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For Companies At a Glance
- Tasks: Lead clinical compliance and processes, ensuring adherence to quality standards and regulations.
- Company: Join Novartis, a leader in healthcare innovation and patient care.
- Benefits: Hybrid working, competitive salary, and opportunities for personal and professional growth.
- Why this job: Make a real impact on clinical trials and improve patient lives through innovative practices.
- Qualifications: Advanced degree in life sciences and 5+ years in the pharma industry required.
- Other info: Be part of a diverse team committed to collaboration and creativity.
The predicted salary is between 72000 - 108000 £ per year.
LOCATION: Dublin, London
ROLE TYPE: Hybrid Working
The Associate Director Clinical Compliance and Processes, in close collaboration with the Head Clinical Compliance & Processes, ensures that Clinical Development (CD) across Development Units (DU) operates according to Novartis quality standards and in line with Health Authority regulations. Guides CD Process SMEs in the development and implementation of cross-functional processes. Assists the Head Clinical Compliance & Processes in supporting clinical associates as part of Clinical Trial Teams (CTT) for audits and Health Authority inspections and supports the coordination of inspections for CD.
Major accountabilities
- Represents CD at the Global Process and Governance Board (GPGB) reviewing change requests, endorsing SOP, WP, ATTs and ensuring CD subject matter experts (SMEs) are adequately involved in process reviews and updates.
- Maintain SME database for CD.
- Function as GCP SME where needed and coach the community of CD SMEs in process simplification in alignment with regulations.
- Defines the applicability of GxP training, develops adequate curriculums and oversees training compliance for CD roles.
- Assists Head Clinical Compliance & Processes in overseeing the development & completion of Corrective Actions & Preventive Actions (CAPA), Quality Issues (QI), and driving the continuous assessment of CD quality and compliance risks; proposes and eventually leads corrective, preventive or improvement activities.
- Oversee QIs of CD in collaboration with Global Clinical Operations Compliance Manager to perform investigation and root cause analysis.
- Supports Head Clinical Compliance & Processes for inspection readiness of CTTs and provides support & guidance for on-time delivery of Health Authority pre-requests, responses during/after inspections and closing actions.
- Ensures that CD process SMEs have prepared aligned process storyboards, CD associates are trained to explain process evolution from study start to end and documents are up to date to support CD members for inspections.
- May deputize for Head Clinical Compliance & Processes in representing CD in the Inspection Center of Excellence and Inspection Compliance Committee as business lead contributing to the improvement of inspection-related processes, quality, and compliance across functions and units.
- Represent CD in routine Inspection calls and in inspection related discussions.
- As agreed with Head Business Solutions, represents CS & CD in cross-functional initiatives in Development.
- Oversee Risk-Based Quality Management activities for CD.
- In collaboration with quality system owners, process owners and CD Process SMEs, supports assessment of new regulations on clinical processes and oversight of required changes; supports review of draft Health Authority guidance.
- Supports Head Clinical Compliance & Processes, Process Owners and CD Process SMEs with integration of Quality Management System for BD&L and Merge & Acquisitions.
- Helps to drive a curious, inspired, and unbossed culture within and outside of CS & CD and is seen as a role model of collaboration for joint success.
Education
Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master, PharmD, or PhD strongly preferred.
Experience
- ≥5 year experience in life sciences/ healthcare/pharma industry
- Experience in clinical trial leadership is a plus
- Thorough knowledge of Good Clinical Practice, regulations, and Quality Management Systems
- Experienced in designing effective and efficient end-to-end processes across functions and units
- Excellent analytical and data driven mind-set
- Action orientated mindset: make things happen
- Strong skills in leading and managing cross-functional projects/teams with significant (visible) business impact
- Demonstrated courage to assume personal accountability in challenging situations
- Needs to be able to work independently
- Excellent interpersonal and communication skills
- Excellent influencing, negotiation and conflict resolution skills
- Expertise in organization dynamics
- Act as change agent and actively generate and foster creativity and innovation in CD
- Strong project management skills
- Leadership presence with the ability to present and interact with senior management.
Commitment To Diversity And Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Visit: https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards
Learn about all the ways we’ll help you thrive personally and professionally.
Associate Director Clinical Compliance & Processes employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Clinical Compliance & Processes
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and role thoroughly. Understand their values and how your experience aligns with their needs. This will help you stand out and show that you're genuinely interested.
✨Tip Number 3
Practice your interview skills with friends or family. Get comfortable talking about your experiences and how they relate to the job. The more you practice, the more confident you'll feel when it’s time to shine.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression and shows your enthusiasm for the role. Plus, it keeps you on their radar as they make their decision.
We think you need these skills to ace Associate Director Clinical Compliance & Processes
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your relevant experience in clinical compliance and processes. We want to see how your background aligns with the role, so don’t hold back on showcasing your skills!
Showcase Your Experience: When detailing your work history, focus on your achievements in the life sciences or pharma industry. We love seeing examples of how you've led projects or improved processes, so be specific about your contributions.
Be Clear and Concise: Keep your application straightforward and to the point. Use clear language and avoid jargon where possible. We appreciate a well-structured application that’s easy to read and understand.
Apply Through Our Website: Don’t forget to submit your application through our official website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Novartis
✨Know Your Regulations
Make sure you brush up on Good Clinical Practice and relevant regulations before the interview. Being able to discuss how these apply to clinical compliance will show that you’re not just familiar with the theory, but also understand its practical implications.
✨Showcase Your Leadership Skills
Prepare examples of how you've led cross-functional projects or teams in the past. Highlight your ability to influence and negotiate effectively, as this role requires strong interpersonal skills and the courage to take accountability in challenging situations.
✨Demonstrate Analytical Thinking
Be ready to discuss how you've used data to drive decisions in previous roles. This could involve explaining a situation where your analytical mindset helped identify a compliance risk or improved a process. It’s all about showing that you can think critically and act decisively.
✨Emphasise Continuous Improvement
Talk about your experience with CAPA and quality management systems. Share specific instances where you’ve contributed to process simplification or improvement initiatives. This will demonstrate your commitment to driving a curious and innovative culture within clinical development.