MASUU Global Careers – Hiring Medical Writer – Regulatory Writing

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MASUU Global, a leading company in pharma regulatory, quality services, and software solutions, is expanding its team in Hyderabad. We are hiring skilled professionals for Medical Writing – Pharma Safety & Regulatory Documents. If you are passionate about regulatory submissions, compliance, and scientific writing, this is your opportunity to work with a global leader.

Job Details

  • Position: Medical Writer – Regulatory Writing
  • Vacancies: 2
  • Type: Full-Time (Immediate Joiners / <30 Days Notice)
  • Location: Hyderabad – Miyapur (Onsite, No Work From Home)

Experience Levels

  • Managerial Role: 8–10 Years
  • Executive Role: 2–4 Years

Key Responsibilities

  • Author, review, and manage clinical and regulatory documents supporting global regulatory submissions.
  • Contribute to regulatory interactions (Type A, B, C meetings).
  • Ensure alignment with ICH and global regulatory requirements.
  • Collaborate with cross-functional teams: PV, Clinical, Regulatory, Safety, and Legal.
  • Mentor junior writers and conduct peer reviews.
  • Support regulatory writing strategies and deliverables.

Prepare and finalize critical documents including:

  • CTD Modules 2.5 & 2.7
  • Risk Management Plans (RMP)
  • Initial Paediatric Study Plans (IPSP)
  • Study Protocols & Investigator Brochures (IB)
  • Pre-IND / IND documents
  • IMPDs & Scientific Advice Packages
  • PSURs & PBRERs

Ideal Candidate Profile

  • Strong knowledge of regulatory writing standards and compliance.
  • Ability to handle multiple projects within strict timelines.
  • Excellent communication and teamwork skills.
  • Proven expertise in authoring documents for regulatory submissions.

How to Apply

Interested candidates can send their CVs in the specified format:
📧 Email: hiring@masuuglobal.com
📱 Call / WhatsApp: 9154979318
🔗 LinkedIn (HR Contact): Harika Challagurugula
🌐 Visit: www.masuuglobal.com

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Subject Line: CV for Medical Writer

MASUU Global Careers – Hiring Medical Writer – Regulatory Writing

Why Join MASUU Global?

  • Opportunity to work with leading experts in pharma regulatory writing.
  • Be part of an innovative, fast-growing company with global exposure.
  • Contribute to critical regulatory submissions impacting international markets.
  • Build your career in a supportive and collaborative environment.

🚀 Join MASUU Global and make a difference in the future of regulatory science and global healthcare.

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