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Regulatory Advertising and Promotion Policy Associate Director

Company: GlaxoSmithKline
Location: Waltham
Posted on: September 12, 2020

Job Description:

Regulatory Advertising and Promotion Policy Associate Director Philadelphia, Pennsylvania; Waltham, Massachusetts; Research Triangle Park, North Carolina

Regulatory

252043

Are you interested in providing sound regulatory advice that is consistent with applicable FDA regulations and GSK policies for advertising and promotion of prescription drug products and biologics, while competitively positioning assigned products? If so, the Regulatory Advertising & Promotion Policy role may be ideal for you to explore.

As a Regulatory Advertising & Promotion Policy Associate Director, you will have the opportunity to:

Competitively position promotional materials that comply with applicable FDA and corporate regulations, policies and guidance

Serve as internal expert on FDA regulations governing the promotion of assigned products.

Act as a credible, influential, respected spokesperson during interactions with the Office of Prescription Drug Promotion (OPDP) reviewers for assigned products

Establish and nurture a productive, transparent relationship with OPDP to achieve successful and timely review of advisory submissions and effective resolution of regulatory actions.

Manage interaction with OPDP including response to regulatory inquiries or enforcement actions, preparation of complete, accurate, high quality submissions for advisory comments, and discussion with OPDP staff on requested changes.

Appropriate, proactive communications with OPDP reviewers that help ensure expedient and efficient review of regulatory submissions

Provide leadership on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate

Ensure all submissions to OPDP are complete, accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review.

Monitor OPDP activities and actions, assesses impact and communicates information to stakeholders.

Advise on the development of US labeling to ensure support for anticipated promotional messages and claims.

Influential member of multiple cross-functional US Pharma and R&D teams with junior and some senior membership

Analyze whether non-clinical promotional claims are supported

Ensure application of key learnings across assigned brands

Recommend appropriate actions for proposed advertising and promotion with established precedent

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :

Provides operational leadership to Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of in advertising and promotion for the US market (for minor company assets) in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and company policy

Effective communications with reviewers within OPDP that expedite resolution of issues relating to assigned products

Understanding of labeling for assigned GSK and competitor products

Ensure that changes in US prescribing information are reflected in current promotion and advertising

Participate in company working groups on advertising and promotion standards and guidelines

Maintain a quality system to support advertising and promotion regulatory requirements

Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:

Undergraduate degree in a biological or health care scientific discipline

2-5 years of experience in pharmaceutical/biologics regulatory, or scientific disciplines

1-2 years in the review of prescription drug adverting and promotion.

Preferred Qualifications: If you have the following characteristics it would be a plus:

Be able to demonstrate strategic and analytical thinking

Demonstrated success in constructive contributions to multidiscipline matrix teams.

Demonstrated ability to facilitate appropriate team decisions

Advanced degree in biological or health care scientific discipline

5 -10 years of experience in pharmaceutical/biologics regulatory, or scientific disciplines

2-5 years in the review of prescription drug adverting and promotion for compliance with applicable FDA laws, regulations and guidance documents

Demonstrable history of successful interactions with FDA reviewers at OPDP.

Understanding of product development process, including clinical trial design, and labeling development process

Proven ability to multi task and excel in cross functional settings and to manage multiple projects in a fast-paced environment

Why GSK? Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.

Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

Continuously looking for opportunities to learn, build skills and share learning.

Sustaining energy and well-being.

Building strong relationships and collaboration, honest and open conversations.

Budgeting and cost-consciousness.

*LI-GSK

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

Regulatory Advertising and Promotion Policy Associate Director Full-Time, Philadelphia, Pennsylvania, United States Regulatory Advertising and Promotion Policy Associate Director Full-Time, Philadelphia, Pennsylvania, United States Start a career with purpose GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer.

Annual bonus based on company performance

Long term incentives and pension plan

Learning and career development

Access to healthcare & wellbeing programmes

Keywords: GlaxoSmithKline, Waltham , Regulatory Advertising and Promotion Policy Associate Director, Other , Waltham, Massachusetts

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