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REGULATORY AFFAIRS SCIENTIST

Requisition Number::  170915
Date:  May 17, 2022
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

This Position is Fully Grant Funded

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

 

Job Title: Regulatory Affairs Scientist               

                                   

Primary role:

 

Under the direction of the Director/Associate Director of Regulatory Affairs, this position involves providing guidance and assistance to Duke University investigators and study teams who need US Food and Drug Administration (FDA) oversight for their research projects. It encompasses working on FDA applications for a diverse portfolio of products with a focus on pre-market submissions for drugs, biologics, devices, and tobacco products. Projects can also entail meetings with FDA and helping to ensure compliant maintenance of effective FDA applications. Other duties will include training and assistance for investigational staff.

 

The RA Scientist will liaise with several groups, including principal investigators, research fellows and regulatory coordinators. He/she will also provide operational and compliance guidance to these groups.

 

Essential tasks/responsibilities:

 

Tier 1

In conjunction with other members of the RA Staff and/or Management:

 

  • Author and edit initial IND/IDE/ITPs and various maintenance applications including amendments, annual reports and safety reports. As applicable, assist with the preparation and submission of FDA meeting- related documents. Perform duties involved in the organization, documentation and compilation of regulatory documents.
  • With direction, provide regulatory advice to Duke sponsor- investigators and their research teams by explaining and interpreting regulations and encouraging adherence to FDA guidance. Work to identify potential problems and/or inconsistencies and make corrections as appropriate. Encourage best practices among all Duke investigators.
  • Act as an FDA contact for Duke investigators and help resolve issues in a timely manner.
  • Support the DUHS IRB by reviewing PI-initiated research studies and evaluating them for regulatory issues.
  • Attend regulatory affairs training courses and become familiar with appropriate regulations and guidance documents in order to provide direction to investigators desiring regulatory support.
  • Work with ORAQ staff to create and maintain best practices workshops related to regulatory issues including INDs and IDEs. Provide training and support material for all regulatory documents listed above.
  • Work with ORAQ staff to mentor other professionals through the ORAQ Training Program/Workshops, as applicable.
  • Along with other ORAQ staff and with direction, work on ORAQ initiatives in the education, operations, or collaboration area.
  • Assist with new and ongoing research projects related to regulatory issues, with the objective to publish the research findings.

 

Tier 2

With minimal oversight by management or independently:

 

  • Author and edit initial IND/IDE/ITPs and various maintenance applications including amendments, annual reports and safety reports. Complex projects may include considerations for commercialization, manufacturing, and/or pre-clinical animal studies. As applicable, assist with the preparation and submission of FDA meeting request documentation. Perform duties involved in the organization, documentation and compilation of regulatory documents.
  • Provide regulatory advice to Duke sponsor-investigators and their research teams by explaining and interpreting regulations and encouraging adherence to FDA guidance. Work to identify potential problems and/or inconsistencies and make corrections as appropriate. Encourage best practices among all Duke investigators.

 

  • Act as an FDA contact for Duke investigators and help resolve issues in a timely manner.
  • Assist with the development, coordination, and implementation of complex regulatory projects.
  • Mentor other ORAQ RA staff on regulatory projects.
  • Stay abreast of evolving regulatory trends that are likely to impact study teams.
  • Support the DUHS IRB by reviewing PI-initiated research studies and evaluating them for regulatory issues.
  • With direction, develop and deliver regulatory affairs training courses on new and relevant regulations and guidance documents in order to provide direction to investigators desiring regulatory support
  • Work with ORAQ staff to mentor other professionals through the ORAQ Training Program/Workshops, as applicable.
  • Participate in ORAQ initiatives in the education, operations, or collaboration area. May lead multiple projects in that area and provide more strategic oversight of that work.
  • May serve as team lead or manager of other RA staff.
  • Assist with new and ongoing research projects related to regulatory issues, with the objective to publish the research findings.

 

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

 

Education/training:

 

Required: Bachelor’s degree

Preferred: PhD in Biology, Chemistry or Life Sciences or equivalent doctorate (e.g. MD, PharmD).

 

 

Experience:

 

Required:

  • 3 years of experience in a laboratory or regulated field.

Preferred:

  • Experience working in or with a Regulatory Affairs Department.

 

 

OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE                

Skills:

Required:

  • Strong organizational and time management skills, and the ability to handle a multitude of tasks
  • Attention to detail
  • Ability to handle multiple projects simultaneously
  • Able to work effectively independently or in a team environment
  • Ability to interact well with employees at all levels
  • Strong organizational skills
  • Excellent verbal, written, and interpersonal skills
  • Possess good problem solving skills

 

Special competencies/credentials:

           

Required: None

            Preferred: None

 

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

 

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

 

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

 

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

 


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