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Lead, Safety Agreements & Contracts

Posted 25 Mar 2024
Work experience
3 to 5 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
English (Fluent)

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At AstraZeneca, we’re not afraid to do things differently. We’re resetting expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, ground-breaking and ground-breaking methods and bringing unexpected teams together.

The new R&D Oncology (ORD) organisation brings together early and late oncology teams, from discovery through to late-stage development, with oncology specific Regulatory and Biometrics groups. The organisation also brings together the new Chief Medical Officer (CMO), Precision Medicine and the R&D organisations in China and Japan which will partner both ORD and R&D BioPharmaceuticals (BPRD).

Within the CMO department, we are looking for a Lead, Safety Agreement and Contracts, Patient Safety Centre of Excellence, based in Gaithersburg, US, Macclesfield, UK, or Cambridge, UK. Reporting intotheSection Director License Agreement & Contracts, this is a newly created strategic leadership role.

Major Responsibilities and Accountabilities:

In this role, you will own long term stewardship of the Pharmacovigilance Agreements business area, ensuring negotiation of optimal, compliant PVAs for AZ whilst establishing good teamwork and maintaining positive working relationships with third party partners.

You will provide advice, mentorship and interpretation of matters relating to PVAs to demonstrate the value of Patient Safety as a key partner to AZ internal & external business

You are expected to collaborate with ORD, BPRD, Business Operations and AZ Legal providing advice and support for commercial agreements ensuring that optimal and compliant PV obligations are included as required.

You will Line Manage the aligned Safety Agreement principals, including mentoring and development of the team.

Additional responsibilities:

  • Have oversight and provide mentorship to the Safety Agreements principals in their authoring and life cycle mnagement of PVAs.
  • Manage resources and workload across the internal and external (outsourced) team.
  • Accountable for the oversight, lifecycle management, planning and development of the PVA area, ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies.
  • Partner with relevant counterparts to optimize and deliver effective PVAs.
  • Accountable to demonstrate and contributes to a culture of “ownership” and efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/stakeholder engagement.
  • Engage and influence internal and external key partners to drive the strategy, development and continuous improvement of processes, technology and services within the PVA area they lead.
  • Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the area. Work with Line Managers and Leadership to prioritise the needs and resources required to deliver these requirements, and provide feedback and clear rationale for any areas that will not be addressed.
  • Accountable for managing the relationships with partners.
  • Partner with ISSA counterparts to ensure an integrated and pragmatic approach to processes and systems.
  • Work with the Section Director, Inspection Readiness Business Performance to monitor the overall performance of the processes and technology within the nominated area. Track and monitor agreed key performance indicators, lead the delivery of Corrective and Preventive Actions to time and quality, and act on data or trends identified through the Quality & Risk Management process
  • Establish a global mind-set to systematically gather, consolidate & communicate regulatory authority and industry intelligence for the continuous improvement of activities required to ensure license to operate and regulatory compliance
  • Project manage projects to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input and guidance in cross functional teams.

What do we need from you?

Essential:

  • University degree or equivalent qualification in relevant scientific discipline
  • Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals
  • Experience from authoring, negotiating and maintenance of agreements and contracts with external party
  • Experience from tracking and monitoring business performance through SLAs and targets
  • Experience of leadership of team, either as line manager or project leader
  • Experience in outsourcing and partnership with external vendors
  • Ability to influence multiple business partners
  • Demonstrated excellent skills in: written and verbal communication
  • Able to represent AstraZeneca externally where required

Desireable:

  • 3-5 years Alliance management, and 5-7 years Global Regulatory, Patient Safety and/or Clinical Development experience
  • Deep understanding of Regulatory Environment (e.g. FDA, MHRA, EMEA, other key markets/areas)
  • Change management experience
  • Experience with contracts including licensing agreements, safety agreements, etc..
  • Excellent knowledge of inspections/inspection activities as it relates to licensing agreements

Key capabilities:

  • Understanding of governance processes
  • Process improvement (eg Lean methodology)
  • Collaboration/co-ordination
  • Financial awareness
  • Ability to influence without authority
  • Open to multiple perspectives
  • Balanced perspective
  • Solution focused
  • Experience with inspection activities

Next Steps – Apply today! This job posting expires on June 7th.

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

AstraZeneca is a global, science-led biopharmaceutical company that spans the discovery, development, manufacturing, distribution and worldwide commercialisation of primary care and speciality care medicines.

Pharmaceutical
Cambridge
53,000 employees