Principal Medical Writer (client-embedded) - EMEA
Principal Medical Writer (client-embedded) - EMEA
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob 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 lifechanging 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.
Summarized Purpose:
We are excited to be expanding our Medical Writing FSP Team in Europe. We are looking for a PMW 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 Principal Medical Writer to join our team. The Principal Medical Writer will 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 crossfunctional 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 highquality deliverables.
Manage multiple writing projects simultaneously and prioritize tasks effectively.
Stay current with industry trends guidelines and regulatory requirements.
Education and Experience:
Bachelors 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 system and AIdriven 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
Selfmotivated 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 awardwinning 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 wellbeing of our employees. We have a flexible working culture where PPD clinical research services truly value a worklife 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 100000 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.
Required Experience:
Staff IC
Employment Type
Full-Time
