At a Glance
- Tasks: Support study quality and compliance in toxicology, ensuring regulatory adherence and data management.
- Company: Join Novartis, a leader in pharmaceutical innovation with a commitment to excellence.
- Benefits: Competitive salary, comprehensive health benefits, 401(k) match, and generous time off.
- Other info: Flexible hybrid work model and opportunities for professional growth.
- Why this job: Make a real impact in nonclinical safety while advancing your career in a dynamic environment.
- Qualifications: Degree in biological sciences and 8+ years of experience in a GLP setting.
The predicted salary is between 119700 - 222300 £ per year.
The individual will provide scientific and operational support to the Study Quality and Compliance group within the Toxicology line function of Preclinical Safety (PCS). Key areas of responsibility or oversight include ensuring training records, CVs, Job Descriptions (JDs) for all of PCS are appropriately maintained and on file, as well as periodic review and maintenance of departmental SOPs. With respect to these items, provide support to health authority inspections and internal inspection-readiness audits. This person will also be responsible for coordinating with the Archive Records Management function for the transfer of GLP and non-GLP study records and materials from one archive location to another. The ideal candidate would also have experience with SEND (Standard for Exchange of Nonclinical Data) packages to provide support for both creation and QC of these datasets.
Key Responsibilities:
- Oversee periodic review and maintenance of PCS SOPs, garnering necessary stakeholder input and having good working knowledge of any company SOPs that influence or impact the PCS SOPs.
- Be responsible for ensuring PCS compliance with training records CV, and JDs, and ensure the process for doing so is consistent with GLP requirements.
- Support Archives Record Management (ARM) function, by collating a listing of all studies that have records and materials archived at CRO study site. Coordinate the ARM transfers to permanent archiving locations.
- Support SEND package creation and quality review for FDA submissions.
- Support the Study Quality and Compliance team’s effort for tracking and managing study-related information through input of information types from the areas of responsibility above and generally support the effort in various workstreams or initiatives.
Essential Requirements:
- Degree in biological related sciences.
- 8+ years of relevant experience working in a pharmaceutical setting.
- Experience working in GLP setting, and general regulatory compliance and animal welfare knowledge related to conduct of toxicology studies.
- Good communication skills, and excellent logistical/planning skills.
- Fluent in English (spoken and written).
Desirable Requirements:
- Previous experience with SEND packages is desirable.
- Previous experience with software for online information and program management is a plus.
This is a dual level posting. The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered.
The salary for this position is expected to range between:
- Principal Scientist I: $119,700 and $222,300 per year.
- Principal Scientist II: $126,000 and $234,000 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Principal Scientist I/II, Study Quality and Compliance - Nonclinical Safety/Toxicology in Cambridge employer: Novartis
At Novartis, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our hybrid work model allows for flexibility while providing ample opportunities for professional growth and development in the pharmaceutical industry. With a commitment to enhancing customer experiences for healthcare professionals and patients alike, joining our team means contributing to meaningful work that makes a difference in people's lives.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Scientist I/II, Study Quality and Compliance - Nonclinical Safety/Toxicology in Cambridge
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We think you need these skills to ace Principal Scientist I/II, Study Quality and Compliance - Nonclinical Safety/Toxicology in Cambridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Novartis!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Novartis that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Novartis!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Novartis, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Novartis
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Novartis that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Novartis’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
