Job title: GRA Manager, Global Advertising and Promotional Compliance
Company: Alexion Pharmaceuticals
Job description: Some opportunities happen only once in a lifetime – like a job where you have the chance to 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.
GRA Manager, Global Advertising and Promotional Compliance
This is what you will do:
The Manager, Global Advertising and Promotional Compliance serves as the Regulatory Affairs (RA) representative on product promotion review teams. The Manager has responsibility for reviewing and approving the regulatory content of international materials created for product promotion, disease awareness and public affairs communications in EU and markets outside of US and Japan. 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. The Manager also acts as the primary liaison with local regulatory leads, especially in the EU and Canada, to support on regulatory issues concerning promotional materials.
You will be responsible for:
- Reviews global promotional, disease awareness, public affairs and medical materials, attends promotional review meetings and provides regulatory guidance to the cross-functional team responsible for ensuring material compliance with global compliance standards regulations pertaining to prescription drug advertising and promotion, as applicable
- Serves as primary contact for the review of promotional materials in the International region.
- As needed, provides training support within Alexion on regulatory 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, will provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products
- Ensures stakeholder awareness of proposed and newly approved labeling changes
- Provide guidance to (G)MLR (global medical legal regulatory) to ensure appropriate implementation and reflected in assigned product SmPC and promotional materials in a timely manner
- In collaboration with their Senior Manager in the Global Advertising and Promotional Compliance group and (G)MLR Coordinator, 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 company products
You will need to have:
- Bachelor’s degree in science or pharmacy
- 2 -5 years of relevant experience in the EU region
- Direct experience communicating and negotiating directly with regulatory agencies is helpful
- Experience with global standards for advertising and promotion compliance
- 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
Alexion is 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. Further information about Alexion can be found at: .
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 lack thereof, sex, sexual orientation, 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 an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. 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, click .
Location: Canada – Boston, MA
Job date: Tue, 17 May 2022 22:43:08 GMT
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