Early Access Program, Senior Manager/Associate Director job in Maidenhead, England

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First Name*

Last Name*

Email*

Phone Number*

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First Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Medical Manager

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting an Early Access Program, Senior Manager/Associate Director for a pharmaceutical corporation. This role is on a permanent basis and is located in Maidenhead. The client is focused on discovering treatments that could alter the lives of patients living with illnesses with limited options for remedies.

Responsibilities:

Accountable for inspecting any delivery and/or cold chain nonconformities and CAPA execution in a timely fashion.
Assist and follow EAP drug supply planning and shipping actions.
To assist coordination and preservation of standard functional progresses for early access programs, you will collaborate with legal and compliance.
Handle information on intranet and Box/internal databases.
Support in handling relations with the EAP supplier/assisting suppliers to efficiently implement the allocated tasks.
To assist with reviews and inspections, the ideal candidate will collaborate with the company's GPRSRM and QA.
Preserve the Quality Technical Agreement and Safety Management Plan for all EAP/CUP programs.
Responsible for supporting the evolvement and analysis of explicit EAP/CUP reports such as informed consent forms, treatment procedures, Pharmacy Manuals, training supplies.
To initiate implementation of crucial initiatives and enable decisiveness, you will organise evolvement plans and uphold supervision of action items from internal program teams and supplier conferences.
For new and current patients, the ideal candidate will handle the daily access requests.
When suitable, you will enable the closing of EAP/CU countries.
To follow actions and milestones rendering to the performance of EAP/CUP, you will efficiently and operatively interact with internal, clinical site and supplier employees.
Exhibit solution resolving abilities, involving the active recognition of mattered and suggested solutions, in deliberation with senior management.
The ideal candidate will support the evolvement of action plans to acknowledge guideline compliance, safety, data and administrative matters with sits and assisting suppliers.
You will attend team conferences, receive and deliver meeting minutes and follow action substances.
Other duties may be assigned to the role.

Skills & Requirements:

Educated to a degree level in a life science or similar discipline.
Working experience within a pharmaceutical or biotech industry, in clinical operations and/or medial affairs.
Familiarity with regulatory protocols/directives as well as drug development and clinical research procedures.
Ideally knowledgeable in Early Access and Compassionate Use.
Able to swiftly evolve working know-how of new therapeutic areas.
Capable of handling and following multiple multifaceted projects simultaneously while handling the activities of many personnel towards shared results.
Communication skills with the ability to form work associations.
Self-motivated and results-oriented individual with the ability to be conclusive, flexible and produce high-quality work to surpass in a vastly expanding and fluctuating setting.
Experience collaborating with all levels of management as well as deliberate with crucial shareholders.
Works well in a team environment with the ability to be client- and solution-oriented.
High attention to detail with the capability to work well self-sufficiently and with external associates and suppliers.
Organised and translucent.
Computer literacy with MS Office Suite such as Excel, Word and PowerPoint as well as MS Project.

If you are having difficulty in applying or if you have any questions, please contact Ed White at +44 203 854 2622.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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