Some opportunities happen only once in a lifetime – like a job where you have the chanceto change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
The Manager, Global Advertising and Promotional Compliance forms part of a cross functional team responsible for the review and approval of promotional and non-promotional materials in the International region (markets outside of US and Japan).
Review and approval of materials, typically involves Medical, Legal and Regulatory functions, the Manager will act as the regulatory reviewer to ensure specified materials and activities linked to promotion meet external regulations, industry code of practice standards (EFPIA/IFPMA) and Company policies. The regulatory reviewer will also be the primary liaison for the final signatories of materials at company affiliates to promote best practices and provide support on regulatory issues concerning promotional materials.
The Manager will engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review, and approval of promotional materials in the International region.
You will be responsible for:
- Act as primary advertising and promotional compliance contact within assigned therapy area(s), for review and approval of promotional and non-promotional materials / activities including disease awareness, medical materials etc.
- In close collaboration with Medical Affairs, participate in concept review meetings to provide regulatory guidance to Project Owners responsible for the distribution of materials
- Ensure promotional and non-promotional materials are in compliance with global standards and external regulations pertaining to prescription drug advertising and promotion, as applicable
- As needed, provide training support within Alexion on requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
- In collaboration with their Senior Manager in the Global Advertising and Promotional Compliance group, provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products
- In collaboration with regulatory affairs, ensure stakeholder awareness of proposed and newly approved labeling changes
- Provide guidance to Project Owners to ensure appropriate implementation of labeling changes to promotional materials in a timely manner
- In collaboration with their Senior Manager in the Global Advertising and Promotional Compliance group, participate in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices to establish standards and consistency across International region
You will need to have:
- Bachelor’s degree in science or pharmacy
- 2 -5 years of relevant experience within regulatory, medical affairs or healthcare compliance in the EU region
- Experience with applicable standards for advertising and promotion including EFPIA / IFPMA
- Proven track record practicing sound judgment as it relates to risk assessment
- Knowledgeable on industry compliance requirements and non-compliance examples and trends
- Demonstrated ability to influence others and foster team collaboration
- Strong interpersonal, communication and leadership skills.
- Proven ability to prioritize and meet critical business timelines
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- Bachelor’s in Pharmacy, PharmD or master’s degree preferred
- Good knowledge of ABPI Code of Practice
- Direct experience communicating and negotiating directly with regulatory agencies is helpful
Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Furtherinformation about Alexion can be .
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, clickhere.