Job Summary

Independently reviews, revises, and approves content and context required of promotional labeling materials for prescription drug and medical device products. Must be effective in managing work and resolving conflicts. Must demonstrate a high level of understanding of regulations related to promotion compliance. May be assigned additional responsibilities as deemed necessary.

Job Description

Independently reviews, revises, and approves content and context required of promotional labeling materials for prescription drug and medical device products. Must be effective in managing work and resolving conflicts. Must demonstrate a high level of understanding of regulations related to promotion compliance. May be assigned additional responsibilities as deemed necessary.

Job Responsibilities

Directs or assists junior staff member(s) or independently reviews, revises and approves content and context required of promotional labeling materials for prescription drug and medical device products. Ensures that promotional labeling and training material meet regulatory and company requirements. Provides alternative suggestions to allow for consistent messaging. Serves as the primary contact/liaison with the FDA Office of Prescription Drug Promotion (OPDP), responsible for establishing working relationship and managing communication with OPDP reviewers for advertising and promotion matters, including advisory comments. Provides training to OAPI/OPDC employees on regulations for labeling and promotion compliance as appropriate. Monitors and informs others of changes in US labeling and promotional regulations as well as corporate policies and procedures, as appropriate. Recommends improvements to labeling policies, processes, quality, and system tools. Manages contracts for contractors and consultants. Contributes to SOPs for review and submission and of advertising and promotional materials. Implements strategies to apply labeling updates that impact promotional materials. Collaborates 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/ Required

Knowledge/ Experience and Skills:

Required:

• Solid understanding of US regulatory requirements
• Broad knowledge of clinical medicine and clinical pharmacology
• Excellent understanding of medical concepts and terminology
• Solid understanding of the structure and function of the product labeling
• Fundamental understanding of the pharmaceutical industry drug development process

Preferred:

• Able to work across multifunctional groups
• Strong written and oral communication skills
• Good 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 teams

Educational Qualifications

Education and Experience

• Bachelor's Degree required (life sciences disciplines strongly preferred)
• 4+ years of experience in promotional compliance and product labeling in the pharmaceutical industry
• Advanced Degree in related field is preferred

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. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Competencies

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - 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. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. 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 will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc., and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. 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. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.