Associate Director, Promotional Regulatory Affairs
Category: Research & Development | Country: UK | City: Oxford | Type: Regular, Full Time | Job ID: 4420
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.
The Associate Director, Promotional Regulatory Affairs, EU/ROW will be a member of the Jazz Global Regulatory Affairs Department and serves as an internal expert on European (EFPIA) and International (ex-US) regulations governing the promotion of prescription pharmaceutical products. The role will provide critical support to this key business process; providing strategic input and regulatory review for commercial activities for the EU/ROW markets; interacting with Health Authorities and assisting with managing responses to inquiries if required. The Associate Director reports to the Senior Director, Promotional Regulatory Affairs) and with their oversight 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 as well as medical materials that are compliant with regulations, relevant codes of conduct and company policies, while supporting achievement of business objectives. 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 supporting EU/ROW advertising and promotion activities, with oversight from the Senior Director for Promotional Regulatory Affairs, and for 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.
- Responsible for maintaining a process and collaborating on establishing standards to ensure that promotion for products 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 (e.g. brand team, brand planning, etc.). Provide regulatory strategy, guidance, and consultation on marketing strategies and promotion objectives and tactics as well as medical education tactics.
- Lead 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
- Support to EU/RoW Medical Affairs activities by providing regulatory review of scientific publications and scientific oral and poster presentations as well as other medical programs and tactics.
- 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 collaborativley to find solutions to promotional material review challenges and implement process enhancements as needed.
- Bachelor degree minimum, Masters, or other advanced degree in a scientific discipline preferred
- Track record of increasingly responsible experience in the pharmaceutical industry, including direct experience in advertising and promotional material review
- At least 3 to 5 years of experience and knowledge in the Advertising & Promotion field, including excellent 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 Employer.