Investigator Initiation Package Senior Associate Job at Pfizer (Makati City)

Senior Specialist, QA External Manufacturing

The Senior QA Specialist – External Manufacturing is responsible for ensuring qu...

Location

Italy , Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related field
3–5+ years of experience in a GMP Quality Assurance role within the pharmaceutical or CHC industry
Experience in external manufacturing or supplier quality (strongly preferred)
Solid knowledge of EU/FDA GMP regulations, ICH guidelines, and quality management systems
Strong ability to review complex documentation with accuracy and attention to detail
Problem-solving skills with experience in root cause analysis
Excellent communication skills to effectively interface with internal stakeholders and external partners
Ability to manage multiple priorities and work independently with moderate supervision
Familiarity with digital quality tools and AI applications
Proficiency in English

Job Responsibility

Serve as the primary QA contact for assigned CMOs, monitoring performance through quality metrics, documentation review, and regular governance meetings
Support batch review and release activities, ensuring thorough evaluation of manufacturing and packaging records, analytical results, deviations, and associated changes
Review and manage deviations, investigations (including OOS/OOT), and CAPAs, ensuring scientific soundness, robustness, and timely closure
Assess change controls from CMOs, collaborating with cross-functional teams (Regulatory, MS&T, Supply Chain, Procurement) to ensure compliant implementation
Participate in internal audits, CMO audits, and regulatory inspection readiness activities, following up on corrective actions
Maintain and update Quality Agreements to reflect current operations and compliance requirements
Drive continuous improvement initiatives related to quality systems and external manufacturing performance
Support technology transfers, scale-ups, and new product introductions from a QA perspective
Partner with Technical Operations and MS&T to enhance processes and product quality

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Packaging & Labeling Artwork Specialist

Colleague fundamentally performs the ePALMS system “Market Coordinator” role in ...

Location

China , Shanghai

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor’s degree in an appropriate discipline, plus 4-6 years work experience related to Artwork Change Control processes
Must be familiar with Biopharmaceutical Regulatory environment and cGMPs associated with manufacturing, packaging & distribution processes as well as a basic understanding of Artwork & Labeling regulations and controls
Must be able to collaborate with cross-functional Pfizer teams, negotiate across globally distributed affiliates and manufacturing site personnel, and communicate across multiple levels of the organization in a clear professional manner
Solid PC business software skills including document authoring, spreadsheet, database management, and presentation applications are required
Strong written and verbal communication skills required
Strong English language skills are required of non-native English speaking colleague to enable global interactions
Must be able to work under pressure of tight timelines, apply sound judgment in ambiguous business situations, appropriately assess issues for potential impacts and ability to escalate if/as needed
Demonstrate organizational skills
In-depth knowledge of PGS manufacturing and site processes/requirements
Must have capacity to solicit input in ambiguous business situations, resolve conflicting feedback and make appropriate business decisions

Job Responsibility

Initiation and “build” of Pfizer Artwork Requests (PARs) in collaboration with markets, assuring all required information, specifications and/or supportive documentation is available for plants/Artwork Centers to execute the production of product labeling related packaging components
Coordinating Artwork Change Control logistics across multiple Pfizer departments to assure Regulatory timelines for implementation are met and that product supply is not interrupted
Tracking Artwork Key Performance Indicators (KPIs) (e.g. volume, timelines, and/or quality metrics) for assigned projects
Support for large-scale Artwork Change Control projects with broad portfolio impact under the direction of more senior ALIM staff
Research into root cause assessments for internal ALIM Quality Investigations or Area Quality Review Team (AQRT) meetings and potential process improvement recommendations
Retrieve documents and/or generate reports in response to queries from Regulatory Agencies (e.g. inspections) or Assistant General Counsel (e.g. product litigation cases related to labeling in distribution)
Liaises with markets and stakeholders to gather all necessary information to initiate and “build” PARs (according to local or regional requirements) to enable plant production of Labeling Artwork with minimal rework and to meet implementation requirements
May create Editor’s Copy (EC) for select markets depending on language(s) involved and specific “custom” services negotiated with markets in line with local SOPs
Liaises with GRO GLM/IL functions, GRS/PCOs and PGS PCOs, or demand management lines to coordinate any unique factors that need to be considered
documents agreement on Artwork timelines across stakeholders

Fulltime

Senior Associate Quality Assurance

The Senior Associate Quality Assurance role at NTT DATA involves ensuring the pe...

Location

Indonesia , Jakarta Selatan

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Hands-on experience managing platforms, including ErP, Middleware, and other business-critical software
Moderate experience in managed services with knowledge of using ticketing tools like ServiceNow
Ability to handle multiple tasks, execute change management duties, and lead troubleshooting processes effectively
Ability to plan activities and adapt quickly to changing circumstances
Effective communication skills and the ability to work across different cultures and social groups
Active listening skills to understand clients' needs and craft a positive client experience
Capacity to maintain a positive outlook, even in a pressurized environment, and put in extra effort when necessary
A bachelor’s degree in information technology/computing or equivalent work experience

Job Responsibility

Ensure that our clients' packaged application technologies, such as ErP and Middleware, are always in top shape
Proactively monitor, investigate, and resolve application-based incidents, service requests, and alerts
Handle second-line support with a medium level of complexity, focusing on resolving client requests and issues without breaching any service level agreements (SLAs)
Update tickets with resolution tasks
Log incidents promptly
Communicate with other teams and clients to extend support
Execute changes carefully and ensure that all changes are properly documented and approved as part of the change management process
Work with automation teams to optimize efforts
Coach Service desk and L1 teams
Lead initial client escalations for operational issues

What we offer

Workplace embraces diversity and inclusion
A place where you can grow, belong and thrive
Part of a global company with experts in more than 50 countries

Fulltime

Senior Operations Associate

We are seeking an Senior Operations Associate who takes ownership and drives out...

Location

Australia

Salary:

Not provided

Eucalyptus

Expiration Date

Until further notice

Requirements

3-4 years experience in a supply chain, operations, consulting, or strategy role or in a fast-paced, ambiguous environment
Exceptional analytics and problem-solving skills
Excellent communication skills and an ability to build strong working relationships with internal stakeholders, carriers and suppliers
Strong organisation and decision making skills, with experience running end-to-end projects
Resilience and ability to take initiative and drive outcomes in our constantly-changing fast-paced environment
Ability to work openly, challenge respectfully, share insights freely and own your mistakes
Passion for changing healthcare to improve the lives of patients

Job Responsibility

Act as the primary point of contact internally owning day-to-day logistics, resolving delivery issues, investigating delays, returns and damages, and coordinating fixes with couriers and pharmacies
Manage courier relationships, including performance issues, escalations, evaluation of alternative courier options, trials and ongoing change
Drive cost improvements across logistics and fulfilment, with clear tracking of savings and impact on cost per order
Enhance the delivery experience, identifying and delivering on opportunities to improve delivery speed, reliability, flexibility and convenience for patients
Work closely with the Operations Lead on step-change improvement projects to scale the national network, covering packaging strategy, scaling our capacity as order volumes grow, cost optimisation, and public-holiday and peak-period planning
Work cross-functionally including with Patient Experience, Finance and Medical Support teams among other teams to deliver logistics changes that scale without breaking cost or experience

What we offer

Equity for everyone
Access learning budgets, conferences, certifications, peer shadowing, and a global knowledge-sharing culture
Catered wellness talks, exercise classes, whoops to track your wellbeing, free barista coffees, funded social clubs, and quarterly rooftop parties
Parental and miscarriage leave, to health, professional development, and personal days, Whoop membership, and our Employee Assistance Program

Fulltime

Senior Medical Writer - FSP

As a Medical Writer at Parexel, your strong scientific knowledge, writing skills...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP
Extensive clinical/scientific writing skills
Scientific background essential
writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar
Advanced word processing skills, including MS Office (expertise in Word)
software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel)
Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation
Excellent interpersonal, verbal, and written communication skills
Ability to consistently produce documents of high quality

Job Responsibility

Author Clinical Documents: Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy
Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input
Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable
Perform literature searches/reviews as necessary to obtain background information and training for development of documents
Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing
Quality Control: Ensure that all work is complete and of high quality prior to team distribution or shipment to client
Confirm data consistency and integrity across the document
Prepare documents for publishing readiness, when applicable
Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable
Provide suggested alternative content when contributors provide content that does not meet document needs

What we offer

Foster a culture of inclusivity, collaboration, and support
Continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team
Development and promotion based on global standards and your personal development plan
Supportive and inclusive environment
Career growth and development
Mentorship
Flexible work
Diverse projects
Culture of excellence
Global exposure

Senior Systems Engineer

Analyzes user's requirements, concept of operations documents, and high-level sy...

Location

United States , Annapolis Junction

Salary:

Not provided

Columbia Technology Partners

Expiration Date

Until further notice

Requirements

U.S. Citizenship is required for all applicants
All applicants and employees are subject to random drug testing in accordance with Executive Order 12564
Employment is contingent upon successful completion of a security background investigation and polygraph
This position requires an active Security Clearance with appropriate Polygraph
Fourteen (14) years experience as a SE in programs and contracts of similar scope, type and complexity is required
Bachelor's degree in System Engineering, Computer Science, Information Systems, Engineering Science, Engineering Management, or related discipline from an accredited college or university is required
Five (5) years of additional SE experience may be substituted for a bachelor's degree

Job Responsibility

Analyzes user's requirements, concept of operations documents, and high-level system architectures to develop system requirements specifications
Analyzes system requirements and leads design and development activities
Guides users in formulating requirements, advises alternative approaches, and conducts feasibility studies
Provides technical leadership for the integration of requirements, design, and technology
Incorporates new plans, designs and systems into ongoing operations
Develops technical documentation
Develops system Architecture and system design documentation
Guides system development and implementation planning through assessment or preparation of system engineering management plans and system integration and test plans
Interacts with the Government regarding Systems Engineering technical considerations and for associated problems, issues or conflicts
Ultimate responsibility for the technical integrity of work performed and deliverables associated with the Systems Engineering area of responsibility

What we offer

Medical: CTP offers 3 superior plans, bringing our employees both in-network and out-of-network options
Vision + Dental: Both free to you + paid in full by CTP
Retirement: 401k - 6% company contribution
PTO + Leave: A work life balance is extremely important to our team here at CTP, which is why our paid time off plans are so lucrative. Offering customizable leave plans to meet your needs is just one of our many perks! Jury Duty, Bereavement + Military Leave provided
Career Growth: Up to $10,000 provided for approved career-related learning, training, education, and/or tuition
Life and AD&D Insurance/Short-Term & Long-Term Disability: More peace of mind, at zero cost to you
Profit Sharing Bonus: End of year cash gets added to your bottom-line
Referral Bonus Program: Our tiered program provides an incentive with each stage of the hiring process your referral passes. Our bonuses range from $7,000-$20,000, if your referral joins the team

Fulltime

Senior Systems Engineer

Analyzes user's requirements, concept of operations documents, and high-level sy...

Location

United States , Annapolis Junction

Salary:

Not provided

Columbia Technology Partners

Expiration Date

Until further notice

Requirements

Fourteen (14) years experience as a SE in programs and contracts of similar scope, type and complexity is required.
Bachelor's degree in System Engineering, Computer Science, Information Systems, Engineering Science, Engineering Management, or related discipline from an accredited college or university is required.
Five (5) years of additional SE experience may be substituted for a bachelor's degree.
U.S. Citizenship is required for all applicants.
All applicants and employees are subject to random drug testing in accordance with Executive Order 12564.
Employment is contingent upon successful completion of a security background investigation and polygraph.
This position requires an active Security Clearance with appropriate Polygraph.

Job Responsibility

Analyzes user's requirements, concept of operations documents, and high-level system architectures to develop system requirements specifications.
Analyzes system requirements and leads design and development activities.
Guides users in formulating requirements, advises alternative approaches, and conducts feasibility studies.
Provides technical leadership for the integration of requirements, design, and technology.
Incorporates new plans, designs and systems into ongoing operations.
Develops technical documentation.
Develops system Architecture and system design documentation.
Guides system development and implementation planning through assessment or preparation of system engineering management plans and system integration and test plans.
Interacts with the Government regarding Systems Engineering technical considerations and for associated problems, issues or conflicts.
Ultimate responsibility for the technical integrity of work performed and deliverables associated with the Systems Engineering area of responsibility.

What we offer

Medical: CTP offers 3 superior plans, bringing our employees both in-network and out-of-network options.
Vision + Dental: Both free to you + paid in full by CTP.
Retirement: 401k - 6% company contribution
PTO + Leave: A work life balance is extremely important to our team here at CTP, which is why our paid time off plans are so lucrative. Offering customizable leave plans to meet your needs is just one of our many perks! Jury Duty, Bereavement + Military Leave provided.
Career Growth: Up to $10,000 provided for approved career-related learning, training, education, and/or tuition.
Life and AD&D Insurance/Short-Term & Long-Term Disability: More peace of mind, at zero cost to you.
Profit Sharing Bonus: End of year cash gets added to your bottom-line.
Referral Bonus Program: Our tiered program provides an incentive with each stage of the hiring process your referral passes. Our bonuses range from $7,000-$20,000, if your referral joins the team.

Fulltime

System Engineer 1

Analyzes user's requirements, concept of operations documents, and high level sy...

Location

United States , Annapolis Junction

Salary:

Not provided

Columbia Technology Partners

Expiration Date

Until further notice

Requirements

Seven (7) years experience as a SE in programs and contracts of similar scope, type and complexity is required
Bachelor's degree in System Engineering, Computer Science, Information Systems, Engineering Science, Engineering Management, or related discipline from an accredited college or university is required
Five (5) years of additional SE experience may be substituted for a bachelor's degree
U.S. Citizenship is required for all applicants
All applicants and employees are subject to random drug testing in accordance with Executive Order 12564
Employment is contingent upon successful completion of a security background investigation and polygraph
DOD 8570 Certification
This position requires an active Security Clearance with appropriate Polygraph

Job Responsibility

Analyzes user's requirements, concept of operations documents, and high level system architectures to develop system requirements specifications
Analyzes system requirements and leads design and development activities
Guides users in formulating requirements, advises alternative approaches, and conducts feasibility studies
Provides technical leadership for the integration of requirements, design, and technology
Incorporates new plans, designs and systems into ongoing operations
Develops technical documentation
Develops system Architecture and system design documentation
Guides system development and implementation planning through assessment or preparation of system engineering management plans and system integration and test plans
Interacts with the Government regarding Systems Engineering technical considerations and for associated problems, issues or conflicts
Ultimate responsibility for the technical integrity of work performed and deliverables associated with the Systems Engineering area of responsibility

What we offer

Medical: CTP offers 3 superior plans, bringing our employees both in-network and out-of-network options
Vision + Dental: Both free to you + paid in full by CTP
Retirement: 401k - 6% company contribution
PTO + Leave: Offering customizable leave plans to meet your needs
Jury Duty, Bereavement + Military Leave provided
Career Growth: Up to $10,000 provided for approved career-related learning, training, education, and/or tuition
Life and AD&D Insurance/Short-Term & Long-Term Disability: at zero cost to you
Profit Sharing Bonus: End of year cash gets added to your bottom-line
Referral Bonus Program: Our bonuses range from $7,000-$20,000, if your referral joins the team

Fulltime

Investigator Initiation Package Senior Associate

Pfizer

Location:
Philippines , Makati City

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 20, 2026

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