Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state of the art research capabilities that has provided innovative medicines essential to people's health for over 135 years. In the US, Shionogi
Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain and anti-infectives.
This Contract-Coordinator will support Regulatory Affairs Advertising and Promotion with a specific focus on the review and approval of advertising and promotional materials by the U.S. Review Committee (USRC) and related activities in addition to
other product regulatory activities.
DUTIES AND RESPONSIBILITIES
- Proofread promotional material, disease awareness materials, and Important Safety Information associated with assigned brands/therapeutic areas.
- Knowledge of AMA writing style.
- Capture consensus comments during live USRC meetings.
- Ensure requested changes are incorporated appropriately.
- Proofread advertising promotional materials for Advisory Comment submission packages.
- Verify completeness of Form FDA-2253 submissions and OPDP advisory comment submissions.
- Perform Quality Check of promotional layout of USPI materials.
- Work with Regulatory Affairs Associate Director to determine effective regulatory pathways for a variety of issues.
- Capture changes affecting standardized verbiage across brands.
- Ensure that all annotations on promotional materials capturing requested changes are accurate, clear, concise, and complete.
- Review/proofread printer proofs; consolidate final changes on promotional materials.
- Receive and distribute USRC review materials and assists the USRC Associate Director in preparing meeting agendas when necessary.
- Assist in managing meeting time constraints; minimize side discussions.
- Help when required in proofreading Labeling documents such as Bottle Labels, Sample Cartons, Blisters, and Product Labels.
- Bachelor degree preferred.
- 1 plus year of similar experience in Regulatory Affairs; must include capturing consensus comments during live USRC meetings.
- Strong attention to detail.
- Ability to manage multiple projects simultaneously.
- Strong organization skills with the ability to prioritize multiple activities/projects and work in a fast-paced environment.
- Excellent oral and written communication skills.
- Knowledge of Adobe Acrobat commenting tools.
- Must have experience working with Adobe Professional, Excel, Word, PowerPoint, Adobe Acrobat and, Veeva PromoMats experience a plus.
- Highly motivated self-starter with strong project management skills and ability to perform/prioritize tasks in a fast-paced environment with limited supervision is a plus.
- Flexible; ability to adapt to changing priorities is preferred.
- Must have the ability and willingness to take initiative.
- Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.
To be considered for this position, you must apply online at: https://www.shionogi.com/careers/careers.html
-- and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.
- We are an Equal Opportunity Employer.
- Please view Equal Employment Opportunity Posters provided by OFCCP here.