Medasource
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Regulatory Affairs Specialist
6-month contract-to-hire
Philadelphia, PA (hybrid flexibility)
ASAP start
POSITION SUMMARY:
The Regulatory Affairs Specialist C functions independently with minimal supervision on complex protocols. The Regulatory Affairs Specialist C reviews and creates core documents (protocols, Informed Consents, investigator brochure, Monitoring Plans, etc) and reports, and is responsible for the preparation of health authority submissions including meetings, new IND/IDE applications, and maintenance for these applications by and facilitating all communications with the reviewing entities (including FDA, IRB, and other federal/state/local agencies, per application). The Regulatory Affairs Specialist C will need to be aware of legal agreements needed and/or planned and ensure appropriate information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA, via electronic means, where available and feasible.
Support faculty sponsors and OCR Regulatory leadership on topics related to GXP and translational research.
DUTIES:
15% Reviews and creates core documents (protocol, informed consent, investigator brochure, monitoring plans, etc.) and reports.
20% Prepare health authority submissions including meetings, new IND/IDE applications, and maintenance of these applications. Facilitate all communication with reviewing entities.
20% Ensure high quality of the research projects assigned and documentation is current and complete.
10% Review relevant safety information, obtain feedback from other parties, and identify potential impacts to other protocols/staff.
5% Inspection Readiness and facilitate audits of assigned projects.
2.5% Aware of legal agreements needed and/or planned and ensures appropriate information is included and addressed.
2.5% Assist in creating new operating procedures, work instructions, and templates.
5% Monitor regulatory news related to assigned activities, translate into operational changes as needed.
10% Provide guidance and training to Penn faculty sponsors and staff.
5% Assist OCR Regulatory leadership with metrics and reports as assigned.
5% Other duties as assigned
CREDENTIALS: Bachelor’s degree and 5-7 years research experience required; at least 2 year’s regulatory experience preferred. Associated research credentialing (RAC, CCRP, CIP, etc.) are highly recommended or preferred to be completed within 1 year of employment.
COMPETENCIES:
· Problem-solving and critical thinking abilities
· Collaboration.
· Communicates effectively (verbal and written).
· Scientific knowledge and research design.
· Thorough and demonstrated knowledge of Regulatory Framework and GXPs
· Initiative and self-driven
· Detail oriented.
· Strong Organization & Time management.
· Flexible and able to multi-task
· Intermediate/expert level of function in all of the Microsoft Office applications, as well as applications for team interconnectivity such as Microsoft Teams, Zoom, WebEx, etc. Knowledge and/or experience working with web-based e-regulatory document management systems such as Veeva Systems products, the Electronic Common Technical Document (eCTD), etc. is a plus.
For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
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