Principal Medical Writer

Pharmaceutical Research Associates, Inc; Schweiz; Remote; CHF 90’000 - 130’000; Vollzeit

Zusammenfassung

A leading clinical research organization is seeking a Senior Medical Writer to develop clinical documents for regulatory submissions. The role involves working with multidisciplinary teams to produce scientifically valid documents like clinical study reports and investigator brochures. Ideal candidates should have a degree in life sciences and significant experience in medical writing within the biopharmaceutical industry.

Leistungen

Health Insurance

Retirement Planning

Employee Assistance Programme

Flexible Benefits

Qualifikationen

• At least 4 years of medical writing experience in biopharmaceutical/CRO industry.
• Understanding of global regulatory requirements and clinical development phases.
• Proficiency in organizing and communicating clinical information.

Aufgaben

• Develop regulatory documents for submission to regulatory agencies globally.
• Participate in study/project team meetings for medical writing deliverables.
• Review other documents associated with assigned projects.

Kenntnisse

Medical Writing

Regulatory Knowledge

Communication

Document Organization

Ausbildung

Bachelor's degree in Life Science

Master's degree in Life Science

Jobbeschreibung

Overview

As a Senior Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

This position is responsible for the development of clinical documents for worldwide submissions to regulatory authorities.

Senior Medical Writer works directly with multidisciplinary project team members with the goal of independently writing scientifically valid, complete, and consistent documents, such as clinical study reports (CSRs), investigator’s brochures (IBs), and select clinical Module 2 summary documents. The Senior Medical Writer may be responsible for the medical writing activities for one or more compounds and may contribute to major submissions

Responsibilities

What you will be doing:

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives.
• Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines and any processes needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
• Assist in defining and writing standard operating procedures and working practices to allow the effective and efficient preparation of quality documents.

Location: Europe or UK remote

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Qualifications

You are:

• A Bachelor's degree in life science discipline with Master's degree in life science discipline preferred.
• At least 4 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
• Understanding and knowledge of global regulatory requirements.
• Knowledge of the various phases of clinical development required.
• Proficiency in organizing and communicating clinical information required.

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.