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Clinical Trial Submission Manager
Pfizer
Fully Remote
role reference:  wyw_#00245
Location
Fully Remote
Salary
Competitive salary
Contract Full-time
Industry Pharmaceuticals
Hours 37.5 - 37.5 Hours
  • Pharmaceuticals
  • LIFE SCIENCES
  • LIFE SCIENCE
  • CLINICAL TRIALS
  • DRUG DEVELOPMENT PROCESS
  • DRUG DEVELOPMENT
Description:

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines. 

This role is being customized and will be part of a newly created 3-month certificated learning program, aimed to prepare successful candidates to become familiar with Clinical Trial Application processes and systems and the new EU Clinical Trial Regulation. In addition, this program include technical and leadership learning modules that will enhance professional leadership skills and create an environment that adopts a culture aligning to  Pfizer’s Values of Courage, Excellence, Equity and Joy

Reports to Head, CTA Liaison within GPD, Global Regulatory Operations, Submissions
Management

What You Will Achieve  

Provide an interface to Regulatory and GPD partners within designated Business Units,
offering project leadership and expertise in the logistics involved with execution of
regulatory CTA submissions to regional partners and selected Health Authorities.
The CTA Submission Manager (CTA-SM) is accountable for working with contributing
business lines to lead operational submissions execution for designated CTAs. 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 CTA-SM may be assigned as a Hub Submission Manager to meet business demands. In
this capacity, they may operate as Subject Matter Expert for a selected geography.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements and providing areas of improvement for products, processes, or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. 

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe. 

How You Will Achieve It 

  • Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the department. 

  • Drive global submission management activities for the assigned assets, prepare, review and submit submissions to relevant stakeholders, in order to obtain all necessary authorizations/approvals for the clinical trials. 

  • Coordinate submission production and assist with definition, development and implementation of global submissions policies and technologies to meet evolving business needs. 

  • Escalate, inform and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities. 

  • Promote the use of Document Management and Archival systems and standard document authoring, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components. 

  • Lead the interpretation of dossier requirements to produce business processes  and ensure that those processes are implemented where appropriate at global and local level. 

  • Implement strategies that achieve operational excellence through interaction with global regulatory leaders and associated product teams.​

  • Support leadership to produce business processes by understanding regulatory guidelines and requirements. 

​Manager (qualitative examples)

  • Proven aptitude in leadership, problem solving and logistics
  • Ability to work on multiple highly complex projects simultaneously.
  • Demonstrated attention to detail.
  • Strong knowledge of the drug development process, regulatory affairs, Clinical Trial
  • Applications and submissions management.
  • In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation. 
  • Ability to operate seamlessly and influence direct and indirect reports, as well as across organizations.

Qualifications 

  • B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable);
    equivalent relevant professional experience will be considered.
    In-depth understanding and proven execution of CTA processes globally
  • Proven technical aptitude and ability to quickly learn and use new software, regulations and
    quality standards
  • Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive
    Understanding of EU Clinical Trial Regulation Desirable
    Familiarity with pharmaceutical organizational structures, systems, and culture is preferred
Key skills:
  • Pharmaceuticals
  • LIFE SCIENCES
  • LIFE SCIENCE
  • CLINICAL TRIALS
  • DRUG DEVELOPMENT PROCESS
  • DRUG DEVELOPMENT
Competitive salary

CONTRACT

INDUSTRY

Role Type

37.5 - 37.5 Hours
Flexibility:
Working Patterns
Flexi-Time
Full-time
Flexibility:
Workplace
Remote or Mobile Working
Work From Home (WFH)
Flexibility:
Life event
Career Breaks / Sabbatical
Shared Parental Leave
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