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Senior Medical Writer

Celegence
5+ years
Not Disclosed
Bangalore, India
-10 June 15, 2026
Job Description
Job Type: Full Time Hybrid Education: Bachelor’s or Master’s degree in Technical , Life Sciences , Biology, Biochemistry, Molecular Biology Skills:

Medical Writer / Senior Medical Writer – Regulatory Affairs

About the Company

Celegence LLC is a privately owned company headquartered in Chicago, Illinois, with offices in the UK and Bangalore. The company provides consulting services, technology solutions, and regulatory affairs support to life sciences organizations worldwide.

Celegence specializes in helping clients achieve global regulatory compliance through:

  • Regulatory Affairs consulting and operations support
  • Regulatory technology solutions
  • End-to-end regulatory compliance services
  • Innovative platforms to improve efficiency in regulatory processes

Their mission is to enable life sciences organizations to deliver exceptional patient value through comprehensive regulatory solutions.


Educational Qualifications

Required

  • Bachelor's Degree in Life Sciences or a related field

Preferred

  • Master's Degree in a relevant Life Sciences discipline

Experience Requirements

  • Minimum 5+ years of experience in Medical Writing
  • Experience in regulatory submissions and documentation
  • Expertise in:
    • Clinical claims assessment
    • Benefit-risk evaluation
    • Safety and performance data interpretation
    • Clinical Evaluation Reports (CERs)

Key Responsibilities

Clinical & Regulatory Documentation

  • Prepare and review clinical evaluation and regulatory documents
  • Assess clinical claims, benefits, safety, and performance data
  • Conduct CER strategy assessments and gap analyses
  • Provide scientific justification for identified gaps
  • Resolve Notified Body observations related to:
    • Technical files
    • Clinical documents
    • Regulatory submissions

Quality Review & Mentorship

  • Review work completed by trainees and junior writers
  • Provide training and mentoring support
  • Ensure document quality and regulatory compliance

Stakeholder & Client Support

  • Understand customer requirements
  • Deliver projects within agreed timelines
  • Collaborate with internal teams and external stakeholders

Technical / Functional Skills

Regulatory & Medical Writing

  • Strong knowledge of:
    • Clinical Evaluation Reports (CERs)
    • Regulatory requirements
    • Clinical evaluation processes
    • General Safety and Performance Requirements (GSPRs)

Scientific & Medical Knowledge

  • Ability to interpret scientific data and literature
  • Strong understanding of:
    • Medical terminology
    • Clinical research data
    • Safety and performance evidence

Software & Tools

  • Microsoft Office Suite:
    • Word
    • Excel
    • Outlook

Preferred Tools

  • PowerPoint
  • Visio
  • Zotero
  • EndNote

Non-Technical Skills

  • Excellent written and verbal communication
  • Team collaboration and interpersonal skills
  • Strong learning mindset and willingness to upskill
  • Ability to multitask effectively
  • Time management and deadline adherence
  • Customer-focused approach
  • Mentoring and coaching abilities

Personal Traits

  • Positive attitude
  • Initiative and commitment
  • Detail-oriented approach
  • Team player
  • Focused and sincere
  • Perseverance and resilience

Core Competencies

Language & Communication

  • Strong English grammar and punctuation
  • Effective sentence construction
  • Excellent written and verbal communication

Analytical Skills

  • Logical comprehension
  • Critical thinking
  • Quality-focused mindset

Domain Knowledge

  • Medical terminology
  • Clinical and regulatory documentation

Professional Skills

  • Time management
  • Stakeholder management
  • Quality assurance and attention to detail

Ideal Candidate Profile

The ideal candidate is an experienced medical writer with strong regulatory affairs expertise, capable of preparing and reviewing clinical evaluation documents, managing stakeholder expectations, mentoring junior team members, and ensuring compliance with global regulatory requirements while maintaining high-quality standards.