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Our client is a leading research-based biopharmaceutical company. They apply science and their global resources to deliver innovative therapies that extend and significantly improve lives. Every day, colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
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
