Regulatory Affairs Specialist III

Location
Duarte, California
Salary
Competitive
Posted
November 19 2021
Ref
10013891
Position Type
Full Time
Organization Type
Healthcare/Hospital
About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

The Regulatory Affairs Specialist III is responsible for supporting the activities relating to all City of Hope (COH) sponsored INDs/IDEs and investigator initiated INDsfor Phase I/II clinical trials in the setting of an academic research organization. The individual will assist in the development and implementation of regulatory strategies for interacting with regulatory agencies and may act as a liaison with the FDA for specific projects. This individual will serve as the regulatory project lead in regulatory submissions, to include INTERACT, Pre- and Initial IND Filings and any corresponding Amendments .

Key Responsibilities include:

Under the direction of the Director of OIDRA, the Regulatory Affairs Specialist III will hold responsibility for the writing, review, compilation and subsequent preparation of INTERACT, Pre and Initial IND filings, to include corresponding amendments to same. In this capacity, the Specialist III will direct and review the work of regulatory team members assigned to a given project. The Specialist III will consult with his/her Director, as needed, to resolve outstanding issues and to ensure timely and compliant regulatory filings.

The following are essential job accountabilities:

Under supervision of Director, OIDRA, will hold responsibility for Pre-IND and Initial IND/IDE filings. Responsibility will encompass compilation of data, authoring of sections (as required), and accuracy/completeness of filing.

Will supervise assigned staff in completion of regulatory filings, ensuring that workload assigned is being completed in a timely manner.

Will advise assigned staff on issues pertaining to regulatory compliance, from the perspective of the FDA and any applicable external agency.

Will work on an ongoing basis with other team members to ensure timely completion of other IND/IDE filings, as required, to include IND/Drug Master File Annual Reports, Protocol Amendments, Information Amendments and Safety Amendments. May be requested by Director to oversee certain types of filings, e.g. Safety Reporting, when the volume necessitates a single point of contact.

Attend departmental meetings, advising team of status of projects assigned. When applicable, will request additional assistance to ensure timely completion of submissions.

In conjunction with Director, will work to develop Standard Operating Procedures that are compliant with applicable regulatory requirements and COH guidelines.

Provide assistance and support to Principal Investigators and other applicable parties, e.g. Pharmacy, Pharm/Tox, to ensure timely and accurate submissions of regulatory filings.

Able to perform multi-tasks to ensure timely completion of filings.

Must possess good communication skills; able to relate findings in a manner that is clear and concise (both written and verbal).

May assist with preparation of grants and papers with respect to their interaction with regulatory agencies.

Provides guidance to physicians, CPRMC, PRC and IRB in the interpretation of GCP, IRB, and FDA guidelines.

In conjunction with Director, will assist with internal and external regulatory inspections. In the absence of the Director, will assume lead position if requested by Sr. Vice President.

Basic education, experience and skills required for consideration:

Minimum Education

Requires a Bachelor's degree in a scientific discipline or equivalent.

Minimum Experience

A minimum of 8 plus years with a Bachelors, or 7 plus years with a Masters, or 6 plus years with a PhD.

Up to date familiarity with regulations pertaining to INDs experience as a medical writer.

Computer skills including Microsoft Windows, Word and Excel, Adobe Acrobat.

Required Courses/Training

Science courses required; medical writing, pharmacology courses preferred

Requirements:

Must possess excellent written/editorial, interpersonal, verbal communication, and computer literacy skills.

Must communicate technical information in a clear, concise manner.

Ability to monitor and train other employees.

Ability to master content across all clinical research areas.

Previous supervisory experience preferred.

Preferably has experience with Adobe.

Preferred Education

Masters with 7 plus years related experience or Ph.D. with 6 plus years related experience (science discipline preferred).

Preferred Courses/Training

Regulatory Affairs coursework.

Pref. Certification/Licensure

Certification in Regulatory Affairs preferred.

Preferred Field of Expertise

Regulatory Affairs, Medical Writing, or relevant scientific field.

Skills: Other

Background in oncology, cellular and gene therapy, preclinical study design and/or medical device is a plus.

Additional Information:
  • To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.


City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

  • Posting Date: Nov 19, 2021
  • Job Field: Research
  • Employee Status: Regular
  • Shift: Day Job

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