
201 - 500 employees
đ„ Healthcare
đŒ Consulting
đŠ Logistics
Healthcare âą Consulting âą 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.
đ April 9
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201 - 500 employees
đ„ Healthcare
đŒ Consulting
đŠ Logistics
Healthcare âą Consulting âą 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.
âą Author and review regulatory & other medical writing deliverables independently âą Support in building technical & functional expertise within the group âą Contribute/support other writers for manuscripts, slide sets, abstracts, posters, and other techno-commercial documents âą Authoring & reviewer of CSRs, Protocol, IB, Briefing books & other regulatory submission documents for US FDA, EMEA and rest of the world âą Work with data analysts and statisticians on Real world and evidence generation projects âą Undertake quality control (QC, scientific reviews and/or proofreading of deliverables) âą Conduct client/KOL interactions, kickoff meetings, and teleconferences âą Act as project lead/delivery lead for assigned client âą Support innovation initiatives including automation and process improvement âą Conduct robust training programs for the team
âą Education: PharmD, M. Pharm, PhD, MD, Post-graduate degree in Life science/medical/para medical âą At least 10-11 years of experience in medical writing, drug development, clinical research âą At least 5 years in core medical writing (regulatory deliverables) âą Proficient with Microsoft Office Suite âą Advanced level expertise for MS WORD features and macro relation functionalities âą Excellent written and oral communication skills âą Excellent presentation skills âą Strong organizational, problem-solving, and analytical skills âą Ability to manage priorities and workflow âą Versatility, flexibility, and a willingness to work within constantly changing priorities âą Proven ability to handle multiple projects and meet deadlines âą Strong interpersonal skills. âą Creative, flexible, and innovative team player. âą Good judgment with the ability to make timely and sound decisions.
âą Competitive salary âą Flexible working hours âą Professional development opportunities âą Remote work options
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