Medical Affairs Manager

GW Pharmaceuticals ,
London, Greater London
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Overview

Job Description

About GW Pharmaceuticals GW Pharmaceuticals is a cutting-edge UK-based biopharmaceutical company that over the last 20 years has established a world-leading position in cannabinoid science and the development of regulatory approved medicines derived from cannabis. Our mission is to transform the lives of seriously ill patients and their families. In October 2018 our achievements were recognized by TIME magazine which named GW as one of the 'Top 50 Genius companies of 2018 that are inventing the future'. Having developed the world's first prescription medicine derived from the cannabis plant, Sativex, which treats spasticity due to multiple sclerosis,GW has now developed an oral formulation of purified cannabidiol (CBD), (approved as Epidyolex in Europe) for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.Lennox-Gastaut syndrome or Dravet Syndrome are two rare and severe early-onset, drug-resistant epilepsy syndromes. CBD is approved in the US as Epidiolex. This is in addition to our deep pipeline of clinical stage cannabinoid candidates under development for both orphan and non-orphan indications with a particular focus on neurological conditions. In the UK, we have close to 550 employees from a diverse range of backgrounds and disciplines based on four sites in Cambridge, Kent, London and Andover, along with employees working in the field. We also have a strong presence in the U.S. with around 250 U.S. employees, based both in Carlsbad, CA and in the field. We are continuing to build out our teams and are looking for talented individuals with an entrepreneurial spirit, dedicated to making a difference in the lives of our patients, and to exemplifying our company values. Please go to www.gwpharm.com for additional information. Job Purpose To work as part of a team to support EAP/Compassionate Use and other access programs at GW International. Working with the other team members to manage logistical aspects of investigator initiated trial study applications and projects, and GW sponsored real world evidence studies. Key Responsibilities * The team is the key point of contact for EAPs for internal stakeholders at GW (e.g. Medical Affairs, Supply Chain, Pharmacovigilance (PV), Legal, Commercial, QA) and external service providers (eg,regulatory partners), global distributor * Working closely with the International Market Access VP and Medical Director, International Medical Operations to implement and deliver the programs effectively and efficiently * Leading regular EAP core team meetings to update internal stakeholders at GW and external service providers and discuss any issues arising * Act as central point for receipt and tracking of IIT concepts/proposals and project manage logistical aspects of IIT/RWE studies, as central point of contact Detailed Responsibilities EAP/other access programs * Providing logistical assistance relating to project set-up with the country affiliates and global distributor * Providing support for queries and problem solving for the country affiliates and global distributor * Preparing documentation and materials, as required, to help understanding of the program logistics * Providing training for the country affiliates on the processes involved with the programs (e.g. registration of institutions, physicians, patients) * Reviewing documentation for the programs (e.g. global distributor registration forms) * Arranging meetings to communicate key information to the country affiliates, e.g. start-up of programs * Working closely with GW Supply Chain; preparing, reviewing and approving labels and leaflets for patient packs * Preparation of submissions to regulators, and dealing with enquires and questions from regulators, in a timely manner * Managing the EAP inbox; triaging and following-up on queries, as appropriate and in a timely manner * Reviewing weekly reports from global distributor and cascading relevant information to key stakeholders * Liaising with GW Demand and Forecasting to ensure global distributor has sufficient stock of product for the program * Working with GW Medical Information to ensure external enquires on the EAP are addressed * Working with GW QA to ensure audits of external service providers are conducted, as required * Working with GW PV to ensure all PV requirements are met for the program, and GW reporting forms are provided to the country affiliates * Working with Medical Affairs to obtain compliance approval of documentation and materials, as required * Facilitating contracts review and sign-off for external service providers with GW Legal, and other key stakeholders (e.g. PV for Safety Data Exchange Agreements) in a timely manner * Facilitating discussions between key stakeholders to ensure the program is progressing as expected * Obtaining translations of local language documentation for the program, and arranging review o

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