Senior Medical Writer

Pharmaceutical Research Associates, Inc; Burgenland; Hybrid; EUR 60 000 - 100 000; Vollzeit

Zusammenfassung

Join a leading clinical research organization as a Senior Medical Writer, where you'll develop essential regulatory documents and manage writing projects. This role emphasizes collaboration with cross-functional teams to ensure timely submissions to global regulatory agencies. The ideal candidate will have extensive experience in medical writing, particularly in the biopharmaceutical industry, and possess strong communication and project management skills. Enjoy a supportive work environment that values diversity and offers a competitive salary along with numerous benefits to promote work-life balance.

Leistungen

Annual leave entitlements

Health insurance options

Retirement planning options

Global Employee Assistance Programme

Life assurance

Flexible benefits like gym discounts

Qualifikationen

• 6+ years of medical writing experience in biopharmaceutical/CRO industry.
• Proficient in regulatory writing for Clinical Study Reports and Protocols.

Aufgaben

• Develop regulatory documents for global submissions following ICH guidelines.
• Manage medical writing projects and collaborate with cross-functional teams.

Kenntnisse

Medical Writing

Regulatory Writing

Project Management

Communication Skills

Organizational Skills

Ausbildung

Bachelor's degree in Life Science

Master's degree in Life Science

Jobbeschreibung

Overview

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

Responsibilities

What you will be doing:

1. Develop regulatory documents for submission to global regulatory agencies, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, following ICH and other international guidelines, standards, and Incyte authoring standards, while adhering to study/project timelines and corporate objectives.
2. Manage medical writing projects by developing timelines in collaboration with study/project teams and communicating with cross-functional team members to ensure awareness of review cycles and expectations.
3. Participate in cross-functional meetings to provide input on medical writing deliverables, timelines, and processes necessary for the completion of regulatory documents.
4. Review related documents such as Protocols and Statistical Analysis Plans, as appropriate.

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Qualifications

You are:

• Holding a Bachelor's degree in a life science discipline; a Master’s degree is preferred. At least 6 years of medical writing experience in the biopharmaceutical/CRO industry is required.
• Experienced in regulatory writing, including Clinical Study Reports, IBs, and Protocols.
• Oncology experience is a plus.
• Proficient in understanding and applying domestic and international regulatory requirements, with knowledge of therapeutic areas across all phases of clinical development.
• Capable of organizing and communicating clinical information effectively.
• Possessing strong communication, organizational, time management, and project management skills.

What ICON can offer you: Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme, TELUS Health, providing 24/7 support through a network of professionals
• Life assurance
• Flexible country-specific benefits, such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

At ICON, inclusion & belonging are fundamental. We are committed to providing an inclusive, accessible environment free of discrimination and harassment. All qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.