Senior Medical Writer/Principal Medical Writer - Regulatory Writing

About the role

The Senior Medical Writer provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients and demonstrates subject matter and therapeutic area expertise. The Senior Medical Writer may assist program managers, collaborate with internal and external clients, and support effective communication that results in operational excellence.

Responsibilities

• Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies.
• Research, write, or edit complex clinical and scientific and program-level documents, including Investigator Brochures (IBs), Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs).
• Review routine documents prepared by junior team members.
• Provide training and mentorship for junior writers and program managers on document preparation, software use, document types, regulatory requirements, and therapeutic area knowledge.
• Ensure compliance with quality processes and requirements for assigned documents.
• Provide input on and independently develop best practices, methods, and techniques for achieving optimal results, including client-specific processes.
• May assist in program management activities, including developing timelines, budgets, forecasts, and contract modifications.
• Identify and resolve out-of-scope activities.
• Represent the department at project launch meetings, review meetings, and project team meetings.

Requirements

• Bachelor’s degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; Advanced degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Experience working in the pharmaceutical/CRO industry preferred.
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
• In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered sufficient.

Skills

• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills.
• Strong project management skills.
• Excellent interpersonal skills, including problem-solving.
• Strong negotiation skills.
• Excellent oral and written communication skills with strong presentation skills.
• Significant knowledge of global, regional, national, and other document development guidelines.
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, or communications.
• Great judgment and decision-making skills.
• Excellent computer skills and proficiency with client templates.
• Good knowledge of document management systems and other relevant applications (e.g., Excel, Outlook).

Environmental Conditions

• Standard office environment (Monday–Friday).

Benefits

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.