Sr Principal Medical Writer at ICON Strategic Solutions Remote

Salón Večná kráska; United States; Remoto; USD 150.000 - 230.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual leave entitlements

Health insurance

Retirement planning

Global Employee Assistance Programme (

Life assurance

Country-specific benefits

Descrizione del lavoro

ICON plc, a world-leading healthcare intelligence and clinical research organization, is seeking a Senior Principal Medical Writer to lead development of high-quality clinical and regulatory documents. The role requires mentoring junior writers, collaborating with cross-functional teams, and ensuring regulatory compliance.

The candidate will oversee complex documents, stay updated on industry trends, and contribute to process improvements while working in a remote environment.

Competenze

• Master’s degree or Ph.D. in Life Sciences, Medicine, or related field.
• Extensive medical writing experience in pharma/biotech, clinical/regulatory documents.
• Strong scientific writing/editing with high attention to detail.
• Excellent analytical/problem-solving for complex clinical data.
• Demonstrated leadership with team mentoring experience.
• Exceptional communication to diverse audiences.

Mansioni

• Develop and author clinical and regulatory documents (CSRs, protocols, IBs, regulatory submissions).
• Ensure regulatory guidelines and company standards are met for quality and accuracy.
• Collaborate with cross-functional teams to gather/interpret data.
• Mentor junior medical writers and promote continuous improvement.
• Review/edit documents for consistency and regulatory compliance.
• Stay current with industry trends and regulatory changes.

Conoscenze

Scientific writing

Leadership

Attention to detail

Analytical skills

Communication

Formazione

Master’s degree in Life Sciences

Ph.D. in Life Sciences or related field

Descrizione del lavoro

Sr Principal Medical Writer job at ICON Strategic Solutions. Remote. Sr. Principal Medical Writer 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 Senior Principal Medical Writer to join our diverse and dynamic team. As a Senior Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality clinical and regulatory documents, ensuring clarity, accuracy, and compliance with industry standards.

What You Will Be Doing:

• Developing and authoring clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions.
• Ensuring all documents comply with regulatory guidelines and company standards for quality and accuracy.
• Collaborating with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to gather and interpret clinical data.
• Mentoring and guiding junior medical writers, fostering a culture of excellence and continuous improvement.
• Reviewing and editing documents prepared by other writers to ensure consistency and adherence to regulatory requirements.
• Staying current with industry trends and regulatory changes to integrate best practices into medical writing processes.
• Contributing to the development of templates, style guides, and standard operating procedures to enhance the efficiency and quality of medical writing activities.

Your Profile:

• A master’s degree or Ph.D. in Life Sciences, Medicine, or a related field.
• Extensive experience in medical writing, with a proven track record of developing clinical and regulatory documents in the pharmaceutical or biotech industry.
• Strong proficiency in scientific writing and editing, with excellent attention to detail.
• Excellent analytical and problem-solving skills, with the ability to interpret complex clinical data and present it clearly.
• Demonstrated leadership skills, with experience in managing and mentoring teams effectively.
• Exceptional communication skills, with the ability to convey technical concepts to diverse audiences.
• Detail-oriented, with strong organizational skills to manage multiple projects and deadlines in a dynamic environment.

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