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Pfizer
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Groton, Connecticut
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fulfil Pfizer's regulatory commitments.
ROLE RESPONSIBILITIES
The RWE Platform ... ) regulatory document, study report, and publication preparation and review, and 6) clinical study
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Pfizer
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Groton, Connecticut
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Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, Market Access, Business Assessment & Development ... a trusted expert as assigned with study / analytical KOLs, key regulatory agencies (e.g., FDA in the
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Pfizer
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Groton, Connecticut
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sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval ... , regulatory, study management, pre-clinical, pharmacology, quality assurance.
Demonstrates a passion for
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Pfizer
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Groton, Connecticut
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aspects of drug development, also comfortable in discussing commercial and regulatory issues ... regulatory agencies (FDA, EMA, MHRA, etc.) regarding pharmaceutical indication and/or labeling issues
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Pfizer
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Groton, Connecticut
...
, regulatory, safety and GXP
Strong verbal, written communication and presentation skills
**Nice-to ... disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends
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Pfizer
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Groton, Connecticut
...
for public disclosure. Subject to further legal review and statutory or regulatory clarification
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Pfizer
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Groton, Connecticut
...
standards and regulatory requirements.
Data review Functions:
Work with Study Team to define ... with clinical study management, data management, and regulatory operations.
Project management
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Pfizer
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Groton, Connecticut
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levels of Pfizer's governance. You will apply your talent to uncover, identify business, regulatory and ... changing needs of the business, industry trends, competitive activities, and regulatory environment
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Pfizer
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Groton, Connecticut
...
disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends
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Pfizer
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Groton, Connecticut
...
and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting
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Pfizer
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Groton, Connecticut
...
disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends
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Pfizer
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Groton, Connecticut
...
effectiveness which are pivotal to fulfil Pfizer's regulatory commitments.
**ROLE RESPONSIBILITIES ... and communication, 5) regulatory document, study report, and publication preparation and review, and 6
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Pfizer
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Groton, Connecticut
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practices and regulatory approaches related to Pathology
Develop and maintain strong, effective ...
Role Responsibilities
Performs all regulatory responsibilities in compliance with applicable
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Pfizer
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Groton, Connecticut
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strategy, regulatory documentation, safety, and compliance in the delivery of robust and high-quality ... development, regulatory submission and new product launch. Serves as CRD Accountable Manager to ensure one or
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Pfizer
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Groton, Connecticut
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development programs intended for regulatory approvals of new products and currently approved products ... regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed
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Pfizer
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Groton, Connecticut
...
, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification
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Pfizer
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Groton, Connecticut
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markets, where the evidence will be used to respond to regulatory commitments / requests, HTA/government ... experience,
Experience assisting regulatory experts with new drug applications with FDA and EMA
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Pfizer
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Groton, Connecticut
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and regulatory submissions.
Provides statistical input to study designs and can contribute to ... of results, and collaborate on the reporting of clinical trial results to regulatory authorities and
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Pfizer
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Groton, Connecticut
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regulatory responsibilities of the applicable local regulations and AAALAC International guidelines. Some ... assure the quality of site operations and regulatory compliance.
Interact with in vivo scientists to
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Pfizer
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Groton, Connecticut
...
, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification
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Pfizer
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Groton, Connecticut
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throughout the animal facilities. There is regular interaction with colleagues fulfilling the key regulatory ... , and training documents to assure the quality of site operations and regulatory compliance
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Pfizer
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Groton, Connecticut
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development in a global matrix organization.
Detailed knowledge of clinical trial and regulatory ... , generally for public disclosure. Subject to further legal review and statutory or regulatory clarification
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Pfizer
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Groton, Connecticut
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all levels of the organization.
Author relevant sections of global regulatory submissions in ... for public disclosure. Subject to further legal review and statutory or regulatory clarification
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Pfizer
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Groton, Connecticut
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research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
Proficient experience using ... regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed
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Pfizer
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Groton, Connecticut
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, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process ... diverse needs of different regulatory requirements of different sites and countries.
Ability to lead
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Pfizer
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Groton, Connecticut
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Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements ... , generally for public disclosure. Subject to further legal review and statutory or regulatory clarification
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Pfizer
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Groton, Connecticut
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Assurance Audits and Regulatory Inspections (e.g., Pfizer, Pfizer Ignite Partner/ study sponsor), CRO/Vendor ... ), monitoring, clinical, and regulatory operations.
Extensive experience in clinical study and/or vendor
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Pfizer
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Groton, Connecticut
...
regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed
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Pfizer
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Groton, Connecticut
...
disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends
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Pfizer
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Groton, Connecticut
...
and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting
...
