Senior Manager - Clinical Trial Applications
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
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
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Regulatory Affairs#LI-PFE