Temp - Clinical Procedural Document Writer

Regeneron Pharmaceuticals
Oct 18, 2016
Oct 19, 2016
Employer Type
Direct Employer
Employment Type
Full Time
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.


Within the team of Clinical Compliance Process & Procedures, this position will write, edit and coordinate content for the development and maintenance of Clinical Development and Regulatory Affairs (CDRA) Procedural Documents (Standard Operating Procedures (SOPs), Work Instructions, Guidance Documents, Forms/Templates and Job Aids). This role requires that the candidate work closely with Senior Managers in the Clinical Compliance Process & Procedures group and Functional Subject Matter Experts at all levels to support/ensure the successful launch of assigned procedures.


• Revise current controlled documents based on process changes and new templates ensuring consistency across processes and between associated documents

• Act as subject matter expert on writing style and formatting enforcing template standards when necessary

• Develop and revise process maps, as needed, based on controlled processes developed by Subject Matter Experts

• Perform quality checks on document format and style to ensure consistency across processes and between associated documents

• Work with Director of Clinical Compliance, Process & Procedures and team on the development of controlled document transition plans, as needed, to assure successful implementation of new and revised processes.

• Provide editing of draft before feedback review cycles and final documents

• May assist Clinical Compliance Process & Procedures Senior Managers in new or revised process improvements or other activities, as needed


• Bachelor's Degree

• 5 years in a Pharmaceutical/Biotech company within Clinical Development; (at least 3 years in a GCP environment)

• Understanding of Clinical Development processes primarily related to Clinical Trials, Data Management, Biostatistics/Statistical Programming, Regulatory Affairs and PV Risk Management

• Demonstrated proficiency in writing quality SOPs and supporting documents in a GCP/ICH environment

• Strong technical skills in Microsoft Word (formatting, style, etc.). Experience in Microsoft Visio is a plus.

• Excellent written and verbal communication skills and ability to work with people in all levels of the organization

• Ability to manage multiple priorities with demonstrated proficiency in project management

• Experience with process mapping

• Experience with PleaseReview and QUMAS Document Management System or equivalent is a plus

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. 96447fefe95abd3313dd9e28b