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Non-Clinical Pharmacology Document Specialist Assistant
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Cambridge, Massachusetts |
About this job
Org Marketing Statement
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.
Role Description
Responsible for electronic publishing and production of regulatory submissions that conform to regional (ICH) and country specific regulatory requirements. The range of submission types include, but are not not limited to, INDs, CTAs, NDAs, MAAs, sNDAs, etc. (low-to-high complexity), labeling submissions, periodic reports including marketing renewals, and responses to agency queries. Accountable for ensuring that regulatory submissions of all types, formats and complexities are generated consistent with business priorities and regulatory requirements.
Ensure that NonClinical Pharmacology documentation is compliant with regulatory requirements/guidelines and meets Pfizer Global Style Guidelines using appropriate document management tools. Liaise with global NonClinical Pharmacology Submission Managers, colleagues and partner lines (DSRD, Regulatory, and PDM) to drive continuous improvement in document management processes at all sites.
* Key subject matter expert for Submission Ready initiatives, submission formatting requirements, and document management workflows.
* Supports colleagues on use of Submission Ready templates, act as subject matter expert for SR formatting and support documentation needs during regulatory filings.
* Manage submission requests and workload based on information provided from the NonClinical Pharmacology Submission Managers.
* Ensure document formatting is aligned with regulatory submission standards. Responsible for ensuring single native document formatting meets Submission Ready Standards (e.g., ensuring fonts, tables, auto field's bookmarks, and hyperlinks meet MS Word SRC Standards; redistilling of PDF's received from third parties), and ensuring a single PDF renditions formatting and navigations meet Submission Ready Standards
* Serve as GDMS Document Coordinator for NonClinical Pharmacology Submission Managers and enters documents into document management system. Select appropriate object type, enter attributes, update formatting if necessary, generate PDF version with appropriate navigations, and issue document.
* Collaborate with NonClinical Pharmacology Submission Managers, NonClinical Pharmacology Submission Scientist colleagues, DSRD and PDM to share knowledge, align expectations and establish action plans to prepare submission documentation for publishing.
* Ensure Pfizer Global Style Guide and RuleBook requirements are met.
* Conduct submission ready QC review and ensure data QC has occurred on all documents included in regulatory submissions.
* Perform critical evaluation of CTD (esp. Module 2.4 and 2.6) submission structures for logic, suitability and compliance with regional requirements. May assist in generating tabular summaries of data to be included in a regulatory submission.
* Participates and manages projects to implement new versions and interim updates of the Pfizer Submission Ready Templates (PREDICT).
* Promote utilization, maintenance, and improvement of tools and document management systems used in regulatory submissions.
* Contribute to SOP content related to document management and submission readiness processes.
* Review performance standards and serve a critical role in technology, process improvement, and other operational initiatives that are related to or interface with the regulatory submission processes/systems.
Responsibilities
STUDY SUPPORT
* Collaborate with NonClinical Pharmacology Submission Managers and NonClinical Pharmacology scientist to ensure that appropriate information is included in NonClinical Pharmacology study reports and are in electronic submission ready format.
DOCUMENT MANAGEMENT
* Lead efforts to ensure creation and maintenance of regulatory acceptable templates for regulatory submission and study related components.
* Support e-archivist activities by ensuring accurate archiving of Pfizer electronic documents.
* Educate colleagues on archiving requirements and processes. Streamline processes for data retrieval of legacy dossiers.
* Serve as Global Document Management System Expert and Document Business Line Researcher.
ADDITIONAL DUTIES
* Promote quality as a best practice within NonClinical Pharmacology based on knowledge of regulatory requirements, departmental guidelines, and QC experience.
* Support Acquisition, Collaboration and Divestiture activities, document and data transfers and interface with Business Development and NonClinical Pharmacology NCP Submission Managers.
* Foster training and development of colleagues in the application of technologies and tools to support study and regulatory submission document publishing.
Organizational Relationships:
* Reports to WRD Non-Clinical Pharmacology Reporting and Compliance Manager
* Worldwide Safety and Regulatory Organization
* WRD Research Units
Qualifications
Education and Experience:
* Prefer 5 + years of regulatory or quality assurance experience in pharmaceutical industry.
* Prefer BS in Business Administration, Regulatory Compliance, Information Technology or Scientific (i.e. Biology) related field.
* Experience with FDA interactions, international regulations, submissions, inspections, and successful track record with outcomes.
* Experience of technical or scientific aspects of NonClinical Pharmacology submissions, have competency using Documentum (web-top and workspace configurations), Adobe Acrobat, ISI Toolbox, MS Word, and SharePoint.
* Experience with eCTD principles and requirements for Module 2.4 and 2.6 compliance in various regional markets, as well as functional understanding of XML language is desired.
* Familiarity with Module 2.4 and 2.6 document types, source systems and general knowledge of the NonClinical Pharmacology business as it relates to drug development, and partnering organizations and systems.
* Have proficiency in the above systems, evidenced by the ability to independently and efficiently resolve/manage technical errors in the following applications such that deliverables are not compromised.
* Solid knowledge of regulatory requirements, relevant ICH guidelines, and country-specific requirements related to NonClinical Pharmacology and Regulatory Submissions.
* Strong project management skills, document management and coordination experience in pharmaceutical industry.
* Ability to train in accordance with Regulatory Training curriculum (SOP's, Policies).
* Excellent communication (written and verbal) and interpersonal skills, with the ability to communicate to multiple layers of the organization.
* Ability to manage multiple projects simultaneously.
* Work independently to problem solve, multi-task, be resourceful, and work in fast-paced team environment.
* Proven track record of initiating and driving continuous improvements within function and internal processes.
Technical Skills Requirements:
* Software: Microsoft Office Suite.
* Advanced MS Word and Excel competency is a must.
* Advanced understanding of Adobe Acrobat.
* Advanced understanding and hands on experience with Electronic Document Management Systems (i.e. GDMS/Documentum).
* Strong understanding of submission requirements and tools.
* Excellent computer skills and word processing skills are necessary.
* Prior experience working with SRC, document templates, working knowledge of MS Word, Adobe Acrobat, and Excel are required.
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.
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.
Role Description
Responsible for electronic publishing and production of regulatory submissions that conform to regional (ICH) and country specific regulatory requirements. The range of submission types include, but are not not limited to, INDs, CTAs, NDAs, MAAs, sNDAs, etc. (low-to-high complexity), labeling submissions, periodic reports including marketing renewals, and responses to agency queries. Accountable for ensuring that regulatory submissions of all types, formats and complexities are generated consistent with business priorities and regulatory requirements.
Ensure that NonClinical Pharmacology documentation is compliant with regulatory requirements/guidelines and meets Pfizer Global Style Guidelines using appropriate document management tools. Liaise with global NonClinical Pharmacology Submission Managers, colleagues and partner lines (DSRD, Regulatory, and PDM) to drive continuous improvement in document management processes at all sites.
* Key subject matter expert for Submission Ready initiatives, submission formatting requirements, and document management workflows.
* Supports colleagues on use of Submission Ready templates, act as subject matter expert for SR formatting and support documentation needs during regulatory filings.
* Manage submission requests and workload based on information provided from the NonClinical Pharmacology Submission Managers.
* Ensure document formatting is aligned with regulatory submission standards. Responsible for ensuring single native document formatting meets Submission Ready Standards (e.g., ensuring fonts, tables, auto field's bookmarks, and hyperlinks meet MS Word SRC Standards; redistilling of PDF's received from third parties), and ensuring a single PDF renditions formatting and navigations meet Submission Ready Standards
* Serve as GDMS Document Coordinator for NonClinical Pharmacology Submission Managers and enters documents into document management system. Select appropriate object type, enter attributes, update formatting if necessary, generate PDF version with appropriate navigations, and issue document.
* Collaborate with NonClinical Pharmacology Submission Managers, NonClinical Pharmacology Submission Scientist colleagues, DSRD and PDM to share knowledge, align expectations and establish action plans to prepare submission documentation for publishing.
* Ensure Pfizer Global Style Guide and RuleBook requirements are met.
* Conduct submission ready QC review and ensure data QC has occurred on all documents included in regulatory submissions.
* Perform critical evaluation of CTD (esp. Module 2.4 and 2.6) submission structures for logic, suitability and compliance with regional requirements. May assist in generating tabular summaries of data to be included in a regulatory submission.
* Participates and manages projects to implement new versions and interim updates of the Pfizer Submission Ready Templates (PREDICT).
* Promote utilization, maintenance, and improvement of tools and document management systems used in regulatory submissions.
* Contribute to SOP content related to document management and submission readiness processes.
* Review performance standards and serve a critical role in technology, process improvement, and other operational initiatives that are related to or interface with the regulatory submission processes/systems.
Responsibilities
STUDY SUPPORT
* Collaborate with NonClinical Pharmacology Submission Managers and NonClinical Pharmacology scientist to ensure that appropriate information is included in NonClinical Pharmacology study reports and are in electronic submission ready format.
DOCUMENT MANAGEMENT
* Lead efforts to ensure creation and maintenance of regulatory acceptable templates for regulatory submission and study related components.
* Support e-archivist activities by ensuring accurate archiving of Pfizer electronic documents.
* Educate colleagues on archiving requirements and processes. Streamline processes for data retrieval of legacy dossiers.
* Serve as Global Document Management System Expert and Document Business Line Researcher.
ADDITIONAL DUTIES
* Promote quality as a best practice within NonClinical Pharmacology based on knowledge of regulatory requirements, departmental guidelines, and QC experience.
* Support Acquisition, Collaboration and Divestiture activities, document and data transfers and interface with Business Development and NonClinical Pharmacology NCP Submission Managers.
* Foster training and development of colleagues in the application of technologies and tools to support study and regulatory submission document publishing.
Organizational Relationships:
* Reports to WRD Non-Clinical Pharmacology Reporting and Compliance Manager
* Worldwide Safety and Regulatory Organization
* WRD Research Units
Qualifications
Education and Experience:
* Prefer 5 + years of regulatory or quality assurance experience in pharmaceutical industry.
* Prefer BS in Business Administration, Regulatory Compliance, Information Technology or Scientific (i.e. Biology) related field.
* Experience with FDA interactions, international regulations, submissions, inspections, and successful track record with outcomes.
* Experience of technical or scientific aspects of NonClinical Pharmacology submissions, have competency using Documentum (web-top and workspace configurations), Adobe Acrobat, ISI Toolbox, MS Word, and SharePoint.
* Experience with eCTD principles and requirements for Module 2.4 and 2.6 compliance in various regional markets, as well as functional understanding of XML language is desired.
* Familiarity with Module 2.4 and 2.6 document types, source systems and general knowledge of the NonClinical Pharmacology business as it relates to drug development, and partnering organizations and systems.
* Have proficiency in the above systems, evidenced by the ability to independently and efficiently resolve/manage technical errors in the following applications such that deliverables are not compromised.
* Solid knowledge of regulatory requirements, relevant ICH guidelines, and country-specific requirements related to NonClinical Pharmacology and Regulatory Submissions.
* Strong project management skills, document management and coordination experience in pharmaceutical industry.
* Ability to train in accordance with Regulatory Training curriculum (SOP's, Policies).
* Excellent communication (written and verbal) and interpersonal skills, with the ability to communicate to multiple layers of the organization.
* Ability to manage multiple projects simultaneously.
* Work independently to problem solve, multi-task, be resourceful, and work in fast-paced team environment.
* Proven track record of initiating and driving continuous improvements within function and internal processes.
Technical Skills Requirements:
* Software: Microsoft Office Suite.
* Advanced MS Word and Excel competency is a must.
* Advanced understanding of Adobe Acrobat.
* Advanced understanding and hands on experience with Electronic Document Management Systems (i.e. GDMS/Documentum).
* Strong understanding of submission requirements and tools.
* Excellent computer skills and word processing skills are necessary.
* Prior experience working with SRC, document templates, working knowledge of MS Word, Adobe Acrobat, and Excel are required.
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.
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