Qualification Requirements
- 5 GCSEs at grades C/4 or above (or equivalent) including mathematics and English.
- You must have gained a minimum of 96 UCAS points from a minimum of 2 A Level subjects or equivalent
Salary - £20,000 per annum
Benefits
- Holiday Allowance - 25.5 Days Holiday Allowance, plus Bank Holidays
- Pension - Employee 5%, Employer 3%
- Annual Salary Review
- Casual Dress
- Employee Assistance Programme
- Onsite Parking
- Onsite Canteen
- Employee Recognition/Awards
Location - Sandwich, Kent
Working Hours Monday to Thursday, 9am – 5:25pm with 45 minute lunch break. Fridays, 9am – 4:05pm with 45 minute lunch break
Duration - 48 months
Start Date - 1st September 2025
Interview Date - 18th March 2025
Closing Date for Applications - 23rd February 2025
To Apply
To apply, please click the Apply Now button and complete the form. If you are having difficulty in completing this, please contact recruitment on recruitment@cogentskills.com for assistance.
Job Description
As part of the Clinical Trials Regulatory Operations Team (CTRO), the Clinical Trial Submission Manager (CTSM) is accountable for supporting the operational submissions execution for designated Clinical Trials. The role is part of a global organization responsible for the delivery of submissions to Regulatory Health Authorities & Central Ethics committees to enable the delivery of Study Start up activities required for patients to participate in clinical Trials. CTRO has a strong focus on Project management driving accelerated timelines for delivery. This role would suit future project managers, medical students, Information management, or business skills. The CTSM may be assigned as a Hub Submission Manager to meet business demands.
Main Duties
- Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate. Partnering with regional or global CT SMs/or third-party partners, the incumbent will be accountable for supporting submission activities, for the Clinical Trial submission build and delivery.
- Supports delivery project specific Pfizer Clinical Trial submissions. Including coordination and execution of solutions that meet unique requirements of each submission and national market, management of product delivery to regulatory agencies and ensuring subsequent archival.
- Partners with other team members on initiatives and non-portfolio projects.
- Ongoing liaison country representatives to ensure submission requirements, translation requirements and timelines are mutually comprehended and in line with corporate standards and deadlines for dossier delivery to regional and national markets.
- Completion of assignments and tasks within a specific project associated with CT submissions.
- Adhere to the appropriate use of technical tools, through use of working practices and Quality Control/Quality Assurance regimes, such that regulatory and internal compliance is preserved.
- Promotes the use of Document Management and Archival systems and standard document authoring and publishing processes, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.
Candidate Requirements
Skills
- Ability to adapt to an ever-changing business environment
- Ability to learn and adapt quickly to change
- Ability to generate creative and innovative ideas
- Enthusiasm and pro-active attitude
- Strong organizational and project management skills
- Technical awareness
- Excellent analytical and problem-solving skills
Personal Qualities
- Ability to work independently and as part of a team
- High level of attention to detail
- Adaptable, with a willingness to learn
- Self-motivated
Training To Be Delivered
Qualification to be delivered: BSc Project Manager
Apprenticeship Standard: Level 6 Project Manager
Training Provider: Cumbria University
Delivery model: Online
Future Prospects
Upon successful completion of the apprenticeship, you will be eligible to apply for other positions within the business.
Things To Be Considered
The apprentice must be able to demonstrate the required attitudes, behaviours and interpersonal skills associated with the professional workplace. The apprentice must be willing to commit an amount of personal time to study. Please ensure you check out travel options to be able to commute to the workplace.
About Pfizer
You’re the future. Your ambition, talents, ideas and unique way of looking at the world will help us drive innovation in every part of our business. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. We need people with a hugely diverse range of talents. “Love Science? Want to work on the business side? Get stuck into an apprenticeship to launch your career. Pfizer’s apprenticeship scheme, run in partnership with Cogent Skills, offers the best of both worlds. You’ll work with world-leaders in your field, from researchers to business gurus. You’ll study towards a nationally recognised academic or professional qualification. And all the time, you’ll be earning a highly competitive salary. Looking for an alternative to college or university, where you can earn while you learn, and build experience with a global leader? Find it at Pfizer.About this role
Pfizer (Sandwich)
Ramsgate Road
Sandwich
CT13 9NJ
