Manager, Clinical Transparency

Location
Basking Ridge, NJ, United States
Posted
May 23, 2021
Ref
24216BR
Required Education
Bachelors Degree
Position Type
Full time
Manager, Clinical Transparency will be responsible for owning the redaction and anonymization of clinical trial documents required for public disclosure. This role will partner with internal and external stakeholders for the planning, initiation, and delivery of redacted/anonymized documents required for Regulatory Authority Transparency Submissions (e.g., EMA Policy 0070, Health Canada PRCI), manuscript publications, clinical trial registries, and data sharing. We expect you 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 the following:
  • Leads clinical trial document redaction/anonymization projects against planned timelines, in accordance with REGN SOPs and regulatory requirements, and advances issues, as necessary
  • Monitors and tracks document requests and develops timelines for redaction
  • Interacts cross-functionally to lead the review of clinical trial documents to identify confidential commercial information and personal data
  • Collaborates with Regulatory Operations to ensure appropriate publishing of redacted documents in RDMS
  • Interacts with external vendor(s) to ensure documents are anonymized/redacted according to established internal guidelines and required timeframes
  • Ensures consistency and quality of publicly disclosed documents across the portfolio
  • Maintains up-to-date knowledge of global data transparency laws, regulations, and requirements
  • Supports process improvement and the development of new procedures to adapt to the evolving data transparency landscape
  • Collects and reviews individual and team metrics
  • Supports internal inspection activities and contributes to CAPAs, as needed
This role might be for you if:
  • Excellent written and oral communication skills
  • Attention to detail and the ability to deliver on assigned activities
  • Proactive and self-disciplined, ability to manage time and prioritize work as required
  • Understands the clinical drug development process, including clinical trial design, operations, and results analysis
  • Technical proficiency in MS Office applications, Adobe, and Regulatory Document Management systems
  • Knowledge of disclosure and transparency requirements and regulations, as well as ICH/GCP and regulatory guidelines/directives
  • 6+ years in the biotechnology/pharmaceutical industry; experience in transparency and disclosure, or operations preferred

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.