Medical Writing Manager - based Europe
Are you a career medical writer, who thrives on a busy and varied workload in a global working environment?
Demand for Medical Writing services from Quintiles continues to grow! We are looking for new colleagues to join our enthusiastic, loyal and friendly team and help us to help our customers get new medicines to patients. If you are looking for a senior role in which you will lead challenging projects in an international working environment, share your experience with others, and help to grow our business further, with an employer that cares about its staff and values a good work-life balance, Quintiles could be the company for you.
To meet our needs, the successful applicant will have:
- extensive experience working as the Lead Medical Writer on protocol and CSR projects in Phase II and III. Experience in authoring CTD modules 2.5, 2.7.3, or 2.7.4, and/or in leading/coordinating a CTD would be a distinct advantage.
- confident and effective leadership and relationship building skills, and a track record in communicating confidently, assertively, and diplomatically with project teams, both verbally and in writing, to gain consensus and drive documents to completion on time
- a solid scientific academic background, together with a deep understanding of clinical drug development.
The successful applicant should also be able to:
- understand and interpret study objectives and clinical trial data and the regulatory and scientific requirements of the documents we prepare
- confidently work with others to develop study protocols from brief outlines, and take responsibility for a variety of clinical documents for a wide range of both international and local sponsors, across all therapeutic areas
- coordinate and lead local and global writing teams for programs of studies
- interact directly with international project team members and sponsors, proactively manage his/her own deliverables, and identify and respond appropriately with solutions to any potential issues and problems
- balance project lead roles with review responsibilities for others, support colleagues on a planned or ad hoc basis, and effectively manage and prioritise workload
- work with minimal direction, identify project needs, and create project timelines
- provide effective feedback and guidance to more junior staff
Bachelor’s degree in a life science-related discipline, with at least 5 years’ broad-ranging experience as a medical writer
within a pharmaceutical environment, including extensive experience in preparing clinical study protocols and reports, with
consistently positive customer feedback; or equivalent combination of education, training and experience
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