About the role

Aplyr's Quick Take

This role is focused on ensuring compliance and quality in preclinical safety studies within a pharmaceutical setting. You'll manage documentation, support regulatory submissions, and maintain SOPs while collaborating with various stakeholders. It's primarily an individual contributor role with a strong emphasis on operational support and compliance.

Good fit

Ideal candidates have 10-15 years of experience in a GLP environment, particularly in toxicology or related fields. Strong communication and organizational skills are essential, along with a solid understanding of regulatory compliance.

Worth noting

The role emphasizes maintaining compliance and quality standards, which may appeal to those who enjoy detail-oriented work. However, the position is office-based in Hyderabad, which could be a consideration for remote work preferences.

Job Description Summary

This role will provide scientific and operational support to Study Quality and Compliance group within PreClinical Safety (PCS) function.

Job Description

Major Accountabilities:

Ensuring PCS compliance with training records, CV, and JDs.
Ensure all documentation is consistent with GLP requirements.
Support periodic review and maintenance of PCS SOPs.
Maintain good working knowledge of any company SOPs that influence or impact the PCS SOPs.
Get necessary input/feedback from relevant stakeholders to keep documentations up-to-date·
Create and perform quality checks on SEND packages for FDA submissions
Support electronic laboratory notebook compliance ensuring the necessary reviews and compliance with company guidelines
Support the Study Quality and Compliance team’s effort for tracking and managing study-related information in a global online fashion by leveraging the use of software tools to enhance productivity and information sharing.

Minimum Requirements:

Graduate/ Postgraduate in Life Sciences with 10-15 years relevant experience working in pharmaceutical GLP setting.
Good working knowledge of regulatory compliance requirements
Knowledge of animal welfare requirements related to study conduct

Previous experience creating and reviewing SEND packages
Good communication skills, and excellent logistical/planning skills
Previous experience with software for online information and program management is a plus

Skills Desired

Animal Models, Bioinformatics, Collaboration, Communication Skills (Inactive), Data Analysis, Ethics, Laboratory (Inactive), Problem Solving, Regulatory Compliance, Researching, Risk Assessments, Toxicology

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.