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7 дней назад

Principal Medical Writer - FSP

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
UK
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Principal Medical Writer - FSP (Clinical Research): Leading the preparation and review of clinical study reports, protocols, and other medical writing deliverables with an accent on regulatory compliance, statistical interpretation, and customer collaboration. Focus on managing complex writing projects, reviewing statistical analysis plans and outputs, mentoring junior staff, and overseeing timelines, budgets, and project risks.

Location: Reading, Berkshire, United Kingdom

Company

Global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Lead the preparation of clinical study reports, protocols, and other medical writing deliverables according to standard operating procedures and customer requirements.
  • Plan workloads, coordinate reviews, manage timelines, and communicate directly with customers.
  • Lead meetings on challenging topics and resolve customer comments and project issues.
  • Review medical writing deliverables and provide constructive feedback to junior staff and customers.
  • Manage budgets, costings, invoicing, and project finance activities for assigned projects.
  • Support training, mentoring, capability initiatives, and customer or cross-functional activities.

Requirements

  • Bachelor's or master's degree in life sciences or a related discipline; a Ph.D. is preferred.
  • At least 5 years of highly relevant experience and demonstrated competency in medical writing.
  • Significant lead-writer experience preparing clinical study reports and protocols.
  • In-depth knowledge of drug development, medical writing, applicable regulations, medical terminology, and Good Clinical Practice.
  • Understanding of clinical-trial statistical methods, statistical analysis plans, and statistical outputs.
  • Strong written and verbal communication, negotiation, attention to detail, judgment, collaboration, and multitasking skills.

Culture & Benefits

  • Opportunity to contribute to the development and commercialization of innovative medical treatments.
  • Collaboration with customers, project managers, medical writing teams, and cross-functional groups.
  • Opportunities to mentor colleagues and deliver training to local and global teams.
  • Work includes participation in regional, site, and organization-wide medical writing initiatives.

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