Clinical Transparency Specialist

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

The Clinical Trial Transparency (CTT) Specialist will work with the Clinical Trial Disclosure (CTD) Team and be responsible for assembling information for protocol registrations, updates and results postings on ClinicalTrials.gov and other applicable websites as per Clinical Trial Registration & Results Disclosure requirements worldwide. The CTT Specialist will consult representatives from Global Development to ensure accuracy and consistency across registries, respond directly to comments from government registry operations staff as needed and notify relevant functions of public release. CTT Specialist will provide functional groups guidance on internal public disclosure processes and global regulatory requirements for registrations and results disclosure as needed.

Job Duties:

• Collaborate with Study Teams and Collaborators to develop and facilitate approval of Registry and Reporting content

• Assist with results reporting to global databases as required (eg, CT.GOV, EudraCT and ROW National Registries)

• Assists in the development of job aids, work instructions, training materials and procedures, as needed

• Consults with relevant team functions within Global Development, such as, Clinical Operations, Medical, Biostatistics, Regulatory Affairs, and Medical Writing to review protocol information to obtain accurate, appropriate information for public disclosure. Outlines requirements from multiple international disclosure laws and guidance and internal processes and interprets requirements as appropriate for the type of study, and recommends information to be disclosed.

• Enters and releases the initial protocol information and revised protocol information on clinicaltrials.gov and other websites as required by international law/guidance Policy

• Interprets rapidly changing domestic and international laws and requirements for clinical trial results disclosure. Consults with relevant team functions to assimilate the required results data fields for posting. Ensures information is entered in appropriate databases and reviews information for accuracy. Releases information to the public and responds to government agencies to resolve issues if needed.

• Ensures sponsored studies are disclosed according to applicable laws, regulatory requirements and policies

• Archives registration and results posting documentation

• Communicates registrations and results dates and links to relevant stakeholders

• Updates existing registries with changes in ongoing clinical trial status including recruitment status, protocol amendments, site updates and actual dates

• Monitors and tracks existing clinical trial registrations for future results posting and notifies appropriate team members of upcoming deadlines

• Serves as a key contributor to international clinical trial disclosure processes

Requirements:

Education

• Bachelor's degree (advanced degree preferred) in science or a health profession

Experience

• Minimum of 2+ years of relevant industry experience

• Understands the legal/regulatory requirements and guidelines with regard to clinical trial disclosure, as well as ongoing discussions of pending changes

• Understands the clinical drug development process, including clinical trial design, operations and results analysis

• Has excellent organizational, interpersonal and communication skills, and is able to develop and present varied and unique ideas

• Has exceptional attention to details and ability to analyze and assess data

• Has a good working knowledge of MS WORD, Excel and Power Point

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.