Mediabistro is hiring: Associate Director, Promotion Compliance Strategic Adviso

Implements strategies to apply labeling updates that impact promotional materialsCollaborates with all review team members during development of promotional materials or other types of product communications to provide comprehensive regulatory compliance guidance.Ensures product promotional materials are submitted to OPDP on Form FDA 2253 in a timely manner as per regulations, and that materials are archived as per company policy.Qualifications / RequiredKnowledge / Experience and Skills :Required :Solid understanding of US regulatory requirementsBroad knowledge of clinical medicine and clinical pharmacologyExcellent understanding of medical concepts and terminologySolid understanding of the structure and function of the product labelingFundamental understanding of the pharmaceutical industry drug development processPreferred :Able to work across multifunctional groupsStrong written and oral communication skillsGood computer skills including experience with MS Office : Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat.Capable of dealing with ambiguity and comfortable working with multifunctional teamsEducational QualificationsEducation and ExperienceBachelor's Degree required (life sciences disciplines strongly preferred)4+ years of experience in promotional compliance and product labeling in the pharmaceutical industryAdvanced Degree in related field is preferredDisclaimerThis job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. Influence at all levels to achieve the best results for Otsuka.Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.Empowered Development -Play an active role in professional development as a business imperative.Come discover more about Otsuka and our benefit offerings; https : / / www.otsuka-us.com / careers-join-otsuka .Disclaimer :This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.Please understand, Otsuka willneverask for financial information of any kind or for payment of money during the job application process. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at : https : / / www.ic3.gov , or your local authorities.Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.