- Bachelors Degree in a scientific or clinical area and 3 years experience in pharmaceutical or CRO industry or in pharmaceutical or CRO industry, or 5+ years experience in pharmaceutical or CRO and at least 3 years experience in medical affairs
- Two more years' experience with clinical research or managed access as a study manager or CRA, or other applicable experience
- Previous experience managing compassionate use or early access programs
- Background in oncology
- Prior clinical project management or expanded access program experience
- Proven success working in a team setting and contributing to team success
- Proven ability to work with a high level of integrity, accuracy, and attention to detail
- Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
- Strong problem solving skills
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
- Comfortable with ambiguity and has the ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions
- Self-motivated, assertive, and self-confident, with the ability to act with urgency and passion
- Flexible, resourceful, creative, enthusiastic, and results-oriented
- Enjoys working in a fast-paced environment
- Understanding of cross-functional stakeholder key responsibilities (Supply Chain, Regulatory, PV, Legal, Medical Writing, LOC Medical Leads, etc.)
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expanded access coordinator, oncology - Waltham, MA, USA, United States - GSK
Description
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.The Expanded Access Coordinator (Oncology) is responsible for providing operational support for Managed access Programs, including Compassionate Use, Expanded Access, and Post Trial access. As part of the Managed Access Team, the Coordinator Managed Access will be responsible for establishing strong relationships with internal cross functional teams including local medical teams, supply, finance and governance teams, as well as communication with HCPs and other external stakeholders.
Key Responsibilities:
• Set up and manage operational support for access programs from planning through close out, including such activities as invoice and PO management, GSK CTMS systems, vendor communications, IP stock and delivery, as well as the tracking of documents, agreements, contracts and key correspondence. This role interacts with many internal and external cross functional teams.
• Work closely with the internal global and local medical affairs teams and cross functional stakeholders to deliver Managed Access Programs.
• Provide day to day management of compassionate use and expanded access programs:
• Provide program coordination including status tracking, IP management, document management and data review activities in accordance with, regulatory requirements and Good Clinical Practice and Good Manufacturing Process
• Management of vendors to support access execution
• Coordinate activities associated with management of expanded access activities, including document collection, filing and archiving, and collection of timelines and metrics to ensure timely and quality deliverables
Provide regular status updates on program utilization to internal stakeholders
• Collaborate with CMC and other functional areas to plan, forecast and management clinical supply as requested by program leads
• Develop project materials and tools to support effective operationalization and communication
• Proactively identify potential delivery issues and risks and ensures corrective actions in case of deviation, communicates to stakeholders
• Track milestones and timelines
• Continually support/help develop department initiatives and process improvements
• Identifies needs for process standardization and regulatory compliance direction
Basic Qualifications:
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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