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- Tasks: Join our team to prepare and publish clinical documents for global regulatory submissions.
- Company: Novartis is a leading pharmaceutical company focused on improving lives through innovative medicine.
- Benefits: Enjoy hybrid work, competitive rewards, and a commitment to diversity and inclusion.
- Why this job: Be part of a mission-driven team that reimagines medicine and impacts patients' lives globally.
- Qualifications: Bachelor's in life sciences, experience in clinical document publishing, and strong project management skills required.
- Other info: Work in a collaborative environment with opportunities for continuous improvement and technology implementation.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Summary Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets & enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers. About the Role
This role offers hybrid working, requiring 3 days per week in person in our White City, London office. Ad-hoc working hours to overlap the US as required.
Major accountabilities:
- Manages medium to small level global regulatory submission projects.
- Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
- Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
- Frequent internal company and external contacts.
- Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Minimum Requirements:
- Bachelor's degree in life sciences or relevant discipline.
- Fluency in English
- Clinical Report and Global Submission dossier publishing/compilation experience in the pharmaceutical or related industry.
- Experience with electronic clinical document publishing standards/formats, electronic and global regulatory submission publishing standards/formats (e.g. eCTD, EU CTR).
- Working knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tools
- Familiarity with global Clinical and Regulatory HA requirements (e.g., FDA, ICH, EMA, MENA region, CH, MHRA)
- Strong interpersonal and project management skills, and experience working in a complex, global cross functional organization.
- Highly motivated, organized, and detailed oriented team player
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
#LI-DNI
Global Regulatory Publishing Associate employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Regulatory Publishing Associate
✨Tip Number 1
Familiarize yourself with the specific electronic publishing standards and formats mentioned in the job description, such as eCTD and EU CTR. This knowledge will not only help you understand the role better but also demonstrate your commitment to the position during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who work in regulatory operations. Engaging with them on platforms like LinkedIn can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in global regulatory requirements by following relevant industry news and publications. This will show your proactive approach and readiness to adapt to evolving standards.
✨Tip Number 4
Prepare to discuss your experience with cross-functional collaboration during interviews. Highlight specific examples where you've successfully worked with diverse teams, as this is a key aspect of the role.
We think you need these skills to ace Global Regulatory Publishing Associate
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Global Regulatory Publishing Associate position. Highlight key responsibilities and requirements that resonate with your experience.
Tailor Your CV: Customize your CV to reflect relevant experiences in clinical document publishing and regulatory submissions. Use specific examples that demonstrate your familiarity with eCTD and other publishing standards.
Craft a Compelling Cover Letter: Write a cover letter that connects your background in life sciences and project management to the role. Emphasize your motivation to contribute to Novartis' mission of improving patients' lives.
Highlight Interpersonal Skills: In your application, showcase your strong interpersonal skills and ability to work in cross-functional teams. Provide examples of how you've successfully collaborated with diverse stakeholders in previous roles.
How to prepare for a job interview at Novartis
✨Understand Regulatory Standards
Familiarize yourself with the electronic clinical document publishing standards and global regulatory submission formats like eCTD and EU CTR. Being able to discuss these in detail will show your expertise and readiness for the role.
✨Showcase Your Technical Skills
Be prepared to talk about your experience with publishing tools such as DXC, eCTD Xpress, and Veeva. Highlight specific projects where you utilized these tools to demonstrate your hands-on experience.
✨Emphasize Collaboration Experience
Since this role involves working with cross-functional teams, share examples of how you've successfully collaborated with various stakeholders in previous roles. This will illustrate your interpersonal skills and ability to work in a complex environment.
✨Demonstrate Problem-Solving Abilities
Prepare to discuss situations where you faced challenges in project management or regulatory submissions and how you overcame them. This will showcase your analytical thinking and adaptability, which are crucial for this position.
