Job Purpose / Summary: Responsible for providing high-level medical writing expertise to assigned various medical writing projects; manages direct interactions with clients; includes providing substantive input to all phases of regulatory, scientific or marketing/health economics and outcomes research projects.
Duties and Responsibilities:
Responsible for preparing a wide range of documents for clients, including documents intended for submission to regulatory authorities (such as briefing documents, protocols and clinical study reports) and health economic and outcomes research-related documents (such as literature summaries, research reports and manuscripts)
Participate in/lead drug development (such as protocol development) and projects such as systematic literature reviews, global value dossiers, and epidemiologic/observational studies
Interact professionally with clients and thought-leaders to understand their objectives and meet their needs.
Participate in Business Development capabilities presentations; client visits and programs as needed
Collaborate with Medical Directors, biostatistics and programming, clinical and other disciplines as appropriate
Rely on experience and judgment to plan and accomplish goals. Perform a variety of complicated tasks. A high degree of creativity and flexibility is expected
Prioritize and manage time effectively to meet the needs of multiple clients simultaneously
Required Education & Experience:
At least five to seven years of direct prior relevant pharmaceutical/Contract Research Organization, drug development, academic or outcomes research medical writing experience
Experience in preparation of technically complex documents intended for submission to regulatory authorities (e.g., briefing documents, clinical study reports) or in experience in HECOR-related projects (e.g., development of a research plan, execution of analyses and preparation of research report/manuscript)
Demonstrated excellent technical writing and research skills
Strong experience in computer technology, including Word, PowerPoint and Excel
MS/MPH, BS/Nurse Practitioner/BSN/MSN required with relevant experience; PhD/DrPH, MD or PharmD preferred
Working knowledge of the drug development process, drug/device regulatory requirements or epidemiologic and outcomes research methodologies
Experience with literature reviews and/or systematic literature reviews
Experience working in rare disease/critical care therapeutic areas or in pharmaceutical-related outcomes research
Demonstrated experience effectively leading multi-disciplinary project teams
CTI was founded in 1999 to provide therapeutic expertise to the pharmaceutical and biotechnology industry across a range of services. We have experienced consistent and significant growth from a US-based organization to a multi-national corporation with associates in more than 25 countries across the world. We have worked on more than 2,700 projects on six continents during the company lifetime, a...nd have contributed to more than 100 new drug and device approvals through global regulatory agencies such as the FDA, EMA, and others. Visit www.ctifacts.com for more information.