Regulatory Operations Specialist
We are currently searching for a skilled professional to join a well-known client’s team as Regulatory Operations Specialist in Bridgewater, New Jersey. The Regulatory Operations Specialist position is responsible for performance of the medical services portion of the NDA annual report. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Overseeing and managing the timely assembly of the Clinical Data Template for their assigned products
- Responsible for ensuring the process is followed in compliance with all appropriate SOPs.
- Quickly gain familiarity with internal clinical databases such as Crystal, PRISMA, CTMS, and clinicaltrials.gov to gather all of the relevant information to assemble the Clinical Data Template
- May also act as quality control viewer for CDTs prepared by other individuals
- A minimum of 3 years pharma or biotech industry experience in clinical research or medical affairs
- Track record of successfully managing multiple complex projects from start to completion
- Strong attention to detail is a must
- Project management and organizational skills
- Working knowledge of clinical development, FDA regulations and ICH/GCP guidelines
- Understanding of database concepts
- Knowledge of industry standards and practices preferred
- Excellent interpersonal and communication skills, including medical terminology
- Bachelor’s Degree in business or science area
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.