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SalaryAdecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.
The anticipated wage for this position is between $88 and $89.22. Hourly wage may depend upon experience, education, geographic location, and other factors.
Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria
This role will require direct experience in US FDA Advisory Committee (ADCOM) Preparation. Experience in Immunology products is preferred, but any ADCOM experience will be considered.
Education and Experience:
• BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred.
• At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D, including at least 5 years of relevant Regulatory Affairs experience (regionally and/or global).
Advisory Board Experience, The Role will pre-team and or presented regarding a current Immunology Product The expected advisory committee meeting in October. A possible meeting in Washington DC, which may require travel
Top Must Haves: • Prepped for the advisory committee, FDA is giving attention to the product, so you need to prep slide for questions that they may have, • Understanding how the FDA will ask their questions • Prep the team on how they should present and answer – cross-functional leadership teams, Medical Directors lead statisticians, lead of R&D • Minimum 5 years of relevant Regulatory Affairs experience (regionally and/or global) • This role will require direct experience in US FDA Advisory Committee (ADCOM) Preparation
Nice to Have/ Preferred: • Previous regulatory experience as a: Consultant, Director, Global Reg Affairs Specialist
Pay Details: $88.00 to $89.22 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adeccousa.com/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
