At a Glance
- Tasks: Manage distribution configurations and ensure compliance with global safety regulations.
- Company: Join a leading global organisation focused on safety and compliance.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Dynamic team environment with a focus on continuous improvement and innovation.
- Why this job: Be at the forefront of regulatory compliance and make a real difference in safety.
- Qualifications: Degree or relevant experience; understanding of regulatory reporting is a plus.
The predicted salary is between 40000 - 50000 £ per year.
All Job Posting Locations: Bangalore, Karnataka, India; High Wycombe, Buckinghamshire, United Kingdom; Horsham, Pennsylvania, United States of America; Hyderabad, Andhra Pradesh, India; Raritan, New Jersey, United States of America; Titusville, New Jersey, United States of America.
Essential Job Duties And Responsibilities
- Performs Distribution Anchor (DA) related activities.
- Leads interactions with Local Safety Officers to gather regulatory intelligence to support Distribution rule implementation and maintenance.
- Documents local country regulatory requirements and interprets requirements into Distribution Anchors technical requirements.
- Creates Distribution Anchors directly into the Global Safety system.
- Manages daily workload and ensures Distribution rule related tasks are completed timely as allocated to ensure completion of daily activities.
- Performs Quality Control activities of individual and team related work.
- Performs informal Testing of new/modified Distribution Anchors as required.
- Close liaison with Distribution Configuration Management team regarding workload management.
- Deputises for Manager/Director as identified.
- Contributes in team meetings and performs daily liaison with team members to identify and resolve processing issues.
- Drives the creation and continuous improvement of consistent processes that meet both internal and regulatory standards to ensure global compliance.
- Develops Metrics to monitor key performance indicators across key Distribution Configuration Management areas.
- Assists Manager with implementation of processes, and issue management.
Operational Activities
- Identifies and resolves issues or prepares documentation and options for solution where escalation is required.
- Is responsible for impact assessments and bolus management activities relating to DAs.
Liaison with stakeholders and 3rd parties
- Provide support to clarify procedures (e.g., training) to ensure compliance relating to collaboration with business partners, European Medicines Agency (EMA), Food and Drug Administration (FDA) and other Global Regulatory Authorities (RAs), Local Safety Officers (LSOs), Pharmacovigilance (PV) nominated persons, and other groups such as Global Clinical Operations (GCO), licensing partners and Regulatory Affairs (RA).
- Assist with Service Level Agreements (SLAs) between GMSO and Marketing Authorization Holders (MAHs), and/or Pharmacovigilance Agreements (PVAs).
- In particular, the oversight of the DAs within the Global Safety system.
- Liaise with other functional areas to facilitate resolution of queries and issues.
Projects and Initiatives
- Acts as Subject Matter Expert (SME) when requested in one or more of the below activities:
- Regulatory Reporting intelligence
- Quality monitoring activities
- Process/system improvement
- Compliance and quality metrics preparation
- Controlled document creation/update
- Quality Investigations and CAPA activities
- Identifies and develops solutions for areas needing improvement and considers the use of technology for the automation of process steps.
Quality and Compliance
- Develops / updates Standard Operating Procedures (SOPs) and other controlled documents relevant for the coordination of tasks, business continuity and audit/inspection readiness.
- Represents Distribution Configuration Management in audits and inspections when requested and provides support for document requests.
- Investigate, document and track compliance related data and identify any trends.
Other
- Maintain knowledge on worldwide regulations/guidance related to Individual Case Safety Report (ICSR) case processing and reporting activities.
Minimum Qualification Education
- Degree and/or relevant work experience, advanced degree is preferred.
Required Experience
- Developed Understanding of US and EU electronic regulatory reporting requirements for ICSPR.
- Accumulated expertise in pharmacovigilance operations related activities including single case processing, database queries, expedited reporting.
- Knowledge of regional and global safety regulations.
- Good understanding of technologies, systems and databases related to E2B electronic reporting.
- Highly reliable, and compliant with legal and company guidelines.
- Excellent organizational and communication skills including presentation abilities.
- Ability to produce high quality work under time critical and high-pressure situations.
- Project Management Skills desirable.
Distribution Configuration Management Analyst in High Wycombe employer: Johnson & Johnson Innovative Medicine
As a Distribution Configuration Management Analyst, you will thrive in a dynamic and supportive work environment that prioritises employee growth and development. Our company fosters a culture of collaboration and innovation, offering comprehensive training programs and opportunities for career advancement, all while being located in vibrant cities like Bangalore and High Wycombe. Join us to be part of a team that values compliance, quality, and continuous improvement, ensuring that your contributions make a meaningful impact in the regulatory landscape.
Contact Details:
Johnson & Johnson Innovative Medicine Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Distribution Configuration Management Analyst in High Wycombe
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work in distribution or regulatory roles. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their approach to compliance and safety regulations. This will help you tailor your answers and show them you're the perfect fit for their team.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your responses. Focus on how your skills align with the responsibilities of a Distribution Configuration Management Analyst.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Distribution Configuration Management Analyst in High Wycombe
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Distribution Configuration Management Analyst role. Highlight relevant experience and skills that match the job description, especially in regulatory reporting and compliance.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this position. Share specific examples of your past work that relate to the responsibilities listed in the job description, like managing daily workloads or liaising with stakeholders.
Showcase Your Communication Skills:Since this role involves a lot of interaction with various teams and stakeholders, make sure to demonstrate your excellent communication skills in your application. Use clear and concise language to convey your points.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss any important updates from us!
How to prepare for a job interview at Johnson & Johnson Innovative Medicine
✨Know Your Regulations
Make sure you brush up on the US and EU electronic regulatory reporting requirements for ICSR case processing. Being able to discuss these in detail will show that you understand the core responsibilities of a Distribution Configuration Management Analyst.
✨Showcase Your Quality Control Skills
Prepare examples of how you've performed quality control activities in previous roles. Highlight any specific metrics you've developed or improvements you've implemented, as this will demonstrate your ability to contribute to compliance and quality metrics preparation.
✨Be Ready to Discuss Process Improvements
Think about instances where you've identified areas needing improvement in processes. Be prepared to share how you approached these challenges and any technology solutions you considered for automation, as this aligns with the job's focus on continuous improvement.
✨Communicate Effectively
Since the role involves liaising with various stakeholders, practice articulating your thoughts clearly and concisely. Prepare to discuss how you've successfully communicated complex information in the past, especially in high-pressure situations, to showcase your organisational and communication skills.
