Catalyst Clinical Research
201 - 500 employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Catalyst Clinical Research is a specialized clinical research organization with a focus on oncology and multi-therapeutic functional service provision for the global biotechnology and biopharmaceutical industries. Through their Catalyst Oncology division, they offer full-service oncology clinical research support, tapping into an extensive site network and experienced global teams to aid cancer drug development. Meanwhile, Catalyst Flex provides specialized functional solutions across clinical operations, data management, biostatistics, and medical writing to strengthen and customize clinical trials. As a partner in drug development, Catalyst Clinical Research delivers flexible, customizable solutions to meet the diverse needs of biotech companies, emphasizing efficiency and innovation in research.
Principal Medical Writer
Job not on LinkedIn
🕒 April 9
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Catalyst Clinical Research
201 - 500 employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Catalyst Clinical Research is a specialized clinical research organization with a focus on oncology and multi-therapeutic functional service provision for the global biotechnology and biopharmaceutical industries. Through their Catalyst Oncology division, they offer full-service oncology clinical research support, tapping into an extensive site network and experienced global teams to aid cancer drug development. Meanwhile, Catalyst Flex provides specialized functional solutions across clinical operations, data management, biostatistics, and medical writing to strengthen and customize clinical trials. As a partner in drug development, Catalyst Clinical Research delivers flexible, customizable solutions to meet the diverse needs of biotech companies, emphasizing efficiency and innovation in research.
📋 Description
• 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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