Scientific Writer

3 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 13,50,000
Regulatory Writer Opportunity

We are seeking an experienced regulatory writer to join our team.

The ideal candidate will have a strong background in scientific/technical writing and editing, as well as experience with complex standard operating procedures (SOPs), guidance documents, and work instructions.

  • Responsibilities include authoring and gaining approval of scientific and regulatory submission documents, working closely with cross-functional product team members to maintain key business relationships, and serving as functional area lead on product teams.
  • Key qualifications include a strong background in scientific/technical writing and editing, experience with SOPs, guidance documents, and work instructions, and knowledge of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidances and requirements.

In this critical role, you will be responsible for authoring and gaining approval of scientific and regulatory submission documents. You will work closely with cross-functional product team members to maintain key business relationships and may serve as functional area lead on product teams.

Key Responsibilities:
  • Author regulatory submission documents, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents.
  • Conduct formal review and approval of authored documents, following applicable SOPs.
  • Manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications.
  • Serve as functional area lead on product teams, providing input for the Global Regulatory Plan and team goals.
  • Participate in training and mentoring of junior medical writers, departmental, and cross-departmental initiatives.

As a highly skilled and experienced regulatory writer, you will have a strong background in scientific/technical writing and editing, as well as experience working in the pharmaceutical industry and understanding global regulatory standards.

Requirements:
  • Strong background in scientific/technical writing and editing.
  • Experience working in the pharmaceutical industry and understanding global regulatory standards.
  • Knowledge of ICH and GCP guidances and requirements.
  • Ability to conduct formal review and approval of authored documents.
  • Ability to manage regulatory writing activities for product submissions.

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