Instagram
youtube
Facebook

Senior Analyst โ€“ Document Publishing

4 years
Not Disclosed
10 Sept. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ 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

๐Ÿ“„ Job Title: Senior Analyst – Document Publishing

Function: Regulatory Affairs Group
Sub-function: Regulatory Product Submissions and Registration
Job Category: Senior Analyst, Regulatory Product Submissions and Registration (P6)
Location: Mumbai or Bangalore, India
Work Pattern: Fully Onsite
Date Posted: August 28, 2025
Requisition Number: R-026368
Apply Now


๐Ÿข About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Through our expertise in Innovative Medicine and MedTech, we deliver smarter, less invasive, and more personal solutions to advance global health. With a 130-year legacy, we remain committed to transforming healthcare for humanity.

๐Ÿ”— Learn more: https://www.jnj.com


๐Ÿงพ Role Overview

As a Senior Analyst – Document Publishing, you will serve as a key liaison between the authoring community and regulatory operations teams. You will ensure the delivery of submission-ready documents, maintain high quality and compliance standards, and lead process improvements within document publishing for regulatory submissions.


๐ŸŽฏ Key Responsibilities

๐Ÿ“„ Document Publishing & Process Management

  • Serve as the single point of contact for the authoring community for document publishing support.

  • Coordinate operational aspects of document-level support:

    • Resource planning

    • Scheduling

    • Gap resolution

  • Ensure submission-ready documentation per global regulatory standards.

  • Apply appropriate submission standards, requirements, and policies to comply with health agency guidelines.

  • Drive process improvements to reduce inefficiencies and improve quality.

๐Ÿ”„ Cross-functional Collaboration

  • Collaborate with:

    • Regulatory Affairs

    • Clinical teams

    • Data management

    • Safety and quality teams

  • Promote understanding of end-to-end submission processes and interdependencies.

๐Ÿ“Š Project Leadership & Monitoring

  • Lead multiple document projects with proactive oversight of:

    • Timelines

    • Scheduling

    • Strategy alignment

  • Track submission document progress across systems.

๐Ÿ“š Training & Vendor Management

  • Assist in training users on new processes or publishing software.

  • Support vendor alliance management:

    • Monitor external vendor quality

    • Contribute to vendor work orders

๐Ÿค Mentoring & Process Ownership

  • Coach/mentor junior staff on document processing procedures.

  • Provide peer review and quality checks on submission documents.

  • Participate in or lead internal working groups to improve document publishing processes.


๐Ÿ‘ฅ Key Relationships

๐Ÿ”น Internal Stakeholders

  • Manager

  • Regulatory document specialists

  • Cross-functional teams (Clinical, Regulatory, Data Management, Safety, Quality)

๐Ÿ”น External Stakeholders

  • Contractors or external publishing vendors (as needed, under supervision)


๐ŸŽ“ Education & Experience Requirements

โœ… Education

  • Preferred: Bachelor's degree (BS/BA)

  • Alternate Path: 5–8 years of relevant experience without a formal degree

โœ… Experience

  • Minimum 4 years of experience in regulatory document processing within the pharmaceutical industry

  • Expertise in:

    • Electronic document publishing tools

    • Document management systems

    • Word processing and formatting standards

  • Strong organizational and communication skills

  • Experience managing multiple projects and teams


๐Ÿง  Skills & Competencies

  • Mastery of Microsoft Word and industry-standard document tools

  • Familiarity with eCTD publishing and regulatory submission standards

  • Strong interpersonal, time management, and stakeholder coordination skills

  • Ability to lead and mentor junior colleagues


๐ŸŒ Why Join Johnson & Johnson?

At J&J, you’ll be part of a company that’s revolutionizing health with science and compassion. Join a team where your expertise directly supports global patient access to innovative therapies.

We are an equal opportunity employer and celebrate diversity and inclusion in our workforce.