and expenses to ensure alignment.
- Responsible for quarterly and annual financial grant reporting.
- Administer budget preparation, development, tracking, and amendments when required.
- Manage compiling and providing routine reporting obligations to various stakeholders.
- Provide program support such as recommending and implementing improved work processes, assisting with special projects and initiatives, and overseeing supply needs.
- Review and process all related expense reports, obtaining the necessary approvals.
Contracts and Governance
- Support the establishment of agreement mechanisms needed to support NESTcc including subcontracts, subawards, participation agreements, non-disclosure agreements, and memoranda of understanding to develop an efficient and effective structure for NESTcc.
- Responsible for the full lifecycle of all subawards and subcontracts for the NESTcc, including ensuring subawardee and contractor compliance with all award and MDIC policies.
- Support the development of Requests for Proposals (RFPs) and solicitations in alignment with funding requirements, MDIC policies and legal review.
- Coordinate legal counsels in the development, negotiation, and execution of project contracts and subawards in order to ensure compliance and proper review in accordance to MDIC bylaws and policies and grant requirements.
- Drafts and enforces corrective actions for noncompliance in consultation with legal counsel.
- Develop NESTcc standard templates, as well as NESTcc policies and procedures.
- Manage conflicts of interest and confidentiality processes including establishing an IT infrastructure.
- Ensure project and staff compliance of MDIC administrative and personnel policies.
- Work with MDIC’s outside IT providers to ensure firm’s technology needs are addressed and work to develop an IT solution that supports NESTcc requirements.
- Manage the organization and maintenance of shared organizational files.
- Bachelor’s degree is required, advanced degree preferred
- At least 5-8 years of experience in a management position with a nonprofit or in the MedTech/Life Science industry
- Experience identifying and managing relationships with professional services representatives
- Experience developing process and materials to support broad business initiatives
- Experience working with virtual teams is a plus
- Some minimum local travel might be required
- Experience as a paralegal or serving as a liaison with legal teams
- Experience with Federal grants and contracts
- Maintain a positive, collaborative, professional work environment through effective communication of information.
- Strong knowledge of administrative procedures, federal grant requirements, and contract development.
- Forward thinking with the ability to anticipate the implications and consequences of situations and take appropriate action to be prepared for possible contingencies.
- Embracing of the mission, with emphasis on developing the consortium and NESTcc.
- Ability to interact with employees, visitors, shareholders and others with ease and grace, adopting an “open-door” policy for all with strong multitasking abilities.
- Experience supporting the development of processes and materials to support broad business initiatives.
- Use and maintain strict confidentially, discretion, and judgment in dealing with confidential, sensitive and controversial issues in all aspects of work.
- Confidence, flexibility, emotional intelligence.
- Ability to remain calm under pressure.
- The employee will report directly to the Deputy Director, NESTcc
- Works closely with the NESTcc Executive Director and Project Managers to support overall goals and objectives.
- Works closely with MDIC Director of Operations.
Minimum Education Required
How To Apply
Please send resume and cover letter to email@example.com. Include the position title in the subject line of the email. Resumes will be reviewed on a rolling basis until the position is filled. No phone calls please. Only qualified candidates will be contacted by MDIC.