Regulatory Advertising/Promotion Sr. Manager
Title: Regulatory Advertising/Promotion Sr. Manager
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. The name is the blend of the words individual and endeavor, and the tagline Focus on you makes the companys commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction a chronic relapsing disease.
Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction including opiate overdose, alcohol use disorders and cocaine intoxication - as well as related mental health disorders such as schizophrenia.
The Regulatory Advertising/Promotion Sr. Manager is a skilled regulatory manager with strong understanding of the FDA regulations associated with Ad/Promo 21 CFR Part 202 (Prescription Drug Advertising) and possesses excellent review and editing ability. The have the managerial skills regarding the production of instructions for the safe and effective use of drug products for human consumption, understand prescription drug labeling and have an understanding of DTC ads, Reminder ads, Testimonials, Internet advertisements, Press Releases which are related to commercial communication about RBP drug products. The manager ensures the advertisement and promotional pieces and in line with product labeling and are of quality and compliance with FDA regulations throughout the drug product label life cycle. They should also have the ability to relate the prescribing information into Advertising and Promotional material and be willing to work within a commercial environment with other functional contributors within the Promotional Review Committee.
The responsibilities of this job include, but are not limited to, the following:
Maintain knowledge and understanding of FDA regulations and guidelines regarding drug product labeling (especially 21 CFR, Parts 201 and 202 and the associated FDA guidelines. Have familiarity with 21 CFR 210 and 211 requirements.
Research and evaluate Advertisement and Promotional/labeling precedents for marketed drug products to help with guidance.
Monitor FDA regulations and guidelines for periodic changes, and assess the impact of regulatory changes on Reckitt Benckisers currently approved or planned product Ad/Promo pieces and relation to Rx product labeling.
Assess the impact of proposed label changes for a particular product on all other associated or related RBP product against its impact on Advertisement and Promotional materials.
Represent the RBP Regulatory Affairs department on Promotional Review Committee with responsibility for generating timely & complete deliverables on promotional pieces.
Conduct reviews utilizing a validated electronic system
Understanding of Risk Evaluation and Mitigation Strategies (REMS).
Assist in the regulatory review and copy clearance of marketing pieces and promotional labeling that the Reckitt Benckiser Pharmaceuticals Inc. markets develop from the approved product labeling.
Provide training to process contributors.
May have oversight of Ad/Promo consultant.
Assist in other regulatory activities may be required.
Bachelors degree in a bio-medical science or related field
5-10 years experience in the pharmaceutical industry focused on Ad/Promo.
A comprehensive and current understanding of prescription drug products, medical writing, FDA regulations and guidance on Ad/Promo a must.
Advertisement and Promotional Material experience with a high level of understanding of compliance with US regulations and guidelines related to all types of commercial communications (desk drops, social media, magazine ads, TV, radio, website, managed care pieces, promotional and non-promotional, disease awareness pieces) convention activities, dissemination of scientific literature/reprints etc.
A minimum of 3-5 years of labeling quality and compliance with US regulations throughout the drug product label life cycle having been devoted to the development of final product labeling in the regulated pharmaceutical drug products with correlation to Advertisement and promotional pieces.
Oversight of OPDP 2253 submissions and component coding.
Be able to supervise external promotional review resources if needed.
Ability to manage high volume of promotional reviews and work flow for precise compliance with appropriate drug product industry standards and relevant RBP Promotional Review Committee SOPs
In addition to the minimum qualifications, the employee will demonstrate:
Excellent verbal and written communication and organizational skills
Ability to review material within the confines and structure of an organized database system
Ability to demonstrated strong team work and work as an effective team member
Excellent management and project coordinating skills
Indiviors guiding principles are the foundation for each employees success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
EQUAL EMPLOYMENT OPPORTUNITY
Website : http://www.indivior.com/
Indivior began with the goal of addressing the lack of treatment for the worldwide problem of addiction. In 1994, RB established the Buprenorphine Business Group, to which Indivior can trace its history of over 20 years. The buprenorphine Business Group focused on developing buprenorphine for the treatment of opioid dependence. Even though it was an area of business that was unproven, we believed we could make a measurable difference in the lives of patients all over the world. Through a grassroots effort, we’ve partnered with and educated governments, policy makers, payers, and heathcare professionals about diseases of addiction and the value of alternative treatment options (including office-based treatment). We’ve also worked diligently and strategically to identify and address the unmet treatment needs of patients. By creating a marketplace environment of increased acceptance, we have provided an estimated 5 million patients effective treatment options with SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII), SUBOXONE® (buprenorphine and naloxone) Sublingual Tablet (CIII), and SUBUTEX® (buprenorphine) Sublingual Tablet (CIII) in the US alone, always keeping our focus on the individual.