Clinical Trial Submission Manager

Pfizer

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