FSP Principal Medical Writer (Regulatory) - Client-Dedicated

This is a remote principal medical writer role with Lifelancer, working on a client-dedicated basis in the FSP space. The employer's own listing places the job in the United Kingdom, though the facts supplied to us list the location as United States, so check the location before applying. You would act as lead writer on medical and scientific documents, from planning through final drafts, and serve as a subject matter expert for the team.

What you will do

• Research, write, and edit clinical study reports and study protocols, and summarize data from clinical studies.
• May serve as primary author on complex clinical, scientific, and program level documents, including IBs, INDs, and MAAs.
• Provide senior level review of routine and complex documents.
• Train and mentor other writers and program managers on document preparation, document development software, document types, regulatory requirements, and therapeutic area knowledge.
• Ensure compliance with quality processes and requirements for assigned documents.
• As subject matter expert, develop and review best practices, methods, and techniques, including client-specific processes, and lead process improvement initiatives.
• May develop, review, and manage performance metrics for assigned projects.
• Represent the department at project launch meetings, review meetings, and project team meetings.
• Collaborate with internal and external clients to support effective and efficient communication.

What they are looking for

• Bachelor's degree in a scientific discipline or equivalent relevant formal academic or vocational qualification; an advanced degree is preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job, comparable to 8+ years.
• Experience managing and directing complex medical writing projects is required.
• Experience in the pharmaceutical or CRO industry is preferred.
• Submissions document experience is advantageous.
• Experience in neurosciences is advantageous.
• Additional qualifications in medical writing (AMWA, EMWA, RAC) are advantageous.
• Experience in neurology, immunology, oncology, or vaccines would be valuable but is not essential.

Knowledge, skills, and abilities

• Significant knowledge of global, regional, national, and other document development guidelines.
• In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, or communications.
• 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 and a high degree of independence in decision making and problem solving.
• Ability to mentor and lead junior level staff.

Details of the role

The contract is full time. The work schedule is standard, Monday to Friday, and the environmental conditions are described as office. The role is remote. The employer says it is expanding its Medical Writing FSP Team in Europe.

What they offer

The employer describes an award-winning learning and development programme, a competitive salary, and an extensive benefits package based around health and well-being. It also cites a flexible working culture and a collaborative environment. The organisation describes itself as global with a local feel, with more than 100,000 colleagues and values of Integrity, Intensity, Innovation, and Involvement. The work sits under PPD clinical research services, part of Thermo Fisher Scientific, whose stated mission is to enable customers to make the world healthier, cleaner, and safer.

About the company

Lifelancer is a talent-hiring platform in life sciences, pharma, and IT, connecting talent with opportunities in pharma, biotech, health sciences, healthtech, and IT. The listing was originally posted on Himalayas and is curated by Lifelancer.