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Senior Manager of Medical Writing - Oxford, Oxfordshire, United Kingdom - Jazz Pharmaceuticals
Description
Jazz Pharmaceuticals plc (NASDAQ:
We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.
We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology.
We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies.
Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter.The Senior Manager, Pharmacology Scientist directs, leads, and manages Jazz non-clinical Pharmacology projects from conceptualization and study design through to study report finalization and subsequent scientific publications, and inclusion in regulatory documentation.
Directs, leads and manages preclinical pharmacology projects and studies as determined by the needs of the organisation and in accordance with the appropriate Jazz, CRO or researchers SOPs, relevant regulatory guidelines, legislation, best industry and ethical practices, and departmental processes as required per study.
resolves a wide range of issues in creative ways.Operates independently to execute nonclinical project activities and may contribute to new product concepts and defining/optimizing development candidate profiles
Is accountable to propose, manage and revise (as appropriate) timelines for pharmacology studies and projects and for timely and effective management of the study and project budget
Manages interactions and collaboration with key internal and external CRO or academic stakeholders within non-clinical and across the wider organization including relevant key opinion leaders and academic research organizations; May be responsible for delegation to others, matrix leadership and/or representing Neuroscience Research on r nonclinical research teams or nonclinical functional matrix teams as required.
Defines and manages non-clinical pharmacology study/programme resource needs and establishes relevant contingency/risk mitigation plans.Manage the material requirement for the Jazz Pharmacology studies to ensure that materials are always available
Manage and provide technical input into scientific reports from CROs/AROs
Contribute to regulatory, pharmacovigilance and medical affairs documents as required to meet corporate needs
Contribute to Function and/or Programme (pre-DP0) or Project (post-DP0) Teams as determined within the governance matrix structure
With support from functional leadership, is accountable for devising, agreeing, implementing and monitoring pharmacology team departmental processes and governance structures.
Operates in an inclusive manner and demonstrates awareness of the benefits of diversityA minimum of 5 years' research experience in Pharmacology department of a pharmaceutical company or equivalent setting
Knowledge of the pharmaceutical drug development process
Extensive knowledge of in vivo / in vitro pharmacology, behaviour and translational readouts of preclinical assays/models.
Relevant experience in scientific writing for externalisation (e.g. peer-reviewed scientific publications) and regulatory purposes
Competence in budgetary control and management
A degree (BSc) and either higher degree (PhD or MSC) in Pharmacology or another appropriate scientific discipline or equivalent significant drug discovery experience (Neuroscience)
Jazz Pharmaceuticals is an Equal Opportunity Employer.
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