Thermo Fisher Scientific

Principal Regulatory Medical Writer (client-embedded) EMEA

United Kingdom

Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Regulatory AffairsIndustries

Position Overview

  • Location Type: [Not Specified]
  • Job Type: Full time
  • Work Schedule: Standard (Mon-Fri)
  • Environmental Conditions: Office
  • Company: Thermo Fisher Scientific (PPD clinical research portfolio)

At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

We are excited to be expanding our Medical Writing FSP Team in Europe. We are looking for a Principal Medical Writer to be dedicated to a client in the FSP space; experience in leading submissions would be preferred. We are seeking an experienced and highly skilled Regulatory Medical Writer to join our team. The role is to be responsible for creating, reviewing, and managing a wide range of clinical and regulatory documents. This role requires a strong understanding of scientific concepts, exceptional writing skills, and the ability to communicate complex information clearly and concisely.

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.

Education and Experience

  • Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred.
  • Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role (comparable to 8+ years).
  • Experience working in the pharmaceutical/CRO industry required.
  • Experience in managing and directing complex medical writing projects required.
  • EU CTR experience preferred.
  • Experience working on structured content management systems and AI-driven content creation, and familiarity with Natural Language Generation preferred.

Knowledge, Skills, and Abilities

  • 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
  • Capable of mentoring and leading junior level staff

What We Offer

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career.

Skills

Regulatory Medical Writing
Clinical and Regulatory Document Preparation
Clinical Study Reports
Protocols
Investigator Brochures
Regulatory Submissions (INDs, NDAs, MAAs)
Cross-functional Collaboration
Scientific Communication
Project Management

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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