Senior Associate CSR

Makati City - Philippines

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

This team ensures PfizersClinical Study Report(CSR)managementmeetsglobal agency standards and manages regulatory reporting dossier development and submission activities for Global Regulatory & International Operations (RIO).Members in the teamoverseeandmanageend-to-end lifecycledevelopmentof CSRto support Pfizers global drug registration and approval processes including submission publishing and archiving of related reports and documents.

Lead the coordinationcompilation quality controlapprovaland post-approval processes associated with development of Pfizer global CSRs

Create CSR mockups in System and populate document templates

Project manage CSR compilationapprovaland publishing activities

Execute submission readyQuality Control (QC)on CSR components and structure

Communicate with function linesregardingissues with CSR components and seek resolutions

Seek approval from signatories onfinalizedCSRs and update clinical trial registry with CSR milestone status

Prepare investigators declaration packages for distribution to the coordinating investigator

Prepare study data packages required for distribution to studyPrincipal Investigators(PIs)

CoordinatePublic Disclosure Synopsis(PDS)andPlain Language Summary(PLS)activities

Publishes the approved report into Pfizer standard submission-ready and regulatory compliant package and contributes to submission package

Files the report to Trial Master Files(TMF)system to meetregulatory requirements

Monitor public mailbox

Provide ongoing quality reviews and process improvement suggestions to the work group or project team supporting continuous enhancement of CSR coordination practices

Senior Associate (cumulative from above)

Serve as the subject matter expert for specific CSR coordination business areas authoring andmaintaininglocalClinicalAndMedical Controlled Document (CMCD)/Standard Operating Procedure(SOP)/QC checklists and managing document and email templates

Act as the system business administrator and primary point of contact for related processes

Independently leads moderately complex CSR projects and process improvement initiatives providing guidance and mentorship to newly appointed CSR Coordinators where appropriate

Facilitate cross-departmental collaboration to streamline workflows build consensus and implement optimized CSR processes regularly taking informal leadership roles to drive group agreements and progress.

Ensure proper workload distribution by factoring in team capacity and capability while managing personal time to meetobjectivesfor departmental projects

Provide ongoing quality reviews and process improvement suggestions to the work group or project team supporting continuous enhancement of CSR coordination practices

maintain compliance and uninterrupted operations

Build the bridge across internal and external stakeholders to shareCSR relatedregulations(e.g.International Council forHarmonisationof Technical Requirements for Pharmaceuticals for Human Use(ICH)E3) and be the leading voiceof the team

Skill Requirements:

In-depth knowledge of drug development process
Independent delivery of all phases CSR for all Theraputic Areas (TAs) and advanced CSRs
Great CSR timeline management capability and decent CSR coordination communication skills
Demonstrated coordination of activities in a highly regulated environment and mastery of concurrent taskmanagement
Demonstrate an understanding of applicable filing regulatory guidelines and fluency regarding order andpresentation of regulatory dossiers
In depth knowledge of regulatory guidance data standards and practices pertaining to technological aspectsof submission management and publishing
Experience of successfully mentoring others
Demonstration of experience working in a customer service environment
Preferred skills in electronic submissions builds and/or publishing within the Pharmaceutical Industry
Preferred ability to troubleshoot independently and resolve technical issues efficiently

QUALIFICATIONS

Masters or bachelors degree in biological medical pharmaceutical sciences or life sciences preferred
Proficiency in English and Chinese language preferred (read written and spoken)

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

Regulatory Affairs

Required Experience:

Senior IC

Lead the coordinationcompilation quality controlapprovaland post-approval processes associated with development of Pfizer global CSRs

Create CSR mockups in System and populate document templates

Project manage CSR compilationapprovaland publishing activities

Execute submission readyQuality Control (QC)on CSR components and structure

Communicate with function linesregardingissues with CSR components and seek resolutions

Seek approval from signatories onfinalizedCSRs and update clinical trial registry with CSR milestone status

Prepare investigators declaration packages for distribution to the coordinating investigator

Prepare study data packages required for distribution to studyPrincipal Investigators(PIs)

CoordinatePublic Disclosure Synopsis(PDS)andPlain Language Summary(PLS)activities

Publishes the approved report into Pfizer standard submission-ready and regulatory compliant package and contributes to submission package

Files the report to Trial Master Files(TMF)system to meetregulatory requirements

Monitor public mailbox

Provide ongoing quality reviews and process improvement suggestions to the work group or project team supporting continuous enhancement of CSR coordination practices

Senior Associate (cumulative from above)

Serve as the subject matter expert for specific CSR coordination business areas authoring andmaintaininglocalClinicalAndMedical Controlled Document (CMCD)/Standard Operating Procedure(SOP)/QC checklists and managing document and email templates

Act as the system business administrator and primary point of contact for related processes

Independently leads moderately complex CSR projects and process improvement initiatives providing guidance and mentorship to newly appointed CSR Coordinators where appropriate

Facilitate cross-departmental collaboration to streamline workflows build consensus and implement optimized CSR processes regularly taking informal leadership roles to drive group agreements and progress.

Ensure proper workload distribution by factoring in team capacity and capability while managing personal time to meetobjectivesfor departmental projects

Provide ongoing quality reviews and process improvement suggestions to the work group or project team supporting continuous enhancement of CSR coordination practices

maintain compliance and uninterrupted operations

Build the bridge across internal and external stakeholders to shareCSR relatedregulations(e.g.International Council forHarmonisationof Technical Requirements for Pharmaceuticals for Human Use(ICH)E3) and be the leading voiceof the team

Skill Requirements:

In-depth knowledge of drug development process
Independent delivery of all phases CSR for all Theraputic Areas (TAs) and advanced CSRs
Great CSR timeline management capability and decent CSR coordination communication skills
Demonstrated coordination of activities in a highly regulated environment and mastery of concurrent taskmanagement
Demonstrate an understanding of applicable filing regulatory guidelines and fluency regarding order andpresentation of regulatory dossiers
In depth knowledge of regulatory guidance data standards and practices pertaining to technological aspectsof submission management and publishing
Experience of successfully mentoring others
Demonstration of experience working in a customer service environment
Preferred skills in electronic submissions builds and/or publishing within the Pharmaceutical Industry
Preferred ability to troubleshoot independently and resolve technical issues efficiently

QUALIFICATIONS

Masters or bachelors degree in biological medical pharmaceutical sciences or life sciences preferred
Proficiency in English and Chinese language preferred (read written and spoken)

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

Regulatory Affairs

Required Experience:

Senior IC

Key Skills

Business Development
Organizational Management
GAAP
Accounting
Analysis Skills
Meeting Facilitation
Microsoft Powerpoint
Investment Banking
Microsoft Excel
Private equity
Financial Modeling
Writing Skills

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About Company

Pfizer

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