Senior Medical Writer - Global Clinical Research Organisation - Home based in UK

JR United Kingdom; Wakefield; On-site; GBP 50,000 - 75,000; Full time

Job summary

Une organisation de recherche clinique mondiale recherche un Senior Medical Writer pour rédiger des documents cliniques complexes. Ce rôle implique la direction de projets, l'encadrement de rédacteurs juniors et la rédaction de documents pour des soumissions réglementaires. Un bon niveau d'expérience en rédaction médicale et en gestion de projet est requis.

Qualifications

• Expérience en rédaction de protocoles et rapports cliniques de phases I à III.
• Capacités en gestion de projet et leadership.
• Historique en tant que rédacteur médical et leader de projet.

Responsibilities

• Rédaction de documents cliniques complexes pour des soumissions réglementaires.
• Supervision et encadrement de rédacteurs médicaux juniors.
• Gestion de plusieurs projets pour un sponsor unique.

Skills

Rédaction médicale

Gestion de projet

Gestion des parties prenantes

Leadership

Job description

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Senior Medical Writer - Global Clinical Research Organisation - Home based in UK, Wakefield

Planet Pharma is currently working with a global clinical research organisation (CRO) that is looking for an experienced Medical Writer to join the team and support the preparation of submission and other complex clinical documents.

As a Senior Medical Writer, you will be responsible for authoring high-complexity study-level documents including protocols, ICFs, investigator brochures, and meeting packages. You will also independently author:

• Clinical evaluation plans and clinical evaluation reports
• Paediatric Investigational Plans (PIPs)
• Clinical summary and overview documents in CTD/eCTD formats for global regulatory submissions

This is an exciting opportunity to join a globally renowned CRO and play a significant role in bringing key therapies to market across various therapeutic areas. You will be assigned to one sponsor, leading multiple projects, and supervising or guiding junior medical writers.

For this position, our client seeks someone with experience as a medical writer and project lead on medical writing projects.

You should also have experience with:

• Phase I - III protocol and CSR medical writing
• Stakeholder management, both internal and external
• Project management and leadership skills

For more information, please contact Chanel Hicken at 0203 868 1011 or email your updated CV to [email protected], and we can arrange a confidential discussion about this exciting opportunity.