Find More Than 10K+
United Kingdom Jobs

The Associate Manager, Clinical Transparency will be responsible for owning the redaction and anonymization of clinical trial documents required for public disclosure. We assume the Clinical Transparency professional will partner with internal and external collaborators for the planning, initiation, and delivery of redacted documents in support of the EU Clinical Trial Regulation (EU CTR), ClinicalTrials.gov, and Publications and Regulatory Authority Transparency Submissions (e.g., EMA Policy 0070, Health Canada PRCI), manuscript publications, clinical trial registries, and data sharing. We feel the Associate Manager will be tasked to demonstrate knowledge of global transparency regulations and Regeneron SOPs to work independently on assignments of moderate complexity and ensure compliance.

IN THIS ROLE, A TYPICAL DAY MIGHT INCLUDE:

• Manages and facilitate redaction projects of clinical trial documents against planned timelines, in accordance to REGN SOPs and regulatory requirements
• Monitors and tracks document redaction requests and develops timelines for delivery
• Leads review and approval workflows and liaises directly with project team members to deliver redacted documents against planned timelines
• Ensures accurate and consistent redaction of clinical trial documents to support EU CTR, ClinicalTrials.gov, and Publications
• Collaborates with Regulatory Operations to ensure the publishing of redacted documents in Regulatory Document Management System

THIS ROLE MIGHT BE FOR YOU IF:

• You have a strong understanding and experience in clinical transparency and disclosure activities on a global setting (ICH/GCP and Regulatory Guidelines)
• You are a compelling communicator with the ability to translate sophisticated messages to a variety of audiences.
• You can build strong working relationships in a diverse range of team environments
• You are able to work in ambiguity and take initiative to complete tasks with minimal oversight

To be considered, we expect applicants to have a Bachelor's degree and at least three years of relevant industry experience within transparency or disclosure within the Life Science industry.

#GDRAJobs #LI-Remote

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.$92,500.00 - $150,900.00