Research Regulatory Program Manager

3+ years

Not Disclosed

Remote, USA

10 Aug. 16, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Research Regulatory Program Manager (RPM)

Overview:

The Research Regulatory Program Manager (RPM) is a pivotal role within the Research team, responsible for ensuring regulatory compliance and ethical standards across research projects. The RPM develops and maintains strong working relationships with team members across various functions and levels within the organization. As a key knowledge leader for regulatory compliance, the RPM supports research projects by safeguarding FDA and HHS compliance, overseeing protocol review, developing informed consent documents, coordinating with IRBs, contributing to regulatory submissions, and performing other related duties.

Key Responsibilities:

Regulatory Compliance: Oversee the Research Regulatory Compliance Program within the Research Quality Assurance and Compliance (QA&C) team. Ensure adherence to regulations such as IDE, 510k, and De Novo, and assist in drafting supporting documents for regulatory submissions in collaboration with Regulatory Affairs.
IRB and Device Reporting: Manage external IRB submissions, device reporting, and interact directly with clinical trial sites throughout the study lifecycle.
Collaboration: Work closely with Business Unit teams to provide input on product development plans, focusing on meeting regulatory needs while considering clinical resources, study prioritization, and product strategy.
Expertise: Maintain a high level of knowledge in areas such as FDA and HHS regulations, GCP, specimen use, and research ethics. Stay updated with relevant SOPs, industry standards, and internal policies.
Regulatory Updates: Evaluate the impact of new regulatory requirements, disseminate key knowledge, and implement new regulations as necessary.
Sponsor Oversight: Ensure sponsor responsibilities for research are upheld, including maintaining oversight of contract research organizations.
Team Management: Plan and lead team meetings, including scheduling, agenda preparation, meeting minutes, and follow-up on action items.
Travel: Some travel may be required.

Qualifications:

Education:
- Bachelor’s degree in a scientific discipline or equivalent, with three years of related work experience.
- Alternatively, a High School Diploma or equivalent with five years of clinical research, medical, healthcare, or pharmaceutical experience, and three years of related regulatory work experience.
Skills:
- Strong teamwork and communication skills.
- Excellent written and verbal communication abilities.
- Ability to prioritize, organize, and multitask effectively.
- Detail-oriented with the capacity to perform critical reviews of complex documents.

Physical Requirements:

Lifting Requirements: Light work, including exerting up to 20 pounds of force frequently.
Physical Activities: Stationary positioning, moving, operating equipment, ascending/descending, communicating, and observing.

Equal Employment Opportunity:

We value diversity and inclusion and are committed to being an equal opportunity employer. We prohibit discrimination and harassment based on any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy, disability, or any other basis protected by law. We provide reasonable accommodations for religious practices, mental health needs, and physical disabilities as required by applicable law.

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Research Regulatory Program Manager

Job Description

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