Principal Medical Writer

This is a fully remote position, open to applicants in India.

📋 Description

• Independently write and review regulatory and other medical documentation.

• Assist in developing technical and functional knowledge within the team.

• Collaborate and provide support to other writers for manuscripts, slide presentations, abstracts, posters, and various techno-commercial documents.

• Responsible for authoring and reviewing Clinical Study Reports (CSRs), protocols, Investigator Brochures (IB), briefing books, and other regulatory submission materials for the US FDA, EMEA, and global markets.

• Collaborate with data analysts and statisticians on real-world evidence generation projects.

• Perform quality control, including scientific reviews and proofreading of deliverables.

• Facilitate client and Key Opinion Leader (KOL) interactions, kickoff meetings, and teleconferences.

• Serve as the project lead or delivery lead for assigned clients.

• Promote innovation initiatives, including automation and process enhancement.

• Implement comprehensive training programs for the team.

⛳️ Requirements

• Education: PharmD, M. Pharm, PhD, MD, or a postgraduate degree in Life Sciences, Medical, or Paramedical fields.

• A minimum of 10-11 years of experience in medical writing, drug development, and clinical research.

• At least 5 years of direct experience in core medical writing specifically for regulatory deliverables.

• Proficient in Microsoft Office Suite.

• Advanced expertise in MS Word features and macro functionalities.

• Exceptional written and verbal communication abilities.

• Strong presentation skills.

• Excellent organizational, problem-solving, and analytical capabilities.

• Ability to effectively manage priorities and workflow.

• Adaptability and willingness to work in a dynamic environment with shifting priorities.

• Demonstrated capacity to manage multiple projects and adhere to deadlines.

• Strong interpersonal skills.

• Creative, adaptable, and innovative team collaborator.

• Good judgment with the ability to make timely and informed decisions.

🏝️ Benefits

• Competitive salary.

• Flexible working hours.

• Opportunities for professional development.

• Options for remote work.