Principal Medical Writer
Key People Limited
il y a 17h

An excellent opportunity has arisen to join a leading pharmaceutical company as a Principal Medical Writer to work with the Clinical Research & Development department.

This position involves the development of study-related documents, communication with health authorities, publications and presentations.

The Principal Medical Writer (PMW) ensures compliance with international guidelines and internal quality standards and is accountable for the process of authoring, reviewing and reconciliation of comments (following internal and external reviews), and finalisation / approval of documents.

The PMW is responsible for timely delivery of well-written concise documents that are supported by data and suited to the target audience and intended purpose.

Main responsibilities : Writing : *Author documents such as protocols / amendments, informed consent forms (ICFs), clinical study reports (CSRs), Investigator's Brochures (IBs), briefing books, response documents, Paediatric Investigation Plans (PIPs).

Manage review cycles, reconciliation of comments, and finalisation / approval of these documents.*Review work of other writers (contractors or internal functional area representatives) for accuracy, quality, focus, and adherence to format and stylistic requirements.

You will also be involved in leadership, strategy, Collaboration with other line management colleagues, quality management and resource management.

Your profile : *Minimum university life science degree or equivalent is required. Master's degree in a scientific area is preferred.

  • 7 years medical writing experience and / or other relevant pharma industry experience combined with the knowledge of drug development and regulatory requirements, plus extensive knowledge of medical writing processes.
  • Proven experience in writing protocols, protocol amendments, briefing books, study reports, Health Authority responses, IBs, CSRs, ICFs.
  • Experience in early phase clinical development in Oncology.*In-depth knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.
  • used for the preparation of clinical documents.*Good command of English and solid writing / editorial skills (understandable, at a level appropriate to the audience and the project).

  • Strong ability to prioritize and manage multiple demands and projects with respect to deadlines.*Ability to communicate scientific or medical information in a clear and concise manner.
  • Ability to interpret data, identify any limitations.*Self-starter, flexible, able to adapt quickly in a fast-moving environment, work efficiently within the given time and resources.
  • Ability to work with teams, establish trust, challenge appropriately and focus on results.*Ability to lead and influence.
  • Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries.

    Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment.

    Please contact Mark Cussens, Clinical Research Recruiter on Tel : +44 1727 817623 or email : mcussens Tel : +41 4350 86620 or email : mark.

    cussens Key People is a recruitment company with a reputation for providing good value that's been built up over 20 years.

  • We achieve results faster-Our candidates really are a cut above-We add greater valueWe think it's because we're a private company driven by clients, not by shareholders.
  • For our candidates, we have developed relationships with thousands of clients nationwide and across Europe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career.

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