Senior Associate CSR
- Malaysia - Kuala Lumpur
- Philippines - Manila
This team ensures Pfizer's Clinical Study Report (CSR) management meets global agency standards and manages regulatory reporting, dossier development, and submission activities for Global Regulatory & International Operations (RIO). Members in the team oversee and manage end-to-end lifecycle development of CSR to support Pfizer’s global drug registration and approval processes, including submission, publishing, and archiving of related reports and documents.
Associate
Lead the coordination, compilation, quality control, approval and post-approval processes associated with development of Pfizer global CSRs
Create CSR mockups in System and populate document templates
Project manage CSR compilation, approval and publishing activities
Execute submission ready Quality Control (QC) on CSR components and structure
Communicate with function lines regarding issues with CSR components and seek resolutions
Seek approval from signatories on finalized CSRs 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 study Principal Investigators (PIs)
Coordinate Public Disclosure Synopsis (PDS) and Plain 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 meet regulatory 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 and maintaining local Clinical And Medical 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 meet objectives for 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 share CSR related regulations (e.g. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E3), and be the leading voice of the team
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory AffairsBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)