Principal Medical Writer
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Job Description
Principal Medical Writer crafting regulatory and medical writing deliverables for Catalyst Clinical Research. Collaborating on projects and supporting other writers while ensuring quality standards in medical documentation.
Responsibilities:
- Author and review regulatory & other medical writing deliverables independently
- Support in building technical & functional expertise within the group
- Contribute/support other writers for manuscripts, slide sets, abstracts, posters, and other techno-commercial documents
- Authoring & reviewer of CSRs, Protocol, IB, Briefing books & other regulatory submission documents for US FDA, EMEA and rest of the world
- Work with data analysts and statisticians on Real world and evidence generation projects
- Undertake quality control (QC, scientific reviews and/or proofreading of deliverables)
- Conduct client/KOL interactions, kickoff meetings, and teleconferences
- Act as project lead/delivery lead for assigned client
- Support innovation initiatives including automation and process improvement
- Conduct robust training programs for the team
Requirements:
- Education: PharmD, M. Pharm, PhD, MD, Post-graduate degree in Life science/medical/para medical
- At least 10-11 years of experience in medical writing, drug development, clinical research
- At least 5 years in core medical writing (regulatory deliverables)
- Proficient with Microsoft Office Suite
- Advanced level expertise for MS WORD features and macro relation functionalities
- Excellent written and oral communication skills
- Excellent presentation skills
- Strong organizational, problem-solving, and analytical skills
- Ability to manage priorities and workflow
- Versatility, flexibility, and a willingness to work within constantly changing priorities
- Proven ability to handle multiple projects and meet deadlines
- Strong interpersonal skills.
- Creative, flexible, and innovative team player.
- Good judgment with the ability to make timely and sound decisions.
Benefits:
- Competitive salary
- Flexible working hours
- Professional development opportunities
- Remote work options
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