• Job Description

  Req#: 4890065

  Clinical Trial Submission Manager

  Job Description

  Why Patients Need You

  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.

  What You Will Achieve

  You will be responsible for directing the development, quality control and publication of submissions relating to asset development and registration, driving adherence to external regulatory guidelines and compliance timelines for multiple submission types. Providing strategic direction to teams on regulatory logistics, you will serve as a regulatory operational liaison on the project team throughout the product lifecycle. You will coordinate timely provision of product information through submissions that conform to external and internal requirements, authoring and redacting content as applicable based on external regulations and submitting product information to regulatory authorities. 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.

  Qualifications Must-Have

  • Bachelor's Degree (BA/BS) and extensive experience.

  • Significant knowledge of the drug development process, Regulatory Affairs and submissions management.

  • Strong verbal and written communication skills. • Advanced Microsoft Office Suite skills and strong competency with tools (tools to be added by Hiring Manager).

  • Understanding of systems and electronic technologies used to support submission and planning activities.

  
  Nice-to-Have

  • Master's degree(MA/MBA/MS) and relevant experience.

  • Doctorate (PhD/PharmD/JD).

  • Knowledge of pharmaceutical organizational structures, systems and culture

  • Strong knowledge of the drug development process, regulatory affairs, Clinical Trial Applications and submissions management.

  
  Work Location Assignment: Remote

  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.

  DisAbility Confident

  We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

  Regulatory Affairs

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

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