Sciele Pharma, Inc.
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.
The Regulatory Affairs Advertising and Promotion Coordinator
will support the Associate Director of Advertising and Promotion of Regulatory Affairs with duties relating with 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
Proofreads promotional material, disease awareness materials, and Important Safety Information associated with assigned brands/therapeutic areas.
Knowledge of AMA writing style.
Captures consensus comments during live USRC meetings.
Ensures requested changes are incorporated appropriately.
Proofreads advertising promotional materials for Advisory Comment submission packages.
Verifies completeness of Form FDA-2253 submissions and OPDP advisory comment submissions.
Performs Quality Check of promotional layout of USPI materials.
Works with Regulatory Affairs Associate Director to determine effective regulatory pathways for a variety of issues.
Captures changes affecting standardized verbiage across brands.
Ensures that all annotations on promotional materials capturing requested changes are accurate, clear, concise, and complete.
Reviews/proofreads printer proofs; consolidate final changes on promotional materials.
Receives and distributes USRC review materials and assists the USRC Associate Director in preparing meeting agendas when necessary.
Assists 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.
MINIMUM JOB REQUIREMENTS
Bachelor's degree required.
1 plus years of regulatory affairs experience in Pharmaceutical Industry.
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
Please view Equal Employment Opportunity Posters provided by OFCCP here
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Sciele Pharma, Inc.
Website : http://www.sciele.com