1 Regulatory Specialist Job in Hackenack, NJ
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HMH HOSPITALS CORPORATION is Hiring a Regulatory Specialist Near Hackenack, NJ
Our team members are the heart of what makes us better.
At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community.
Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.
The Regulatory Specialist is responsible for ensuring compliance with Federal, State, and Local Regulations, Good Clinical Practice (GCP), and Institutional policies and procedures as it relates to all regulatory aspects of assigned clinical trials conduct. This role will serve as a regulatory liaison to internal and external investigators, sponsors, collaborating divisions, departments and institutions, and Institutional Review Boards (IRBs), Data Safety and Monitoring Boards, Biosafety committees, Laboratory facilities, and external regulatory agencies. This role is the primary point of contact for all regulatory matters concerning all assigned clinical trials and is responsible for the scheduling, preparation for and facilitation of conduct of all internal and external audits, as well as ensuring ongoing compliance of study-related documentation throughout the clinical trial lifecycle for all assigned clinical trials.
Qualifications:
Education, Knowledge, Skills and Abilities Required:
- BA/BS diploma/degree in science or healthcare field OR minimum of 2 or more years of experience in a related area with High School diploma, general equivalency diploma (GED), and/or GED equivalent programs.
- Strong attention to detail and customer service focus.
- Excellent communication, organizational, presentation, documentation, and interpersonal skills.
- Ability to work independently, and in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and/or Google Suite platforms.
Education, Knowledge, Skills and Abilities Preferred:
- Minimum of 2 or more years of extensive experience in research that includes Clinical Research, Regulatory, Auditing, and interactions with an IRB..
- Education on human subject research and GCP.
Licenses and Certifications Preferred:
- Certified Clinical Research Professional or Certified Clinical Research Coordinator or Society of Clinical Research Associates Certification.
If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!
Job Summary
Full Time
Hospital
$61k-80k (estimate)
06/19/2024
06/19/2024
hackensackumc.org
EDISON, NJ
7,500 - 15,000
1888
NGO/NPO/NFP/Organization/Association
ROBERT CHARLES GARRETT
$1B - $3B
Hospital
Related Companies
About HMH HOSPITALS CORPORATION
HackensackUMC is a research and teaching hospital that provides inpatient and outpatient services.
The job skills required for Regulatory Specialist include Clinical Trial, Collaboration, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Specialist positions, which can be used as a reference in future career path planning. As a Regulatory Specialist, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Specialist. You can explore the career advancement for a Regulatory Specialist below and select your interested title to get hiring information.
If you are interested in becoming a Regulatory Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Regulatory Specialist for your reference.
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Quotes from people on Regulatory Specialist job description and responsibilities
The regulatory specialist creates and maintains regulations for testing processes, the development phase, how production operates and the marketing and distribution for new products.
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Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
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Certified regulatory affairs specialists typically collect and review marketing, legal, regulatory and licensing documentation, case files, studies, reports, etc.
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Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
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works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Regulatory Specialist jobs
Entry-level regulatory affairs professionals must have a bachelor’s degree.
02/23/2022: Chico, CA
Successful regulatory specialists are excellent writers, as they must write details and accurate reports for the evaluations they perform.
02/24/2022: Newport News, VA
Earn Regulatory Affairs Professionals Society certifications.
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On successful completion of the program, graduates can take up roles such as regulatory affairs specialists.
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At conferences and forums, specialists develop their existing knowledge and learn about emerging regulations, standards, and guidance documents.
04/28/2022: Lowell, MA
Step 3: View the best colleges and universities for Regulatory Specialist.
