"Work across multiple disciplines within and outside Regulatory Affairs to drive departmental and project objectives.
Responsibilities:
- Person will be responsible for coordinating the posting of registration and disclosures on clinicaltrials.gov, EudraCT and other registries for company-wide studies. This comprises supervision of the vendor as well as coordination of company internal processes to ensure compliance with all relevant legal obligations (primarily clinicaltrials.gov and EudraCT disclosure).
- Database proficient with registrations and disclosures preferred.
- Has the ability to work cross-functionally and meet required deadlines.
- Ensures trial disclosure is in compliance with applicable regulations globally.
- Develops and maintains strong internal relationships across all levels of the clinical organization.
- Escalates issues to management in an expedient manner.
- Continually train and remain in compliance with all current industry requirements as they relate to clinical trial disclosures.
- Reviews of clinical and regulatory documents and regulatory submissions for data accuracy, consistency, formal quality and readability, resolving identified issues in collaboration with authors in a productive fashion
- Coordinates all clinical disclosure activities, acting as primary intermediary between the disclosure vendor and contacts 30
- Works with contacts to identify and resolve compliance gaps 30 •Supports continual improvements by evaluating disclosure business process, suggests and implements improvements to enhance compliance, documents processes and trains relevant personnel 20
- Maintains disclosure trackers and produces metrics reports for management 10
- Maintains product information for use in disclosure activities 10
Requirements:
- Bachelor’s degree required
- At least 3 years working in the pharmaceutical industry in an R&D environment.
- Solid knowledge of clinical trial transparency principles, preferably on an international level
- Strong attention to detail and the ability to work as a part of a team across multiple departments
- Strong communication and influencing skills "
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus
Kind Regards,
Neomi Nieves
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Inc. 5000 | 2007 – 2014
Main: 732–549–2030 x140
Direct: 732–902–2064
Website: www.irionline.com
