Instagram
youtube
Facebook

Clinical Transparency Lead

6-10 years
Not Disclosed
10 Dec. 19, 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

Job Title: Regulatory Process Manager
Location: Bengaluru Luxor North Tower, Bangalore
Posted Date: Dec 11, 2024

About GSK:
GSK is a global biopharma company committed to uniting science, technology, and talent to get ahead of disease together. We focus on four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology. Our mission is to positively impact the health of billions of people and deliver stronger, sustainable shareholder returns. At GSK, we place great value on our people, encouraging an environment where they can thrive, grow, and feel supported.

Role Overview:
As a Regulatory Process Manager, you will be an active contributor to cross-functional and global projects that impact regulatory processes. You will collaborate closely with internal and external stakeholders, including System Support and IT teams, to address system issues, upgrades, and ensure minimal disruption to the users. You will also maintain process documentation and training materials, ensure compliance, and support the training of staff involved in regulatory activities.

Key Responsibilities:

  • Contribute to global projects impacting regulatory processes and ensure GSK’s active participation in external discussions on regulatory changes.
  • Build strong relationships with key business stakeholders responsible for regulatory document delivery.
  • Work with IT teams to address system issues, upgrades, and bugs in a timely manner.
  • Maintain relevant process documentation and training materials.
  • Ensure that all staff contributing to regulatory processes receive appropriate training.
  • Participate in internal and external audits related to regulatory processes and respond to findings.
  • Develop and maintain reports and alerts to monitor compliance with quality standards and timelines.
  • Collaborate with external partners and ensure they are trained and compliant with required policies.

Qualifications & Experience:

  • Basic Qualifications:
    • Bachelor’s degree in Life Sciences or a related discipline; Postgraduate degree preferred.
    • A minimum of 6 years of clinical development experience.
  • Job-Related Experience:
    • Strong understanding of R&D and clinical development processes.
    • Excellent negotiation and influencing skills.
    • Ability to work independently and manage conflicting demands in a fast-paced, high-pressure environment.
    • Excellent verbal and written communication skills.
    • Knowledge of GSK systems impacting regulatory processes.
    • Experience in regulatory requirements is an advantage.
    • Experience interacting with senior managers within GSK.

Preferred Qualifications:

  • Proven experience in managing learning projects related to physician/scientific development and training.
  • Ability to coordinate projects involving diverse stakeholders from various geographic locations.
  • Strong communication and organizational skills.

Why GSK?
GSK values its employees and encourages a culture of innovation, teamwork, and respect. We provide opportunities for personal and professional growth, ensuring that our people thrive in their careers. At GSK, we embrace diversity, equity, inclusion, and belonging, making it a place where everyone can be confident in their health and healthcare.

Important Notice:
GSK does not accept unsolicited resumes from employment businesses/agencies. Unauthorized referrals will not be liable for any fees.