Temp - Clinical Compliance Associate

Location
Tarrytown, New York, US
Posted
Sep 23, 2018
Ref
14021BR
Required Education
Bachelors Degree
Position Type
Contract
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:

As a member of the Clinical Compliance team, this position provides administrative and project management support. This position will provide support for the suspected serious noncompliance process.

Duties:

• Assist in the management of files and associated data supporting the Suspected Serious Noncompliance, Audit Responses and Investigator Usability processes overseen by the Clinical Compliance function

• Assist where needed with scheduling alert meetings for Suspected Serious-Non Compliance cases

• Provides support in the investigation of Suspected Serious Non-Compliance as needed by tracking timelines to assure that projects are completed on time

• Supports closure of CAPA action items, when needed

• Supports Clinical Review Committee process

• Disseminates essential information and status updates to management on assigned projects

Requirements:

• Excellent organizational skills

• Working knowledge of the clinical drug development process

• Demonstrated analytical skills with attention to detail

• Solid computer skills requirement of MS applications including (but

• not limited to) MS Project, Word, Excel, Sharepoint and Outlook

• Comfortable interacting with Sr. Management.
Bachelor's degree with at least one year experience in the pharmaceutical industry
Associates degree with 3-4 years' experience in lieu of Bachelor's degree.
High School diploma with 6-8 years' experience in lieu of Associate's degree.

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.