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Manager, Clinical Transparency

Employer
Regeneron Pharmaceuticals, Inc.
Location
Basking Ridge, NJ, United States
Start date
May 23, 2021

View more

Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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