Vacancy caducado!
ROLE SUMMARYIndividuals filling the position are responsible for providing deep subject matter expertise and strong execution/delivery in the management of regulatory information. The scope of applications covers both regulatory strategy and regulatory operations. The incumbent will be responsible and leading medium to large scale information management projects to drive efficiency and value for the Regulatory. Incumbent will work closely with functional lines in regulatory to understand their needs and articulate them so we can make active decisions. The incumbent will partner with Pfizer Digital to execute projects and deliver robust solutions.ROLE RESPONSIBILITIES
Ideation - work closely with functional lines to articulate business needs for new solutions or changes to existing solutions.Run workshops, conduct interviews, etc in order to understand the business need.
Document options and proposals for solution governance on how best to meet customer needs
Requirements - Document business requirements for regulatory solutions.Run workshops, conduct interviews with functional line SMEs to ensure full and complete requirements set.Ensure endorsement from functional lines
Drive impact assessments of business requirements and technical changes which include the identification of processes and applications, required changes to these processes and applications, and alternatives to mitigate impact.
Collaborate with functional lines to understand and document the use of the information management solutions with the business process
Coordinate user testing and acceptance of information solutions prior to deployment
Work with regulatory stakeholders to listen to their needs and articulate into projects and provide ongoing status on progress of key projects
Lead continuous improvement projects to simplify and improve system use and system management.
Lead medium to large projects with a medium length duration, following established methodologies
Collaborate with functional lines to ensure a consistent approach with business process-specific training.
Drive active decision making through pre-existing governance with a complex set of stakeholders.
BASIC QUALIFICATIONS
BS in Computer Science, Life Sciences, Business, engineering, statistics or a related discipline
Minimum 7 years pharmaceutical industry experience in (or supporting) any of the following disciplines: clinical drug development, clinical trial management, safety surveillance and reporting, clinical project management, R&D or regulatory reporting and analytics, or regulatory affairs. Related experience in other industries will be considered.
Demonstrated strong analytical skills with demonstrated ability to investigate and solve problems
Demonstrated Knowledge of application system management and change control processes, application validation and implementation in a GxP environment.
Demonstrated strong customer relationship skills and capabilities to collaborate with teams.
Proven ability to communicate complex information and analyses to a variety of audiences in both verbal and written format.
PREFERRED QUALIFICATIONS
MS in Computer Science, Life Sciences, Business, engineering, statistics or a related discipline
Minimum of 5+ years of project and/or program management experience
Graduate degree
A comprehensive understanding of data and systems used in the R&D processes.
Proven technical aptitude with software used in Regulatory (for example tracking, document management, submission publishing tools).
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.#LI-PFEOther Job Details:
Additional Location Information: Peapack NJ, Collegeville PA, Groton CT, Sandwich UK, Walton Oaks UK
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Vacancy caducado!