Regulatory Project Manager, Regulatory Information Management

Posted:
7/31/2024, 8:28:32 PM

Location(s):
Greater Poland Voivodeship, Poland ⋅ Poznan, Greater Poland Voivodeship, Poland ⋅ Masovian Voivodeship, Poland

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
Business & Strategy

Regulatory Project Manager, Regulatory Information Management - the role purpose is to lead the planning and execution of remediation projects, ensuring compliance with regulatory requirements, RIM standards, and best practices. This role is critical in addressing non-compliance issues, mitigating risks, and safeguarding the organization's reputation and operational integrity.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

  • Acts as (SPOC) Single point of contact for issues arising on projects within remit of role and takes complete accountability in bringing them to appropriate resolution

  • Engage and negotiate on different parameters (eg: Timelines, process steps etc..) with stakeholders across GRA and the broader Development organization to meet internal project targets

  • Facilitates strategic discussions across functions and regions in order to continuously improve processes and efficiency

  • Identify, trouble shoot, report & address the issues coming up within existing and new processes

  • Independently manage multiple project assignments simultaneously, support challenges globally, develop project proposals and business cases to address the tactical and strategic needs of the business

  • Maintain knowledge of GSK standards and procedures associated with set of deliverables and contribute to the definition of new and revised procedures to improve quality and effectiveness

  • Proactively identifies gaps/risks in system or process and participate in quality or continuous process improvement activities related to area of responsibility or as requested

  • Critical thinking to generate new ideas & improve overall efficiency of regular activities without compromising overall quality

  • Provide operational support and strategic direction to GRA for Regulatory Operations, specifically the RIM Team

  • Monitor ongoing user requests and system activity to identify and act upon potential quality issues or process improvement opportunities

Why you?

Basic Qualifications:

  • Min Bachelor’s degree – Scientific or Technical

  • Excellent excel skills

  • English language skills

  • Strong experience in Veeva Vault and RIM processes

  • Understanding of regulatory procedures and their applicability within Regulatory

  • Ability to recognize problems and issues within RIM systems and how those affect regulatory and data management processes.

  • Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers

  • Strong interpersonal skills, ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment

  • Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines

Why GSK?

At GSK we offer a wide range of additional benefits: 

  • Hybrid work ( 2/3 days per week from the office)

  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

  • Sports cards (Multisport)

  • Private medical package with additional preventive healthcare services for employees and their eligible

  • Life insurance and pension plan

  • Supportive community and integration events

  • Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities). 

  • Possibilities of development within the role and company’s structure

  • Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

  • Modern office with creative rooms, fresh fruits every day

 

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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