Background
A leading biopharmaceutical company needed expert medical writers to work with Clinical Development, Operations, Medical Science, Affairs, Regulatory, and Program Management. Their task was to create high-quality clinical and regulatory documents, like protocols and study reports, following company and agency guidelines to support drug development on tight schedules.
The company sought writers who could manage and mentor others, and efficiently use the document management system and tools to ensure consistent, high-quality document production and publishing.
Challenge
The primary challenge was to find medical writers with the right expertise and experience to meet the company’s stringent requirements. The ideal candidates needed to thrive in a fast-paced, innovative environment, possess excellent interpersonal skills, and have a strong background in biological sciences, preferably with advanced degrees in neuroscience, psychiatry, or related fields. They also needed to have extensive experience in medical writing, drug development, clinical research, and regulatory environments.
Solution
Vita Global Sciences offered a Functional Service Provider (FSP) medical writing solution. Initially, VGS placed a lead medical writer for our client that later became their hiring manager. Over two years, a team of writers from VGS collaborated closely with the client.
The team prepared high-quality clinical and regulatory documents, trained and mentored writers, ensured efficient document production, and contributed to template and standard design. They also represented Medical Writing on cross-functional teams and supported continuous improvement initiatives.
VGS presented eight hirable candidates to our client. The search began, and within a five weeks, the first placement was made. This rapid and efficient process ensured the client quickly received the necessary medical writing support to meet their drug development timelines while maintaining high standards of quality and productivity.