Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
An exciting opportunity to act as the Lead Medical Writer for Consumer Health Studies for a UK based Pharmaceutical company in a standalone European role, working collaboratively with colleagues in North America & Asia.
The Principal Medical Writer will work as part of INC Research / inVentiv Health’s FSP model dedicated to single sponsor studies for our leading pharmaceutical client.
The position holder will be the lead Medical Writer on global trials and across multiple consumer health studies including oral health, nutrition and skin health. This is a new partnership and an exciting time to come onboard to standardise processes and drive initiatives and quality forward.
The Principal Medical Writer will prepare, review and edit key documents for regulatory submission or for publication/presentation, providing technical leadership or support to other writers, ensuring that clinical data is presented in documents in compliance with applicable regulatory guidelines.
Develop a variety of documents related to regulatory, submissions, abstracts, posters, publications, presentations, medical information letters, records, press releases, brochures, and etc.
Apply appropriate scientific criteria to ensure that client objectives are met and quality standards are maintained.
Comply with client or company procedures for completing deliverables, obtaining reviews, incorporating edits, and working with teams to complete and finalize deliverables.
Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments.
Keep management and team members informed of project status and actively lead team meetings.
Review and edit documents to give maximum clarity of meaning, accuracy relevance, and consistency of style and format to ensure that client objectives are met and overall quality standards are maintained.
Continue professional development to keep pace with regulatory guidance and client expectations.
Stay aware of the budget and timeline specifications for all assigned projects, working within the budgeted hours and communicating any changes to specifications to the manager or other medical writing leaders as appropriate.
Complete all administrative tasks within specified timeframes.
Develop good working relationships with internal and external colleagues.
Interact with clients regarding project expectations and performance.
Participate in presentations to clients as requested.
Support business development activities.
Lead and support special projects as requested.
Education and experience required
Bachelor’s of Science, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience.
MS, MPH, PharmD, PhD, or other advanced degree is strongly preferred.
Minimum eight years relevant experience in scientific, technical or medical writing
Proven track record of scientific writing along with a strong scientific background
Strong client management, project management and team leadership skills
Previous experience in a CRO environment (preferred)
Previous exposure to proposal development and financial management (preferred)
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade