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Lifescience Regulatory Svs Associate

1-3 years
Not Disclosed
10 Aug. 22, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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 Description

Role: Life Science Regulatory Services Associate
Skill Required: Regulatory Services - Life Sciences Regulatory Operations
Qualifications: Any Graduation
Experience: 1 to 3 years
Language Requirement: Intermediate Spanish

About Accenture:
Accenture is a global leader in professional services, offering unmatched expertise in digital, cloud, and security across more than 40 industries. We provide comprehensive Strategy and Consulting, Technology and Operations services, and Accenture Song, all supported by our extensive network of Advanced Technology and Intelligent Operations centers. With 699,000 professionals serving clients in over 120 countries, we drive innovation and create value through technology and human ingenuity. For more information, visit www.accenture.com.

Role Overview:
As a Life Science Regulatory Services Associate, you will be an integral part of our Life Sciences R&D team, providing essential regulatory support across the entire life sciences spectrum. Your role will focus on managing regulatory operations tasks including bookmarking, hyperlinking submission documents, and performing quality control checks. You will also coordinate documentation and resources for global submissions and manage electronic filings for various types of regulatory applications.

Key Responsibilities:

  • Regulatory Operations: Perform bookmarking and hyperlinking of submission documents in line with ICH guidelines and other Health Authority requirements.
  • Document Management: Review and transform source documents, and conduct quality control checks on all submission components.
  • Submission Coordination: Manage and process electronic submissions, including original application filings, Life Cycle Management submissions (CMC, Ad-promos, amendments, annual reports, SPL submissions), and more.
  • Documentation Support: Coordinate essential documentation and resources necessary for global application filings.
  • Problem-Solving: Address routine problems using established guidelines and seek guidance from your supervisor when needed.
  • Team Interaction: Work closely with your team and supervisor to handle daily tasks and new assignments.

Qualifications:

  • Education: Any Graduation.
  • Experience: 1 to 3 years in a related role.
  • Language: Intermediate proficiency in Spanish.
  • Skills: Strong attention to detail, ability to manage electronic submissions, and proficiency in document management.

Additional Information:

  • Work Environment: This role may require working in rotational shifts.
  • Individual Contributor: Operate as a key team member with a focused scope of work, making decisions that impact your responsibilities.

Join Accenture to be part of a forward-thinking team that drives success through innovation and excellence. Apply now to help shape the future of life sciences regulatory operations.