Lead Medical Writer, Regulatory — Remote

ThermoFisher Scientific; Polska; Hybrid; PLN 180,000 - 260,000; Full time

Benefits offered by this job

Award-winning learning and development

Flexible working culture

Global organization with local feel

Job summary

Thermo Fisher Scientific's PPD clinical research services is expanding its Medical Writing FSP Team in Europe, seeking a Principal Medical Writer for a remote role dedicated to a client in the FSP space.

You will provide high-quality medical and scientific writing from planning through final drafts, review documents, and mentor junior writers. You will advise on document development strategy, regulations, and industry best practices, collaborating with clients for operational excellence.

Qualifications

• Significant knowledge of global, regional, national, and other document development guidelines.
• In-depth knowledge in one or more specialty areas such as preclinical, regulatory, submissions, communications, etc.
• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills.
• Excellent project management skills.
• Advanced interpersonal, oral, and written communication, and presentation skills.
• Excellent negotiation skills.
• Excellent judgment; high degree of independence in decision making and problem solving.
• Ability to mentor and lead junior level staff.

Responsibilities

• Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.
• May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs; provides senior level review and mentorship.
• Ensures compliance with quality processes and requirements for assigned documents; develops and reviews best practices and leads process improvement initiatives.
• Represents the department at project launch meetings, review meetings, and project team meetings.

Skills

Medical writing

Project management

Communication

Mentoring

Regulatory knowledge

Negotiation

Independent decision making

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Thermo Fisher Scientific's PPD clinical research services is expanding its Medical Writing FSP Team in Europe, seeking a Principal Medical Writer for a remote role dedicated to a client in the FSP space.

You will provide high-quality medical and scientific writing from planning through final drafts, review documents, and mentor junior writers. You will advise on document development strategy, regulations, and industry best practices, collaborating with clients for operational excellence.