Jazz Pharmaceuticals

Associate Director, Promotional Regulatory Affairs EU/ROW

UK-Oxford
1 month ago(12/19/2017 4:55 AM)
ID
2017-3338
# of Openings
1
Category
Research & Development

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

Position Profile

Associate Director, Promotional Regulatory Affairs, EU/ROW serves as an internal expert on European (EFPIA) and International (ex-US) regulations governing the promotion of prescription pharmaceutical products.  The associate director will provide regulatory oversight/ leadership to this key business process; providing strategic direction and regulatory review for commercial activities for the EU/ROW markets; interacting with Health Authorities and assisting with managing responses to inquiries if required. In this position, the Associate Director will work collaboratively with the EU/ROW Medical, Legal, Compliance and Commercial organisations and apply expertise and organisational influence to ensure development of  promotional programs and tactics that are compliant with regulations, relevant codes of conduct and company policies, while supporting achievement of business objectives.  Reporting to the Head of EU/RoW Promotional Regulatory Affairs and Labeling, this position must be capable of representing the commercial regulatory perspective and applying expertise and organizational influence with cross functional teams.

The role is responsible for operating an EU/ROW advertising and promotion Center of Expertise, determining work processes and resource needs, and must be knowledgeable in applying the IFPMA, ABPI, EFPIA codes of conduct and build a network to ensure adherence to local country regulations and codes of conduct for markets where our products are marketed.

Essential Functions

  • Accountable for maintaining a process and establishing standards to ensure that promotion for products in markets supported comply with company policies and SOPs, while maintaining consistency across markets in the core promotional efficacy claims and risk information.  
  • Support EU/ROW marketing and medical teams by participating in strategy discussions and extended team meetings.  Provide regulatory strategy, guidance, and consultation on marketing strategies and promotion objectives and tactics as well as medical education tactics. Lead and own the promotional material review process and make decisions regarding concepts and draft promotional materials to satisfy the letter and spirit of applicable EFPIA/International promotional regulations, corporate standards and policies and business objectives. Taking responsibility for the review and approval of International Promotional materials from a regulatory perspective.
  • Support regional and local employees by developing a network of regulatory and medical contacts, acting as consultant in regulatory and compliance matters, supporting local employees in promotional complaints, and determining the training needs for International stakeholders.
  • Support development of and adherence to company policies, processes and standards for promotional compliance and participate in the revision, update and approval of EU/ROW SOPs, policies and associated materials, including the development, integration and update of local processes and standards for promotional material review.
  • Provide input on promotional implications of proposed clinical study designs, draft publications, commercial campains and compliance issues
  • Maintain a deep and current awareness of evolving regulations, codes of practice and policy issues affecting the pharmaceutical/biologics industry in relation to advertising and promotion. Interpret and communicate health authority perspectives to relevant stakeholders and recommend policy and/or procress changes as needed.
  • Work to find solutions to promotional material review challenges and implement process enhancements as needed.

Minimum Requirements

  • Bachelor degree minimum, Masters, or other advanced degree in a scientific discipline preferred
  • Minimum of 8 years of increasingly responsible experience in the pharmaceutical industry, including at least 5 years of direct experience in advertising and promotional material review
  • Extensive experience and knowledge in the Advertising & Promotion field, including superior working knowledge of IFPMA, EFPIA, and ABPI related advertising codes 
  • Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire company.
  • Outstanding verbal and written communication skills.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Jazz Pharmaceuticals is an Equal Opportunity Employer.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!