Research Regulatory Program Manager (REMOTE)

Overview

JOB DESCRIPTION

The Research Regulatory Program Manager (RPM) position works with the Research team to actively support study regulatory needs and ethical compliance. The RPM develops and maintains collaborative and cooperative working relationships with team members across different functions and at different levels within the organization. The RPM is a key knowledge leader for regulatory compliance within the Research team and serves in an operational role to directly support research projects through safeguarding FDA and HHS compliance, protocol review, informed consent development, IRB coordination, contributing to regulatory submissions, and other duties as assigned.

Sponsor- Level Experience Required.

Responsibility

• Maintains overall responsibility of research regulatory compliance for the Research team with direct oversight of the Regulatory Compliance Program within the Research Quality Assurance and Compliance team (QA&C).
• Supports the regulatory submission process and ensures compliance with related regulations (e.g. IDE, 510k, De Novo, and drafting supporting documents for regulatory submission in conjunction with Regulatory Affairs as needed). Knowledgeable with external Institutional Review Boards (IRBs) submissions, device reporting, and comfortable working directly with clinical trial sites throughout a study’s life cycle.
• Collaborates with Business Unit teams by providing input into product development plans with a focus on meeting regulatory needs while considering clinical resources, study prioritization, and product strategy.
• Maintains a high level of expertise in assigned areas (e.g., applicable FDA and HHS regulations, NY Wadsworth, GCP, specimen use, research ethics, etc.), including familiarity with applicable SOPs, industry standards and other internal policies related to the conduct of research.
• Evaluates the impact of new regulatory requirements and disseminates key knowledge while providing recommendations and actions plans as relevant. Directs implementation of new regulatory requirements as they arise.
• Ensures sponsor responsibilities for research are being upheld. This includes both internal and external oversight, such as maintaining sponsor oversight while using contract research organizations.
• Plans and leads team meetings, including scheduling meetings, preparing agendas, developing meeting minutes, and following up on action items.
• Some travel may be required.
  
  
  

Qualifications

• Required Education/Credentials
• Bachelor’s degree in a scientific discipline or equivalent, and three years of related work experience.
  
  
  

OR

• High School Diploma or equivalent, along with 5 years of clinical research, medical, healthcare, or pharmaceutical experience, and 3 years of related regulatory work experience.
• Required Experience/Skills
• Must be able to work and communicate well within a team setting.
• Must have good written and verbal communication skills.
• Must be able to prioritize and organize work.
• Must be detail oriented and able to perform critical review of complex documents.
• Must be able to multitask.
  
  
  

Physical Requirements

Lifting Requirements – light work or exerting up to 20 pounds of force frequently. Physical Requirements – stationary positioning, moving, operating, ascending/descending, communicating, and observing. Use of equipment and tools necessary to perform essential job functions.

EEO

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants’ and employees’ religious practices and beliefs, as well as any mental health or physical disability needs.