Sr. Manager-Medical Compliance
The Senior Medical Compliance Manager is accountable for leading medical
nominated signatory governance of the assigned therapeutic areas for AstraZeneca
China, guiding marketing and medical activities to be undertaken in a compliant and
ethical manner, optimizing medical compliance related awarness and behavior of
assigned internal customer (group), leading quality assurance and/or quality control
of implementation of medical compliance excellence in assigned internal customer
(group), and acting as key contributor supporting marketing company level
compliance governance programs
- Act as the nominated signatory of the assigned therapeutic area of AstraZeneca China.
- Review and approval of materials and activities, including, but not limited to,
- product-related promotional materials, meeting invitations, presentations, patient and medical educational materials, advisory board meetings, non-promotional scientific meetings, sponsorships, sales related activities and sales training materials of the assigned therapeutic areas produced by brand team and/or medical team in accordance with local legislation, Codes of Conduct/Practice and AstraZeneca internal standards, ensuring consistency with product license.
- Ensure compliance with meetings/materials review and approval process.
- Ensure efficient promotional/non-promotional review and appropriate recording and logging of all activities on internal databases in line with the approval process.
- Ensure brand claims are scientifically balanced with respect to all available evidence and that they reflect good medical practice, ethical issues and tone, combined with intelligent risk management and solution identification.
- Proactive, early stage guidance/influencing of brand teams in development of promotional materials and activities.
- Assist brand teams to defend strategic brand claims against complaints by competitor companies and challenging unacceptable practices of competitor companies.
Job Role Description –Senior Manager, Medical Compliance
- Maintain a customer-focused perspective on promotional regulatory matters and lead AstraZeneca China adaptation to a changing promotional regulatory environment from a medical perspective.
- Education of assigned therapeutic area of AstraZeneca China in provisions of the industry code while supporting Corporate Governance in education of the
- Global Policies related to the nominated signatory role.
- Education of assigned therapeutic area of AstraZeneca in required standards for promotional/non-promotional materials and activities as required.
- Ability to challenge members of brand team when proposed promotional claims or activities expose AstraZeneca to unacceptable commercial or ethical risk, and proposes alternative ways of proceeding which minimise risk and optimise commercial outcomes.
- Act as a quality control for all scientific material produced by the China Brand
- Teams, checking accuracy of references, sources, statements and data prior to distribution internally across the commercial organisation, or externally.
- Act as policy expert of both AstraZeneca compliance policies and compliance related standards specified by China local laws and regulations.
- As the quality assurance and/or quality control responsible person for assigned internal customer (group), preparing/reviewing annual quality assurance/quality control plan, leading relevant compliance education, communication, and optimization programs.
Skills and Job requirements
- Advanced medical/pharmacology or bioscience qualification with 5+ years’ experience of the pharmaceutical industry
- Detailed scientific understanding of the allocated therapeutic Area.
- Sound knowledge of international and RDPAC medical compliance legislation, codes of practice and their practical application.
- Knowledge and experience of corporate governance are desirable.
- High ethical standards. An understanding of ethical decision making processes and an ability to discuss ethical and regulatory issues with credibility and authority.
- Strong independence and analytical skills
- Excellent communication and presentation skills.
- Excellent interpersonal, influencing and networking skills - the ability to operate as part of a team, to build trust and respect throughout the business unit, to interact effectively across different functions, seniority levels and cultures within the Company and externally
- Fluency in English, written and spoken.
- Fluency in Mandarin, written and spoken
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.