Temp - Senior Clinical Documentation Associate

Regeneron

Experience
Workhours
Company Type

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:
Collaborates with the clinical study team to set up, manage and oversee the study trial master file (TMF). Creates and maintains the TMF plan and the study specific inventory list. Advise the study team about the status of the TMF (completeness, quality and timeliness) and ensures the completion and resolution of the periodic quality reviews. Responsible for locking the TMF at the end of the study following approval by all functional areas.



Responsibilities:
Collaborates with the clinical study team to set up, manage and oversee the study trial master file (TMF). Creates and maintains the TMF plan and the study specific inventory list. Advise the study team about the status of the TMF (completeness, quality and timeliness) and ensures the completion and resolution of the periodic quality reviews. Responsible for locking the TMF at the end of the study following approval by all functional areas.




Requirements:
Bachelor’s degree or equivalent and 3 years of experience
• A demonstrated, deep understanding of the TMF Reference model and processing of documentation into the eTMF system.
• Ability to create the TMF plan and ensure compliance by the study team
• Demonstrated ability to prioritize and manage multiple projects simultaneously
• Demonstrated ability to work effectively with many different types of personalities at all levels of the organization
• Excellent interpersonal, collaboration and stakeholder management skills
• Excellent communication skills (written/verbal)
• Highly self-motivated, flexible, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure
• Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking
• Highly proactive, flexible, curious and resilient
• Proficient in Microsoft Applications; Word, Excel, Project, and PowerPoint
• Ability to travel (<10%)

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.

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Confirmed 17 hours ago. Posted 30+ days ago.

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