London based Clinical Research Organisation looking for Medical Writers to join their team.
Effectively supervise & Manage a team of Medical Writers to deliver good quality documents within agreed timelines
Plan, prepare, write, edit, format, and finalize clinical and regulatory documents.
Documents will include, but are not limited to: clinical protocols, clinical study reports, Investigator brochures, Safety summary reports, regulatory submissions and annual updates as well as publications
Allocate resources and coordinate the internal review of documents.
Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (eg, timelines and review/revision responsibilities) with the project teams.
Ensure compliance, remain informed on regulations and developments in medical writing, as well as maintain knowledge of product areas, current trends, and current literature.
Should have experience of medical writing, ideally in a clinical trials environment within the UK or EU.
Should have a life science degree, PhD or MD with medical writing experience including first author of a minimum of two manuscripts.
Capable of understanding the underlying science and writing strategy related to assigned projects and writing more complex projects, (e.g. complex manuscripts and review articles)
demonstrates an ability to expertly use a range of resources (e.g. Microsoft office, scientific databases, referencing software, online submissions & tracking)
effectively train and manage associate medical writers, leading by example, is a team player, recognising where s/he can use his/her skills to support colleagues and direct reports