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Lifescience Regulatory Svs Associate

1-3 years
Not Disclosed
15 June 10, 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, 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

Skill Required:

  • Regulatory Operations - Life Sciences Regulatory Operations

Designation:

  • LifeScience Regulatory Svs Associate

Qualifications:

  • Bachelor of Pharmacy/Master of Pharmacy

Years of Experience:

  • 1 to 3 years

Language Ability:

  • English - Expert

About Accenture:

Accenture is a global professional services company with leading capabilities in digital, cloud, and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song—all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners, and communities. Visit us at www.accenture.com.

What Would You Do?

You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.

The incumbent will perform regulatory operations tasks such as bookmarking and hyperlinking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, reviewing and transforming source documents. Perform Quality Control (Document QC) checks for all submission components. You will be expected to coordinate the essential documentation and resources required for the filing of global applications. Understand, manage, and process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc.

What Are We Looking For?

  • Negotiation skills
  • Problem-solving skills
  • Strong analytical skills
  • Commitment to quality
  • Ability to perform under pressure
  • Life Sciences knowledge

Roles and Responsibilities:

  • Solve routine problems largely through precedent and referral to general guidelines.
  • Interact primarily within your own team and direct supervisor.
  • Receive detailed to moderate instruction on daily work tasks and detailed instruction on new assignments.
  • Your decisions will impact your own work.
  • You will be an individual contributor as part of a team with a predetermined, focused scope of work.
  • Please note that this role may require you to work in rotational shifts.