Principal Medical Writer EMEA (client-embedded)

📌 Core Information

🔹 Job Title: Principal Medical Writer EMEA (client-embedded)

🔹 Company: Thermo Fisher Scientific

🔹 Location: Remote (EMEA)

🔹 Job Type: Full-Time

🔹 Category: Medical Writing

🔹 Date Posted: April 14, 2025

🔹 Experience Level: 10+ years

🔹 Remote Status: Fully Remote

🚀 Job Overview

Key aspects of this role include:

• Leading the development and writing of complex clinical and regulatory documents
• Collaborating with cross-functional teams to ensure timely completion and adherence to regulatory guidelines
• Mentoring and managing junior medical writers
• Staying current with industry trends, guidelines, and regulatory requirements
• Working with structured content management systems and AI-driven content creation

ASSUMPTION: This role requires a high level of independence, strong leadership skills, and the ability to manage multiple projects simultaneously.

📋 Key Responsibilities

✅ Lead the development, writing, and editing of complex clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions (e.g., INDs, NDAs, MAAs).

✅ Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to ensure the accurate and timely completion of documents.

✅ Ensure documents align with regulatory guidelines, company standards, and industry best practices.

✅ Provide strategic input and guidance on document content, structure, and presentation.

✅ Mentor and provide oversight to junior medical writers and ensure high-quality deliverables.

✅ Manage multiple writing projects simultaneously and prioritize tasks effectively.

✅ Stay current with industry trends, guidelines, and regulatory requirements.

ASSUMPTION: This role involves a high degree of independence in decision-making and problem-solving, as well as strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders.

🎯 Required Qualifications

Education: Bachelor's degree in a scientific field or equivalent and relevant formal academic/vocational qualification required; Advanced degree preferred.

Experience: 8+ years of regulatory writing experience in the pharmaceutical/CRO industry required. Experience working on structured content management systems and AI-driven content creation preferred.

Required Skills:

• Excellent organizational and program management skills
• Proven leadership skills to manage and mentor a team of medical writers
• Extensive knowledge of regulatory guidelines and drug development processes
• Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders
• Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards
• Self-motivated and adaptable
• Excellent judgment; high degree of independence in decision making and problem solving

Preferred Skills:

• Experience working in the pharmaceutical/CRO industry with a focus on EU CTR

ASSUMPTION: Candidates should have a strong scientific background and proven experience in regulatory writing, with a preference for those with experience in structured content management systems and AI-driven content creation.

💰 Compensation & Benefits

Salary Range: €80,000 - €120,000 per year (AI-estimated, based on industry standards for a Principal Medical Writer with 10+ years of experience in the EMEA region)

Benefits:

• Competitive Salary
• Extensive Benefits Package
• Flexible Working Culture
• Award-Winning Learning and Development Programme

Working Hours: Full-time (standard office hours, Monday-Friday)

ASSUMPTION: The salary range is an estimate based on industry standards for a Principal Medical Writer with the required experience level. Actual compensation may vary based on factors such as location, company size, and individual qualifications.

📌 Applicant Insights

🔍 Company Context

Industry: Thermo Fisher Scientific is a global biotechnology research company, serving science with a focus on enabling customers to make the world healthier, cleaner, and safer.

Company Size: 10,001+ employees (Enterprise-level)

Founded: 1956 (as a division of General Electric)

Company Description:

• Thermo Fisher Scientific is the world leader in serving science, with annual revenue of approximately $40 billion.
• The company offers a wide range of products and services, including analytical instruments, laboratory supply chain programs and eCommerce, laboratory equipment, lab services, specialty diagnostics, life sciences, pharma services, and CDMO.
• Thermo Fisher Scientific supports customers in accelerating life sciences research, solving complex analytical challenges, increasing productivity in laboratories, improving patient health through diagnostics, and developing and manufacturing life-changing therapies.

Company Specialties:

• Analytical Instruments
• Laboratory Supply Chain Programs and eCommerce
• Laboratory Equipment
• Lab Services
• Specialty Diagnostics
• Life Sciences
• Pharma Services
• Contract Development and Manufacturing Organization (CDMO)

Company Website: thermofisher.com

ASSUMPTION: As a large, global organization, Thermo Fisher Scientific offers a wide range of career opportunities and benefits, with a focus on serving science and making the world healthier, cleaner, and safer.

📊 Role Analysis

Career Level: Senior/Executive

Reporting Structure: This role may report directly to the Head of Medical Writing or a similar senior-level position within the organization.

Work Arrangement: Fully Remote (EMEA)

Growth Opportunities:

• Potential to mentor and lead junior medical writers
• Opportunities to work on high-profile, complex projects
• Possibility to advance to a leadership or management role within the medical writing department

ASSUMPTION: This role offers significant growth opportunities for experienced medical writers looking to advance their careers in a leadership capacity.

🌍 Location & Work Environment

Office Type: Remote (EMEA)

Office Location(s): EMEA region

Geographic Context:

• The EMEA region includes countries in Europe, the Middle East, and Africa.
• This role may require occasional travel to client sites or company offices within the EMEA region.
• The role offers a high degree of flexibility and work-life balance, with a focus on results and performance rather than face time.

Work Schedule: Full-time (standard office hours, Monday-Friday)

ASSUMPTION: The remote work arrangement for this role offers a high degree of flexibility and work-life balance, with a focus on results and performance rather than face time.

💼 Interview & Application Insights

Typical Process:

• Online application and resume screening
• Phone or video screening with the HR department
• Technical assessment or writing test
• Final interview with the hiring manager and/or other senior team members
• Background check and offer

Key Assessment Areas:

• Writing and editing skills
• Knowledge of regulatory guidelines and drug development processes
• Leadership and management skills
• Interpersonal and communication skills
• Problem-solving and decision-making abilities

Application Tips:

• Tailor your resume and cover letter to highlight your relevant experience and skills for this role.
• Provide specific examples of your writing and leadership experience, with a focus on complex projects and regulatory submissions.
• Demonstrate your understanding of the pharmaceutical/CRO industry and regulatory guidelines in your application materials.

ATS Keywords: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Regulatory Submissions, Medical Writing Leadership, Pharmaceutical Industry, CRO, EU CTR, Structured Content Management Systems, AI-Driven Content Creation

ASSUMPTION: The application process for this role is likely to be competitive, with a focus on candidates with strong writing and leadership skills, as well as relevant industry experience.

🛠️ Tools & Technologies

• Structured Content Authoring Systems
• AI-Driven Content Creation
• Natural Language Generation
• Regulatory submission software (e.g., eCTD)
• Project management tools (e.g., Microsoft Project, Asana, JIRA)

ASSUMPTION: This role requires experience with structured content management systems and AI-driven content creation, as well as familiarity with regulatory submission software and project management tools.

👔 Cultural Fit Considerations

Company Values:

• Integrity
• Intensity
• Innovation
• Involvement

Work Style:

• Collaborative and team-oriented
• Results-driven and performance-focused
• Adaptable and flexible
• Strong communication and interpersonal skills

Self-Assessment Questions:

• How do you ensure the accuracy and compliance of complex regulatory documents?
• Can you provide an example of a time when you successfully managed multiple writing projects simultaneously?
• How do you approach mentoring and leading junior medical writers to ensure high-quality deliverables?

ASSUMPTION: Thermo Fisher Scientific values candidates who are results-driven, collaborative, and adaptable, with strong communication and interpersonal skills.

⚠️ Potential Challenges

• Managing multiple writing projects simultaneously may require strong organizational and time management skills.
• Working remotely may present challenges in terms of communication and collaboration with team members and stakeholders.
• Occasional travel to client sites or company offices within the EMEA region may be required.
• The role may involve working with tight deadlines and high-pressure situations, requiring strong stress management skills.

ASSUMPTION: This role may present challenges in terms of project management, remote work, and occasional travel, as well as the need to work effectively under pressure.

📈 Similar Roles Comparison

• Compared to other medical writing roles, this position offers a higher level of responsibility and leadership, with a focus on managing multiple projects and mentoring junior writers.
• This role is specific to the pharmaceutical/CRO industry, with a focus on regulatory writing and structured content management systems.
• Career progression in this role may lead to leadership or management positions within the medical writing department.

ASSUMPTION: This role is unique in its focus on regulatory writing, structured content management systems, and AI-driven content creation, with a high degree of responsibility and leadership.

📝 Sample Projects

• Leading the development and writing of a complex clinical study report for a Phase III clinical trial
• Managing a team of medical writers to complete a regulatory submission for a new drug application (NDA)
• Collaborating with cross-functional teams to develop and review a comprehensive investigator brochure for a Phase II clinical trial

ASSUMPTION: These sample projects demonstrate the complex and high-level nature of the work required for this role, with a focus on regulatory writing and project management.

❓ Key Questions to Ask During Interview

• Can you describe the typical workload and project management expectations for this role?
• How does the company support the professional development and growth of medical writers within the organization?
• Can you provide an example of a time when the company successfully navigated a significant regulatory challenge or change in the industry?
• How does the company approach work-life balance and employee well-being, particularly for remote workers?
• What are the key priorities and goals for the medical writing department in the next 1-2 years?

ASSUMPTION: These interview questions are designed to provide insight into the day-to-day responsibilities, growth opportunities, and company culture for this role.

📌 Next Steps for Applicants

To apply for this position:

• Submit your application through this link
• Tailor your resume and cover letter to highlight your relevant experience and skills for this role, with a focus on complex projects and regulatory submissions.
• Prepare for a technical assessment or writing test, as well as interviews with the HR department and hiring manager.
• Follow up with the hiring manager one week after your final interview to express your continued interest in the position.

⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.