JOB DESCRIPTION: HEALTH OPERATIONS NEW ASSOCIATE
COMPANY: Accenture
JOB TITLE: Health Operations New Associate
JOB CATEGORY: Healthcare Operations / Life Sciences Regulatory Operations
JOB NUMBER: AIOC-S01674577
JOB LOCATION: Chennai, Tamil Nadu, India
EMPLOYMENT TYPE: Full Time
EXPERIENCE: 0–1 Years (as mentioned in the job overview)
QUALIFICATION: Any Graduation
PRIMARY SKILL: Membership – Life Sciences Regulatory Operations
SKILL LEVEL: P3
1. ABOUT THE COMPANY – ACCENTURE
Accenture is a global professional services company providing solutions across technology, consulting, digital transformation, cloud, security and business operations.
The organisation works across more than 40 industries and serves clients in over 120 countries.
Accenture focuses on combining technology and human expertise to deliver innovative solutions and improve business operations.
Its major business areas include:
Strategy and Consulting.
Technology Services.
Operations.
Digital Transformation.
Cloud and Security.
Intelligent Operations.
Healthcare and Life Sciences.
2. ABOUT THE ROLE
The Health Operations New Associate role is part of Accenture's Healthcare Operations team, with a primary focus on Life Sciences Regulatory Operations.
The role involves supporting regulatory documentation, managing electronic submissions and coordinating essential resources required for global pharmaceutical regulatory applications.
The selected candidate will support the preparation, processing and management of regulatory submissions, including original application filings and Life Cycle Management (LCM) submissions.
This position provides an opportunity for entry-level candidates to develop knowledge of pharmaceutical regulatory operations, electronic submissions and healthcare administration.
3. EDUCATIONAL QUALIFICATIONS
Any graduation is accepted.
A degree in Life Sciences, Pharmacy or a relevant healthcare discipline may be beneficial for understanding pharmaceutical regulatory documentation.
4. EXPERIENCE REQUIREMENTS
The job posting mentions the following experience requirements:
Job overview: 0–1 years.
Job title summary: 0–2 years.
Detailed role description: 1–3 years of experience in healthcare appeals, claims processing, medical billing or a similar role within a health insurance company.
Candidates should confirm the applicable experience requirement with the recruitment team.
5. PRIMARY SKILL – LIFE SCIENCES REGULATORY OPERATIONS
The primary skill required for this position is Life Sciences Regulatory Operations.
This involves supporting pharmaceutical companies in managing regulatory documentation and electronic submissions required for drug approvals and lifecycle maintenance.
Important areas include:
Pharmaceutical regulatory documentation.
Global regulatory submissions.
Original application filings.
Electronic submission management.
Life Cycle Management (LCM).
Chemistry, Manufacturing and Controls (CMC) submissions.
Advertising and Promotional (Ad-Promos) submissions.
Regulatory amendments.
Annual reports.
Structured Product Labeling (SPL) submissions.
6. KEY ROLES AND RESPONSIBILITIES
A. REGULATORY DOCUMENTATION MANAGEMENT
Coordinate essential documentation required for global regulatory applications.
Collect and organise regulatory documents.
Ensure documentation is complete and accurate.
Maintain regulatory submission records.
Coordinate with relevant teams for missing documents.
Support timely preparation of regulatory application packages.
Follow established documentation procedures.
B. ELECTRONIC REGULATORY SUBMISSION MANAGEMENT
Understand and manage electronic regulatory submissions.
Process original application filings.
Support electronic submission activities.
Maintain submission-related documentation.
Follow established submission workflows.
Ensure accurate processing of regulatory application information.
Coordinate with relevant stakeholders during submission activities.
C. LIFE CYCLE MANAGEMENT (LCM) SUBMISSIONS
Support the processing of different types of pharmaceutical regulatory lifecycle submissions, including:
CMC submissions.
Advertising and Promotional (Ad-Promo) submissions.
Regulatory amendments.
Annual reports.
Structured Product Labeling (SPL) submissions.
Other relevant lifecycle regulatory submissions.
D. REGULATORY OPERATIONS SUPPORT
Support daily regulatory operations.
Follow predefined regulatory processes and guidelines.
Perform assigned documentation and submission activities.
Identify routine processing issues.
Escalate complex issues to supervisors.
Maintain accuracy and quality in assigned tasks.
Complete activities within established timelines.
E. HEALTHCARE OPERATIONS SUPPORT
The role is associated with the Healthcare Management team, which supports the administration and operational activities of healthcare organisations.
Relevant healthcare operations may include:
Hospital administration.
Outpatient clinic administration.
Hospice operations.
Medical and health services administration.
Departmental activities.
Healthcare budgeting and related administration.
Research and education support.
Quality assurance.
Patient services.
Healthcare policies and procedures.
Public relations.
7. REQUIRED TECHNICAL AND FUNCTIONAL KNOWLEDGE
Candidates should develop an understanding of:
Life Sciences Regulatory Operations.
Pharmaceutical regulatory documentation.
Global regulatory applications.
Electronic regulatory submissions.
Original application filings.
Regulatory lifecycle management.
CMC submissions.
Ad-Promo submissions.
Regulatory amendments.
Annual reports.
SPL submissions.
Healthcare operations.
Documentation management.
Quality assurance.
8. REQUIRED SKILLS AND COMPETENCIES
Basic understanding of healthcare and life sciences.
Good documentation and record-management skills.
Attention to detail.
Ability to follow standard operating procedures.
Good written and verbal communication.
Basic computer knowledge.
Ability to manage routine operational activities.
Time management and prioritisation.
Team collaboration.
Problem identification and escalation.
Ability to work in rotational shifts.
Willingness to learn regulatory processes.
9. ROLE LEVEL AND WORK RESPONSIBILITIES
This is an entry-level individual contributor position.
The job description indicates the following expectations:
Solve routine problems using established procedures.
Refer to standard guidelines when handling assigned tasks.
Work primarily within the immediate team.
Report to a direct supervisor.
Follow detailed instructions for assigned activities.
Make decisions that primarily affect individual work.
Work within a predefined and limited scope of responsibilities.
Escalate issues that require additional guidance.
10. WORKING HOURS AND WORKING MODEL
SHIFT TIMINGS
9:00 PM to 6:00 AM IST.
Shift aligned with the US Pacific Standard Time (PST) time zone.
Working hours may shift by one hour during daylight saving time.
Rotational shifts may be required.
WORK FROM OFFICE (RTO) POLICY
100% Work From Office (WFO) for the first six months.
Hybrid working may be offered after six months, depending on performance and company requirements.
JOB LOCATION
Chennai, Tamil Nadu, India.
11. IMPORTANT REGULATORY TERMINOLOGIES
A. CMC – CHEMISTRY, MANUFACTURING AND CONTROLS
CMC refers to the regulatory information concerning the manufacturing process, quality, composition, specifications and controls of pharmaceutical products.
It helps demonstrate that a medicine is consistently manufactured according to required quality standards.
B. AD-PROMO – ADVERTISING AND PROMOTIONAL SUBMISSIONS
These submissions involve regulatory documentation related to pharmaceutical product advertising and promotional materials.
They support compliance with applicable promotional and regulatory requirements.
C. AMENDMENTS
Regulatory amendments are updates or changes submitted to regulatory authorities regarding previously approved or submitted applications.
D. ANNUAL REPORTS
Annual reports provide updates on relevant regulatory information and changes associated with approved pharmaceutical products, according to applicable regulatory requirements.
E. SPL – STRUCTURED PRODUCT LABELING
SPL is an electronic format used for structured pharmaceutical product information and labelling.
It helps standardise the submission and exchange of product information.
F. LCM – LIFE CYCLE MANAGEMENT
Life Cycle Management refers to regulatory activities performed throughout the lifecycle of an approved pharmaceutical product.
These activities may include manufacturing changes, labelling updates, regulatory amendments and other post-approval changes.
12. CAREER OPPORTUNITIES AND LEARNING
This role can provide exposure to:
Pharmaceutical regulatory operations.
Global regulatory submission processes.
Electronic submission management.
Regulatory documentation.
Pharmaceutical product lifecycle management.
CMC documentation.
Regulatory compliance processes.
Healthcare operations.
International pharmaceutical regulatory workflows.
With relevant experience and further training, candidates may explore career opportunities in:
Regulatory Affairs Operations.
Regulatory Submission Management.
Regulatory Publishing.
Regulatory Documentation.
Life Cycle Management.
CMC Regulatory Operations.
Pharmaceutical Regulatory Services.
13. IMPORTANT JOB DETAILS
|
PARTICULARS |
DETAILS |
|---|---|
|
Company |
Accenture |
|
Job Title |
Health Operations New Associate |
|
Job Number |
AIOC-S01674577 |
|
Department |
Healthcare Operations |
|
Primary Skill |
Life Sciences Regulatory Operations |
|
Skill Level |
P3 |
|
Employment Type |
Full Time |
|
Qualification |
Any Graduation |
|
Experience |
0–1 Years (overview) |
|
Job Location |
Chennai |
|
Shift |
9 PM–6 AM IST |
|
Work Model |
100% WFO for first 6 months |
|
Hybrid Option |
Based on performance |
|
Rotational Shifts |
May be required |
14. OVERALL JOB OBJECTIVE
The primary objective of the Health Operations New Associate is to support pharmaceutical regulatory operations by coordinating regulatory documentation and processing electronic submissions for global pharmaceutical applications.
The role focuses on original application filings and Life Cycle Management submissions, including CMC, Ad-Promo, amendments, annual reports and SPL submissions.
The selected candidate will work under supervision, follow established procedures and contribute to the accurate and timely completion of regulatory operational activities.
15. KEY FOCUS AREAS OF THIS ROLE
Life Sciences Regulatory Operations.
Pharmaceutical Regulatory Documentation.
Global Regulatory Applications.
Electronic Submissions.
Original Application Filings.
Life Cycle Management (LCM).
CMC Submissions.
Ad-Promo Submissions.
Regulatory Amendments.
Annual Reports.
Structured Product Labeling (SPL).
Healthcare Operations.
Documentation Management.
Regulatory Process Compliance.
Quality Assurance.
16. APPLICATION DETAILS
JOB TITLE: Health Operations New Associate
COMPANY: Accenture
LOCATION: Chennai, Tamil Nadu
JOB NUMBER: AIOC-S01674577
Apply through the official Accenture Careers portal by searching for the job number AIOC-S01674577.
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