Job Description
At Thermo Fisher Scientific, you’ll find meaningful work that makes a global impact. Join our mission to enable customers to create a healthier, cleaner, and safer world. We equip our teams with the resources needed to achieve their career goals while advancing scientific research, development, and the delivery of life-changing therapies. With clinical trials in over 100 countries and ongoing development of innovative frameworks for clinical research, our work spans laboratory, digital, and decentralized trial services. Your commitment to quality and accuracy will enhance health outcomes for individuals and communities now and in the future.
Summarized Purpose:
We are excited to expand our India Medical Writing FSP Team! We are seeking a Principal Medical Writer dedicated to a client in the FSP space. Experience in immunology, oncology, or vaccines is valuable but not essential. As a Principal Medical Writer, you will deliver high-quality medical and scientific writing from planning through to final drafts for internal and external clients. You will lead document reviews for the team and provide training and guidance to junior members. As a subject matter expert, you will advise on document development strategies, regulations, and industry best practices, fostering effective communication for operational excellence.
Essential Functions:
Research, write, and edit clinical study reports and protocols, summarizing data from clinical studies.
Serve as the primary author for complex clinical and scientific 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, software use, regulatory requirements, and therapeutic knowledge.
Ensure compliance with quality processes and requirements for assigned documents, developing and reviewing best practices and leading process improvement initiatives.
Represent the department at project launch, review, and team meetings.
Education and Experience:
Bachelor's degree in a scientific discipline; advanced degree preferred.
8+ years of experience in a medical writing role.
Strong experience in authoring CSR, protocols, IBs, ICFs, and narratives.
Experience managing complex medical writing projects is required.
Preferred experience in the pharmaceutical/CRO industry, with submissions document experience advantageous.
Additional qualifications in medical writing (AMWA, EMWA, RAC) are a plus.
Knowledge, Skills, and Abilities:
Extensive knowledge of global and regional document development guidelines.
In-depth knowledge in specialty areas such as preclinical, therapeutic, regulatory, and communications.
Excellent medical writing skills, including grammar, editing, and proofreading.
Strong project management abilities.
Advanced interpersonal, oral, and written communication skills.
Exceptional negotiation and decision-making skills.
Ability to mentor and lead junior staff.
What We Offer:
At PPD Clinical Research Services, we hire the best, support each other’s growth, and value teamwork. You’ll benefit from an award-winning learning and development program designed to help you reach your potential.
We offer a competitive salary and an extensive benefits package focused on employee health and well-being. Our flexible work culture values work-life balance, fostering a collaborative environment where teams share expertise and enjoy working together.
Our mission is to enable our customers to make the world healthier, cleaner, and safer. As part of a global team of over 100,000 colleagues, we share core values of integrity, intensity, innovation, and involvement. Join us to accelerate research, tackle scientific challenges, drive innovation, and support those in need.
#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences and perspectives are valued.
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