Principal Medical Writer

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

Zusammenfassung

Join a forward-thinking company as a Principal Medical Writer, where you will lead the development of regulatory documents for global submissions. This role offers the opportunity to manage medical writing projects, ensuring compliance with international standards while collaborating with diverse teams. With a focus on well-being and work-life balance, the organization provides a supportive environment that values high performance and nurtures talent. If you are passionate about making a significant impact in the biopharmaceutical industry, this is the perfect opportunity for you.

Leistungen

Health Insurance Options

Annual Leave Entitlements

Retirement Planning Options

Employee Assistance Programme

Life Assurance

Flexible Benefits

Qualifikationen

• 6+ years of medical writing experience in biopharmaceutical/CRO industry.
• Proficient understanding of regulatory requirements across clinical development.

Aufgaben

• Develop regulatory documents for submission to global agencies.
• 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 Sciences

Master's degree in Life Sciences

Jobbeschreibung

Overview

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

You will lead, manage, and coordinate all internal and external writing activities related to the preparation, compilation, and submission of applications to regulatory authorities worldwide.

Responsibilities

What you will be doing:

• Develop regulatory documents for submission to global regulatory agencies, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews. These should comply with ICH guidelines, other global standards, and Incyte authoring standards, adhering to study/project timelines and corporate objectives.
• 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.
• Participate in cross-functional meetings to provide input on medical writing deliverables, timelines, and processes necessary for completing regulatory documents.
• 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 sciences discipline; a Master's degree is preferred.

- Having at least 6 years of medical writing experience within the biopharmaceutical/CRO industry.

- Experienced in regulatory writing, including Clinical Study Reports, IBs, and Protocols.

- Oncology experience is a plus.

- Possessing a proficient understanding of domestic and international regulatory requirements and therapeutic areas across all phases of clinical development.

- Skilled in organizing and communicating clinical information effectively.

- Demonstrating 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. Besides a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements
• A range of health insurance options for you and your family
• Competitive retirement planning options
• Global Employee Assistance Programme, TELUS Health, providing 24/7 support from over 80,000 professionals
• Life assurance
• Flexible, country-specific benefits such as childcare vouchers, bike schemes, gym memberships, travel passes, and health assessments

At ICON, inclusion & belonging are core to our culture. 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.