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Vacancy details
Vacancy description:
Job Code:
J746819
Job Title:
Senior / Lead Medical Writer
Job Category:
Medical Information
Contract:
Permanent
Discipline:
Medical Information, Medical Writing, Medical Communication
Country:
United Kingdom
Location:
Berkshire, Hampshire, London - Central, Surrey, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
40000 - 60000 £
Apply by:
27 Jul 2008
Lead Medical Writer
Our client is a leading speciality Biopharmaceutical company focused upon meeting the needs of the specialist physician, with a broad range of products this is a fantastic opportunity for an experienced Medical Writer based in the South of South East.
Job Summary
Reporting to the Head of Medical Writing, the Lead Medical Writer will be responsible for leading the medical writing activities for multiple projects or a business unit.
Responsible for:
*Timely preparation of investigators' brochures, study reports, integrated summaries, clinical overviews, contributions to briefing documents, response documents, and other global regulatory submission documents, ensuring high quality with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
*Supports the clinical project team(s) as the Medical Writing representative and oversees/coordinates work of other writers (internal or contractors).
*Leads efforts for establishing departmental guidelines and cross-functional initiatives.
*Responsible for resource assessments within assigned projects/business unit.
Key Responsibilities
*Responsible for all medical writing activities within assigned projects / business unit.
*Actively support clinical project team(s), representing Medical Writing and bearing responsibility for timely and accurate MW deliverables, negotiating timelines and procuring resources as necessary.
*With a high level of independence, write, edit, or otherwise facilitate completion of clinical documents (all document types).
*Manage writing, editing, QC, and publishing activities for programs within assigned project/ business unit.
Delegate and manage clinical project writing activities assigned to contract medical writers
*Proactively prepare writing plans for projects, including contingency plans and issue resolution strategies
*Provide strategic direction to the clinical project team relative to consistency of key messages across documents within a project and regulatory requirements/guidance for submission documents.
*Mentor supporting medical writers, and ensure the quality and timeliness of their deliverables.
*Lead departmental and cross-functional process improvement initiatives.
*Contribute to departmental strategic planning.
Educational & Experience Requirements
*PhD or equivalent degree in a relevant scientific/clinical/regulatory field preferred
*Have significant broad range experience in clinical/pharmaceutical development
*Global regulatory submission experience
Key Skills and Competencies
*Excellent writing skills.
*Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by the clinical team.
*Strong oral and written presentation skills.
*Ability to interact effectively with team leaders/members and be able to proactively facilitate effective information exchange/communication (including problem solving and issue resolution).
*Knowledge of current regulatory requirements and guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents.
*Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.
*Working knowledge of template use for document creation.
*Ability to work with different template styles and types.
*Ability to prioritize multiple projects.
Key Words: Medical Writer Lead Medical Writer MW Medical Information Biotechnology Pharmaceutical South South East Hampshire Berkshire Middlesex London Wiltshire Relocatable UK Anywhere Research and Development Management Manager
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