The Clinical Trial Submission Manager (CTSM) is responsible for supporting the operational submissions execution for designated CT Submissions. They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components. The CTSM may be assigned as a Hub Submission Manager to meet business demands.
- B.S./B.Sc. in Pharmacy, Life Sciences, Business or Information Technology (desirable). Relevant professional experience will be considered.
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
- Understanding of ICH/GCP & EU Clinical Trial Directive Desirable
- Understanding of EU Clinical Trial Regulation Desirable.
- Familiarity with pharmaceutical organizational structures, systems, and culture is preferred
- Demonstrated coordination of activities in a highly regulated environment.
- Proven aptitude in project management and logistics.
- Demonstration of experience working in a challenging customer service environment.
- Proven experience managing or delivering through others in a team environment.
- Demonstrated attention to detail.
- Relevant experience in electronic submissions build within the Pharmaceutical Industry.
- Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers.
- Formal training in technical tools.
- Knowledge of drug development process.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To apply please visit our website www.pfizercareers.com and search job id 4879382 for Clinical Trial Submission Manager (Senior Associate)