Hub Labeling Senior Associate(1 Year Contract)
- Korea, Republic of - Seoul
JOB SUMMARY
Senior Associate Is responsible for executing the content management of non-complex Local Product Documents (LPDs), Local Label Documents (LLDs) and Patient Leaflets (PLDs) for nationally registered products for their assigned products across multiple countries/regions.
Provides associated labeling support to the rest of the ILG organisation, working in collaboration with Hub Labeling Managers.
JOB RESPONSIBILITIES
• Supports Hub Labeling Manager (Manager) by maintaining system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system. Maintenance of workflow management tools and mailboxes.
• Provides ad hoc support for labeling deliverables.
• Performs QC of labeling text.
• Monitors system data integrity and quality checks.
• To maintain system management for labeling activities including GDMS and Pfizer approved labeling tracking system.
• Contributes to the completion of moderately complex projects under the direction of more senior labeling managers.
• Utilizes regulatory knowledge to produce non-complex LPDs, LLDs and PLDs where there are unambiguous relationships to source documents and clear local regulatory principles to follow, requesting advice or input from other functions when appropriate.
• Produces other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supporting documentation.
• Performs QC check of other colleagues’ work.
• Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
• Meets defined targets on productivity, quality and compliance, as set by and overseen by management.
QUALIFICATIONS / SKILLS
SKILLS
• Basic knowledge/understanding of the principles and concepts of labeling.
• Basic knowledge of key regulatory and labeling principles and local regulations.
• Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures.
• Fluency in English language important however multi-language skills are advantageous.
• Clear and effective written and verbal communications.
• Understanding of the importance of SOPs, systems and processes in underpinning quality and compliance of deliverables.
• Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access.
• Knowledge of key regulatory and labeling principles and local regulations.
QUALIFICATIONS
• Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
EXPERIENCE -Required
• Demonstration of attention to detail and problem-solving skills.
• Proven technical aptitude and ability to quickly learn new software.
• Proven technical aptitude and ability to quickly learn regulations and standards.
• ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs; preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs.
• Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label.
• Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important.
EXPERIENCE - Preferred
• Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
• Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
• Demonstrated project management, attention to detail and problem-solving skills.
• Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
ORGANIZATIONAL RELATIONSHIPS
• Reporting relationship to Regional Labeling Head and International Labeling Team Lead.
• Partners with Pfizer PCO’s, GRS groups, GRO groups and other platform lines as required.
• Supports global, GRS, GRO and ILG initiatives as required.
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)