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Clinical Trial Submission Manager (Senior Associate)
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Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

POSITION SUMMARY
You will support the operational submissions execution for designated Clinical Trial Submissions. You will be the regulatory operational Subject Matter Expert for a Clinical Trial Application and drive submission teams towards the timely delivery of globally compliant submission-ready components.

KEY RESPONSIBILITIES

  • Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate.
  • Partner with regional or global Clinical Trial Senior Managers and/or third-party partners, to support submission activities for the Clinical Trial submission build and delivery.
  • Deliver project specific Pfizer electronic and paper regulatory Clinical Trial submissions.
  • Support other team members on initiatives and non portfolio projects
  • Participate in the definition, investigation, and implementation of national, regional and global process efficiencies for paper and electronic Clinical Trial submission execution, including the evaluation of current processes

 BASIC QUALIFICATIONS

  • Masters degree in a pharmaceutical or related life sciences discipline or
  • Bachelors degree in a pharmaceutical or related life sciences discipline, business discipline or Information Technology and a minimum of 2 years relevant pharmaceutical and/or clinical experience
  • Proficiency with Microsoft Office
  • Basic knowledge of ICH/GCP and EU Clinical Trial Directive
  • Basic understanding of EU Clinical Trial Regulation
  • Familiarity with pharmaceutical organizational structures, systems, and culture
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
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Clinical Trial Submission Manager (Senior Associate)
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