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

New

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 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

Director, Global Medical Lead – Lysosomal Storage Disorders

The Global Medical Lead, Director level, is a critical leadership role in Global...

Location

Switzerland

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

MD, PhD, PharmD or other advanced life sciences degree required
Extensive industry experience, especially in Medical Affairs (≥ 7 years) and Clinical Development, ideally in global role with experience in Genetic Medicine or LSDs/Rare Disease inherited metabolic conditions
Ability to work, influence, and gain consensus across regions and cross-functional teams
Demonstrate solid understanding of cross-functional inter-dependencies across the drug development lifecycle
Excellent communication skills and a strong enterprise mindset required for problem solving and high-level presentations for senior executive staff review
US and international experience working in orphan or specialty markets
Knowledge and hands-on skills required to develop the strategy, framework, and scientific content for a wide range of post marketing studies
Knowledgeable and current in GCP guidelines and compliance rules globally
Clinical trial and publication experience is desirable
Track record of successfully influencing without authority, partnering across functions especially with but not limited to Commercial

Job Responsibility

In partnership with the Commercial organization, co-develops the Integrated Brand Plan (IBP), as core member of the 3M (Medical – Marketing – Market Access) Team
Offers scientific and medical expertise to inform the overall product strategy, contributing to clinical development, commercialization, and market access plans
Leads development, execution, and communication of the Global Medical Plan in collaboration with other internal stakeholders across BioMarin
Provides subject matter expertise as well as strategic leadership in key internal medical and clinical teams
Act as product and disease area expert and primary contact point for all global compound or disease area related issues both internally and for the external community
Partner with other departments, such as commercial, finance, and clinical development, to ensure that the medical affairs budget supports and aligns with overall business goals
Develop Medical Affairs launch strategy and roadmap and lead all Medical Affairs launch activities in collaboration with Commercial and other key stakeholders
Represent Medical Affairs in the development of regulatory documents and submissions
Represent Medical Affairs at FDA/EMA meetings
As a core member of the Integrated Evidence Team, contributes to the development of the integrated evidence package for therapeutic area

New

Bookkeeper

Are you detail-oriented, organized, and skilled in managing financial records? R...

Location

United States , Walnut Creek

Salary:

33.00 - 38.00 USD / Hour

Robert Half

Expiration Date

Until further notice

Requirements

Proven experience as a bookkeeper or similar role
Proficiency in accounting software such as QuickBooks, Sage, or equivalent tools
Solid understanding of accounting principles and bookkeeping best practices
Proficiency in Microsoft Excel (e.g., data entry, formulas, and pivot tables)
High level of accuracy and attention to detail in maintaining financial records
Strong organizational, analytical, and communication skills

Job Responsibility

Record day-to-day financial transactions, ensuring accurate and timely entry
Process accounts payable and accounts receivable, including invoices, payments, and reconciliations
Balance and maintain general ledgers
reconcile bank and credit card statements regularly
Generate and prepare financial statements, including profit-and-loss reports and balance sheets
Resolve discrepancies in financial records and inquiries from vendors or clients
Assist with month-end and year-end financial processes

What we offer

medical, vision, dental, and life and disability insurance
eligible to enroll in our company 401(k) plan

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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February 20, 2026