Instagram
youtube
Facebook

Associate Manager- Rim

2-3 years
Not Disclosed
10 Oct. 9, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary

This role involves coordinating and preparing for internal and external audits and ensuring compliance with regulatory standards. You will collaborate with clients to foster proactive regulatory compliance strategies, ensure adherence to privacy and security standards, and assist in interactions during regulatory agency inspections. Additionally, you may engage directly with regulatory agencies on specific matters and recommend strategies to expedite clinical trial application approvals. You will also support the implementation of corrective actions and coordinate audits of investigator sites and clinical supplier vendors.

About the Role

Major Accountabilities:

  • Ensure high data quality within Regulatory Information Management (RIM) systems by monitoring data accuracy and completeness, with guidance.
  • Proactively follow up with stakeholders (e.g., Country Organizations, RA CMC, HQ RA Managers) to ensure timely updates and maintenance of data in RIM systems.
  • Collaborate with the RIM team to implement new cleaning rules and develop corresponding training materials.
  • Promote a culture of compliance and quality within Regulatory Affairs (RA) through effective teamwork and open communication.
  • Escalate potential compliance risks to management as needed.
  • Support the implementation of RA systems in collaboration with subject matter experts and IT teams.
  • Compile regulatory compliance monitoring reports and follow up on quality issues.
  • Manage deviations, incidents, Quality Events, and Corrective and Preventive Actions (CAPAs) in the relevant systems in accordance with established timelines.
  • Assist or lead the preparation of RA for assigned internal global audits.

Key Performance Indicators:

  • Maintain a fully compliant portfolio with internal and external regulations and procedures.
  • Adherence to Novartis policies and guidelines.
  • Positive feedback from stakeholders and project teams.

Minimum Requirements

Work Experience:

  • Cross-cultural experience.
  • Operations management and execution.
  • Ability to collaborate across boundaries.

Skills:

  • A scientific degree in life sciences or a related field.
  • At least 2-3 years of professional experience in Regulatory Affairs in the pharmaceutical industry or a related area.
  • Strong proficiency in Microsoft Office Suite (Excel, PowerPoint, SharePoint, OneNote, MS Teams, etc.).
  • Basic understanding of the drug development process and regulatory compliance for marketed products and investigational trials.
  • Ability to quickly learn and utilize RA systems.
  • Strong interpersonal and communication skills, both verbal and written.
  • Good analytical skills with the ability to generate meaningful reports from RA systems.
  • Precise and independent working style with a strong sense of responsibility and initiative.
  • Logical and methodical approach with attention to detail.

Languages:

  • Proficient in English.

Why Novartis

Helping individuals with diseases and their families requires more than just innovative science; it takes a community of passionate and skilled professionals like you. By collaborating, supporting, and inspiring one another, we can achieve breakthroughs that transform patients’ lives. Ready to create a brighter future together? Learn more about our strategy and culture here.

Join Our Novartis Network

If this role isn't the right fit for you, sign up for our talent community to stay connected and receive updates about suitable career opportunities as they arise: Join the Novartis Network.

Benefits and Rewards

Discover how we support your personal and professional growth in our benefits handbook.

Division

  • Development

Business Unit

  • Innovative Medicines

Location

  • Hyderabad, India (Office)

Company / Legal Entity

  • IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

  • Research & Development

Job Type

  • Full Time

Employment Type

  • Regular

Shift Work

  • No

Accessibility and Accommodation

Novartis is committed to providing reasonable accommodations for individuals with disabilities. If you require assistance due to a medical condition or disability during the recruitment process or to perform essential job functions, please contact us at diversityandincl.india@novartis.com, including the job requisition number in your message.

Novartis is dedicated to creating an inclusive work environment and building diverse teams that reflect the patients and communities we serve.