GlaxoSmithKline Hiring for Expanded Access Coordinator, Managed Access Programs and Research (Oncology) at Collegeville, PA  Full Time

371959 Expanded Access Coordinator, Managed Access Programs and Research (Oncology)

The Expanded Access Coordinator (Oncology) is responsible for managing the strategic and operational components of global medical affairs activities, with a focus on access programs (Compassionate Use and Expanded Access).

In this role you will

• Lead access program operations from planning through close out, including support for internal review and approval, budget assessment, safety reporting, vendor management, 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 global and local medical affairs teams and cross functional stakeholders to deliver patient access for designated GSK oncology products.
• Provide day to day management of compassionate use and expanded access programs:
  • Provide program coordination support including status tracking, IP management, safety reporting, document management and data review activities in accordance with, regulatory requirements and Good Clinical Practice
  • Management of vendors to support access execution
  • Lead and co-ordinate the development and management of expanded access protocol, regulatory document collection, timelines and metrics; ensures timely and quality deliverables
  • Partner with CMC and other functional areas to plan, forecast and management clinical supply (IP)
• Develop strategy, materials and tools to support streamlined and effective transition from Investigational Medicinal Product (IMP) to locally approved commercial presentations
• Proactively identify potential delivery issues and risks and ensures corrective actions in case of deviation, communicates to stakeholders
• Provide regular status and issues reports to Cross Functional Teams and Senior Management
• Proactively incorporates learnings and recommendations from one EAP to another; identify needs for process standardization and regulatory compliance direction

Closing Date for Applications: June 18th (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

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Why you?

Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Bachelors Degree in a Scientific discipline or equivalent
• Significant and varied experience in a pharmaceutical/CRO environment or alternatively some professional experience in a pharmaceutical/CRO environment and significant and demonstrable experience doing managed access work
• Direct experience with clinical research in a study manager or CRA role, or other applicable experience
• Thorough knowledge of FDA, ICH, GCP, and OIG guidelines.

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:

• 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.)

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.