Principal Medical Writer 1, Associate Director

ICON Strategic Solutions; Deutschland; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A leading clinical research organization in Germany is seeking a Principal Medical Writer to develop high-quality regulatory and clinical documents. You will manage projects, communicate with cross-functional teams, and ensure compliance with industry standards. The ideal candidate will have at least 6 years of experience in medical writing within the biopharmaceutical industry, along with strong communication and organizational skills.

Leistungen

Competitive salary

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Flexible optional benefits

Qualifikationen

• At least 6 years of medical writing experience in the biopharmaceutical/CRO industry required.
• Regulatory writing experience - Clinical Study Reports, IBs, Protocols.
• Proficient understanding of domestic and international regulatory requirements.

Aufgaben

• Develop regulatory documents for submission to regulatory agencies globally.
• Manage medical writing projects and communicate with cross-functional team members.
• Review other documents associated with assigned project(s).

Kenntnisse

Medical writing expertise

Communication skills

Project management skills

Organizational skills

Ausbildung

Bachelor's degree in life science

Master's degree in life science (preferred)

Jobbeschreibung

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients’ submissions to regulatory authorities and ensuring compliance with industry standards.

What You Will Be Doing

• Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.

Your Profile:

• A Bachelor\'s degree in a life science discipline, with Master\'s degree in life science discipline preferred.
• At least 6 years of medical writing experience in the biopharmaceutical/CRO industry required.
• Regulatory writing experience - Clinical Study Reports, IBs, Protocols
• Oncology experience would be a plus
• Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.
• Proficiency in organizing and communicating clinical information necessary.
• Strong communications, organizational, time management, and project management skills are 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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At 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, color, 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 or submit a request here.

Interested 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.

Are you a current ICON Employee? To apply, visit the ICON careers site.