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Associate Scientist, Compliance Oversight (non

Pfizer


Location:
Groton, CT
Date:
11/15/2017
2017-11-152017-12-16
Pfizer
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Job Details

A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.







Working under the direction of management, the Associate Scientist will be responsible for ensuring the Pharmacokinetics, Dynamics and Metabolism (PDM) local and global standard operating procedure (SOP) processes and systems are maintained, managed and administered in accordance with defined departmental procedures and GLP/GCLP expectations. Responsible for Power 2 Learn (P2L) training administration and maintaining PDM quality oversight of the training program and reporting of training metrics for the regulated as well as non-regulated areas within PDM. Accountable for ensuring colleague training record files are kept current and accurate; this includes record retention management and oversight of colleague Job Descriptions and CV's. Act as Trial Master File (TMF) Document Owner for PDM, accountable for ensuring PDM required documentation meets TMF readiness criteria and are filed timely to PTMF, in accordance with defined TMF policies and associated CT01-GSOP processes and procedures. Act as a catalyst between TMF Study Owners and PDM bioanalytical (BA) colleagues to facilitate document transfer to TMF as appropriate. Ensuring accurate archiving of Pfizer electronic documents in accordance with defined departmental procedures.







**MAIN RESPONSIBILITIES**



STANDARD OPERATING PROCEDURES (SOPs) AND DOCUMENT MANAGEMENT







+ Manage and administer processes and systems associated with PDM SOPs, P2L Training, and business objects. Activities performed to ensure consistency of PDM SOP Management and system architecture include; SOP revision and review, tracking of SOP expiration timelines, timely communication to all personnel regarding SOP implementation, change, or suspension of any SOPs, as well as ensuring proper access to current SOPs.



+ Manage PDM SOP compliance mailbox and respond in a timely manner to all questions and work to resolve issues in order to ensure compliance with regulatory expectations.



+ Serve as a P2L administrator with the ability to create learning courses, job curricula and apply appropriate training assignments.



+ TMF Document Owner accountable for submitting PDM required document types to PTMF and liaising with PDM BA scientists to remediate and resolve issues found during TMF QC process.



+ Ensure PDM colleague training record files are maintained and kept current to reflect colleague's respective job roles and responsibilities. Conduct oversight of Job Description and CV records to ensure they are maintained in accordance with WWPDM SOP 29 procedure on the management of the PDM Training Program and Colleague Training Records.



+ Support e-archivist activities by ensuring accurate archiving of Pfizer electronic documents through use of the Central Index of Company Records (CICR) tool. Educate colleagues on archiving requirements and processes. Streamline processes for data retrieval of legacy dossiers.



+ Serve as Global Document Management System (GDMS) Document Coordinator and Document Long Term Storage Business Line Researcher.



+ Support in/out-licensing activities related to document and data transfers



+ Foster training and development of colleagues in the application of technologies and tools to support study and regulatory submission document publishing







REGULATORY SUBMISSIONS







+ Support PDM Submission leads in ensuring the Module 4 study reports are submission ready and compliant with eCTD requirements (ensure Pfizer Global Style Guide and Rule Book requirements are met).



+ Lead efforts to ensure creation and maintenance of regulatory acceptable templates in GDMS for regulatory submission and study related components.



+ Participate in advancement of technology, process improvement, and other operational initiatives that are related to or interface with the regulatory submission processes/systems.



+ Contribute to SOP content related to document management and submission readiness processes.



+ May conduct QC review of documents included in regulatory submissions.







**BASIC QUALIFICATIONS**







+ Bachelor's Degree with 0-2 years of experience in the pharmaceutical industry.



+ Use of document management, training and archival systems such as: Documentum, Adobe Acrobat, ISI Toolbox, Microsoft Office, Sharepoint, GDMS, P2L, Business Objects, and CICR.



+ Experience with regulatory submission document principles and requirements is desired.



+ Proficiency in administering systems such as the above, evidenced by the ability to independently and efficiently resolve/manage technical errors in applications such that deliverables are not compromised.



+ An awareness of the requirements (relevant Food and Drug Administration [FDA] and International Council for Harmonization [ICH] guidelines and country-specific requirements) related to regulatory submissions.



+ Demonstrate problem solving skills and issue resolution.



+ Communicate straightforward information, ask questions and check for understanding.



+ Use existing communication materials to explain information and persuade others in straightforward situations.



+ Ability to communicate and influence/negotiate effectively (orally and in writing) with colleagues at all levels of the PDM organization, as well as across Pfizer Research lines.







**ADDITIONAL OFFER DETAILS**







+ **Last Date to Apply for Job: December 12, 2017**



+ **This is Pfizer Exempt US Grade: 002**



+ **Location: Groton, CT**



+ Eligible for Employee Referral Bonus: Yes







**EEO & Employment Eligibility**



Pfizer 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







**Sunshine Act**



Pfizer 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.







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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