Senior Manager - Clinical Trial Applications

Employer
Pfizer
Location
New York City, New York
Posted
Sep 29, 2021
Ref
4826739
Required Education
Masters Degree/MBA
Position Type
Full time

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. 

Provides 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.

Drives global submission management activities for their assigned assets. Partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables associated with CTA submission development and execution for designated assets and/or geographies.

 Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities

 Support and leads global team efforts to ensure high quality components and
submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
 Liaises with Study Management, regarding essential core documents that cross both HA and EC submission and translation processes
 Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
 Responsible for the co-ordination of translations for core documents required for submission
 Manages the compilation for core package build, contributing to CTA and authoring documentation as required
 Acts as Subject Matter Expert for Regulatory Operations and provides country-level intelligence on clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the CTR team, is maintained on the central repository, e.g., Competent Authority submission requirements

Self-initiates assignments, developing innovative ideas to resolve complex problems and leading the execution of projects

Senior Manager (qualitative examples)
 Significant knowledge of the drug development process, Regulatory Affairs and submissions management.
 Demonstrated understanding of regional and national regulator filing guidelines and dossier requirements.
 Demonstrated ability to lead and deliver through others in a matrix model
 Demonstrated ability to deliver swift decision in ambiguous or urgent circumstances
 Robust organizational management skills
 Advanced knowledge of the processes, systems and regulatory guidance and a detailed understanding/knowledge of principles and concepts of other disciplines
 Proven ability to embrace new technologies and processes and drive their implementation

Required Experience:

B.S./B.Sc with 9 + years experience- Desirable degrees in Pharmacy, Life Sciences, Business or Information Technology

or Master's Degree with 7 years experience.
 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

  
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Other Job Details:


    
Last Date to Apply for Job: 10/15/21
    Additional Location Information: United States - New York - New York City; United States - Pennsylvania - Collegeville;
    NO Relocation Package 
    Eligible for Employee Referral Bonus 

   

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