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- Tasks: Lead the optimisation of clinical trial processes in R&D for pharmaceutical diagnostics.
- Company: GE HealthCare is a global innovator in medical technology and digital solutions.
- Benefits: Enjoy a supportive culture with career growth opportunities and competitive rewards.
- Why this job: Make a real impact in healthcare by enhancing compliance and quality in research.
- Qualifications: PhD, MSc, or BSc in a scientific discipline with relevant experience required.
- Other info: Join a diverse team where every voice matters and inclusion is key.
The predicted salary is between 44000 - 66000 £ per year.
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Job Description Summary
The main purpose of this role is to establish and optimize processes that ensure the effective management of clinical trials within Pharmaceutical Diagnostics, Imaging R&D. The position also focuses on enhancing the overall quality of systems and processes in pharmaceutical diagnostic research by identifying and resolving compliance issues.
Job Description Summary
The main purpose of this role is to establish and optimize processes that ensure the effective management of clinical trials within Pharmaceutical Diagnostics, Imaging R&D. The position also focuses on enhancing the overall quality of systems and processes in pharmaceutical diagnostic research by identifying and resolving compliance issues.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Responsibilities
Job Description
- Process Development and Optimization: Identify and establish processes that are \’fit for purpose\’ to support Pharmaceutical Diagnostics (PDx) R&D programs, focusing on clinical trials.
- Regulatory Compliance: Ensure business growth by simplifying processes and maintaining compliance with evolving regulatory environments. This includes creating new Standard Operating Procedures (SOPs) and rolling them out to relevant teams.
- Quality Enhancement: Identify and address compliance issues across R&D systems and processes to strengthen quality and maintain regulatory inspection readiness.
- SOP Management: Oversee and maintain the review cycle for R&D SOPs, working within the compliance team and collaborating cross-functionally with other departments as needed.
- Good Practices (GxP) Adherence: Ensure that all R&D activities adhere to relevant Good Practices (GxP) and Standard Operating Procedures (SOPs).
- Training Oversight: Support functional managers in training staff appropriately for their roles and ensure that training records are maintained as required.
- Compliance Reporting: Provide reporting metrics to disseminate compliance information across R&D teams.
- Audit Support: Contribute to the GxP audit schedule in collaboration with relevant R&D teams and Quality Assurance (QA). Lead and/or support GxP audits for both Contract Research Organizations (CROs) and internal departments.
- Regulatory Inspection Support: Assist with regulatory inspections and audits, including preparation, conduct, corrective/preventative action, and follow-up.
- Process Improvement: Proactively identify and implement process improvement initiatives within the R&D function.
- Risk Management: Collaborate with functional teams to identify and monitor risks, manage them within cost, quality, and time parameters, and develop contingency plans.
- GxP Expertise: Provide GxP expertise and advice to study and functional teams as needed.
- GxP Archivist: May act as a designated GxP Archivist or deputy as required.
- Document Management: Assist with the maintenance of the Document Management System (eTMF and Quality Vault), including upgrades, routine releases, access control, and training.
Qualifications
- Educational Background: PhD, MSc, or BSc in a scientific/medical discipline.
- Experience: Several years of experience in Clinical Research, Research, or an equivalent field.
- Regulatory Knowledge: A strong understanding of relevant Health Authority regulations, guidance, and the drug development process.
- Technical Skills: Ability to read and comprehend technical documentation, execute procedures, and understand system documentation.
- Organizational Skills: Strong organizational skills with high attention to detail.
- Computer Proficiency: Familiarity with industry-standard computerized system applications.
Desired Skills
- Teamwork: Strong teamwork, communication, and interpersonal skills.
- Problem-Solving: Demonstrable problem-solving abilities.
- Process Improvement Mindset: A strong passion for quality and a mindset focused on continuous process improvement.
- Multi-tasking: Ability to manage multiple priorities effectively and work well under pressure and time constraints.
- Document Management Systems Experience: Experience with Veeva or other document/information management systems is desired.
- Independence: Ability to work independently with minimal supervision.
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, g ender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Additional Information
Relocation Assistance Provided: No
Seniority level
-
Seniority level
Not Applicable
Employment type
-
Employment type
Full-time
Job function
-
Job function
Research, Analyst, and Information Technology
-
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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R&D Compliance Leader employer: GE Healthcare
Contact Detail:
GE Healthcare Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land R&D Compliance Leader
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines in clinical research and pharmaceutical diagnostics. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during interviews.
✨Tip Number 2
Network with professionals in the R&D compliance field, especially those who have experience with GE HealthCare or similar organisations. Engaging in conversations can provide insights into the company culture and expectations, which can be invaluable during the application process.
✨Tip Number 3
Prepare to discuss specific examples of how you've identified and resolved compliance issues in past roles. Being able to articulate your problem-solving skills and process improvement mindset will set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest trends and technologies in document management systems, particularly Veeva or similar platforms. Highlighting your proficiency in these systems can give you an edge, as they are crucial for maintaining compliance in R&D.
We think you need these skills to ace R&D Compliance Leader
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical research and compliance. Emphasise any roles where you've developed or optimised processes, as this is key for the R&D Compliance Leader position.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality and process improvement. Mention specific examples of how you've successfully managed compliance issues in previous roles, and align your skills with the responsibilities outlined in the job description.
Highlight Regulatory Knowledge: Since the role requires a strong understanding of health authority regulations, ensure you mention any relevant certifications or training. Discuss your familiarity with Good Practices (GxP) and how you've applied them in past positions.
Showcase Teamwork and Communication Skills: The job emphasises collaboration across departments. Provide examples in your application that demonstrate your ability to work effectively in teams, communicate clearly, and lead initiatives that require cross-functional cooperation.
How to prepare for a job interview at GE Healthcare
✨Understand the Role Thoroughly
Before the interview, make sure you have a solid grasp of the R&D Compliance Leader role. Familiarise yourself with the key responsibilities such as process development, regulatory compliance, and quality enhancement. This will help you articulate how your experience aligns with their needs.
✨Showcase Your Regulatory Knowledge
Given the importance of regulatory compliance in this role, be prepared to discuss your understanding of relevant Health Authority regulations and the drug development process. Share specific examples from your past experiences where you successfully navigated compliance challenges.
✨Demonstrate Problem-Solving Skills
The ability to identify and resolve compliance issues is crucial. Prepare to discuss instances where you've proactively identified problems and implemented effective solutions. Highlight your analytical skills and your approach to continuous process improvement.
✨Emphasise Teamwork and Communication
This role requires strong teamwork and interpersonal skills. Be ready to provide examples of how you've collaborated with cross-functional teams in the past. Discuss how you communicate complex information clearly and effectively to ensure everyone is on the same page.
