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Sr. Associate, Regulatory Affairs (Labeling)

Schaumburg, IL

Posted: 05/06/2019 Employment Type: Contract To Hire Job Category: Clinical: Regulatory Job Number: 2235

Our client, a specialty oncology pharmaceutical company, is searching for a Sr. Associate, Regulatory Affairs (Labeling) for their Specialty Products Division. This position reports to the Vice President, Regulatory Affairs and incumbent is responsible for the support of label creation, development and review, including assistance with submission, deficiency and commercially available labeling updates based upon partner or FDA requests. Key activities include, but are not limited to, label version creation, critical proofreading review and edit changes.

Success in the role is measured on:
  • Timely and accurate completion of assigned tasks related to label development, proofreading, and copy review.
  • Minimal internal reworks with a continued focus on quality of labeling reviews.

  • 50% - Proofreading label copy at all stages of the product life cycle.
  • 50% - Creation of commercial, submission and deficiency labeling with a focus on ensuring that that all Regulatory, Quality and Manufacturing requirements are satisfied.
  • Bachelor’ s degree preferred, or equivalent cGMP related work experience. Science background degree preferred (Chemistry, microbiology/biology, pharmacy, premed, or nursing)
  • Experienced in the use of PC-Based word processing software, databases and spreadsheets (Microsoft Office Word and Excel preferred), and Adobe Acrobat. Experience with pharmaceutical labeling in any capacity is preferred. Experience in document comparison software a plus.
  • 3 to 5 or more years of direct pharmaceutical industry experience OR work experience in a cGMP and/or FDA regulated environment. Regulatory or Quality experience preferred.
  • Demonstrated proofreading ability
  • Passion for quality and an impeccable detail orientation
  • Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects
  • Solid interpersonal (verbal and written) communication skills at all levels.
  • Thrive in, and be able to work in, a fast paced entrepreneurial environment with broad responsibilities

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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