Principal Medical Writer - Client Embedded (FSP)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

Role Overview:

This role is a principal-level Asset Lead position dedicated to a client in the FSP space; experience in Structured Content Authoring systems and automation to support delivery would be preferred. This role is dedicated to supporting one or more therapeutic area assets. Asset Leads lead teams dedicated to delivering high-quality fit for purpose clinical documents including those for regulatory submissions, plan for efficient and accelerated ways of working, and contribute to key process improvements. This is a leadership and oversight role that involves substantial stakeholder management.

Essential Functions:

Strategic Planning and Oversight:

Develop and implement medical writing strategies for clinical project teams.

Ensure alignment of medical writing activities with overall project goals and timelines.

Document Development:

Oversee the creation, review, and finalization of clinical and regulatory documents (e.g., clinical study reports, protocols, investigator brochures, regulatory submissions and responses).

Ensure documents are scientifically accurate, clear, and comply with regulatory requirements and company standards.

Team Leadership and Management:

Lead and manage a team of medical writers, providing guidance, training, and performance feedback.

Coordinate with cross-functional teams (e.g., clinical, regulatory, biostatistics) to ensure effective communication and collaboration.

Quality Control and Compliance:

Implement quality control processes to ensure the accuracy and integrity of medical writing deliverables.

Ensure compliance with regulatory guidelines, industry standards, and internal policies.

Project Management:

Track and manage project timelines and deliverables, ensuring timely completion of all writing assignments.

Identify and resolve issues that may impact project timelines or quality.

Stakeholder Communication:

Serve as the primary point of contact for internal and external stakeholders regarding medical writing activities.

Present project updates and document status to senior management and project teams.

Regulatory Submissions and Support:

Support the preparation and submission of regulatory documents to health authorities.

Assist in responding to regulatory queries and providing necessary documentation.

Process Improvement:

Identify opportunities for process improvements and implement best practices in medical writing.

Develop and maintain standard operating procedures (SOPs) and templates.

Resource Allocation:

Allocate resources effectively to meet project needs and manage workload distribution.

Monitor and manage resource allocations throughout the product lifecycle.

Training and Development:

Provide training and mentorship to junior medical writers.

Stay updated on industry trends, regulatory changes, and best practices in medical writing.

Education and Experience:

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

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

Experience working in the pharmaceutical/CRO industry required.

Experience in clinical pharmacology and/or vaccines required.

Experience in managing and directing complex medical writing projects required.

EU CTR experience preferred.

Experience working on structured content management system 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, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.