Alliance Manager Pharmacovigilance (PV) - Special Relationships Macclesfield United Kingdom,
location: macclesfield, cambridge, gothenburg or gaithersburg
at astrazeneca we work together across global boundaries to make an impact and find answers to challenges. we do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.
as an alliance manager pv – special relationships you’ll play an important role in negotiating optimal contracts for astrazeneca and medimmune whilst establishing excellent alliance relationships across a broad set of stakeholders internally and externally. this role will report to the Associate Director and is a position with opportunity for growth.
the mission of the alliance manager pv – special relationships at astrazeneca is to be responsible for alliance and Project Management support for the global Regulatory Affairs, Patient Safety, Quality Assurance (grapsqa) Licensing & acquisition (l&a) activities, portfolio and non-portfolio, for the special relationships team. your responsibility will include maintenance of the l&a portfolio and non-portfolio trackers, the production of the monthly l&a dashboards, the preparation of all meeting agendas, project manage plans to completion, ensure the l&a procedures, playbooks and guidance documents are fully updated and re-versioned. you’ll also support deviation/capa management process for l&a assessment activities
it’s a role that will contribute to the cross-functional grapsqa and enterprise l&a process, as supported by R&D. working with various stakeholder groups both within and outside of grapsqa, providing quality technical and content expertise to teams and reporting and summarizing to management.
main duties and responsibilities
you’ll lead and/or co-lead projects, develop and manage plans to achieve objectives and support milestone dp process for select opportunities.
you’ll apply technical and functional knowledge to plan and/or design projects that will enable meeting pv-related objectives associated with l&a objectives.
you’ll make decisions that require developing innovative options to resolve complex problems and you’ll operate independently in ambiguous situations.
you’ll provide Project Management expertise and skills to all l&a activities and deliverables and you’ll also map and evaluate the Due Diligence (dd), transition milestone dp, divestment and other applicable processes as well as providing recommendations, support the procedural revisions process and the creation of new procedural documents.
you’ll promote awareness and understanding of relevant pv-related Licensing processes and deliverables essential to astrazeneca’s pv and regulatory license to operate (lto) responsibilities thus ensuring effective collaboration and critical inputs with key internal and external interfaces.
you’ll ensure up-to-date view of internal and external environment, regulations, functional strategies and resources by regularly gathering information therefore ensuring optimal and compliant pv input to Business Development contracts.
you’ll develop innovative and original ideas to set tactical approaches and drive more effective operational plans for delivery of pv activities for l&a projects.
you’ll use your safety and regulatory knowledge to maintain and support the global inspection readiness Strategy as well as contribute to the overall management and oversight of the pv Quality System. you’ll also provide Training to grapsqa, partners and other functional groups.
at astrazeneca every one of our employees makes a difference to patient lives every day.
you may not feel you’re at the frontline of Research but your role in changing patients’ lives is critical. our mission is ambitious and it takes the skills of a collaborative team to really deliver on what science can do.
- a bachelor degree (preferably in science/Pharmacy/Nursing) with relevant experience in a large matrix organisation
- good knowledge of the Drug development process
- ability to interpret data to develop action plans
- ability to operate independently in ambiguous situations
- must have strong personal Leadership with demonstrated competency to interface with stakeholders at all levels
- experience in R&D across all product lifecycle phase requirements
- experience in process review, management and Change Management within global systems
- experience in contract or alliance management
- be a strong Leader and collaborator with the ability to problem-solve, be good in handling conflicts and have strong Negotiation skills
- lean sigma Training or certification
- knowledge of new and developing regulatory and pv expectations
should you be interested please apply by submitting your cv before 30th april 2018.
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.
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