Principal Medical Writer

7+ years

Not Disclosed

Remote, USA

10 Nov. 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Principal Medical Writer

Location: [Insert Location]
Job Type: Full-Time

Company Overview:

At Thermo Fisher Scientific, we are driven by our mission to enable our customers to make the world healthier, cleaner, and safer. By providing critical resources to advance research, development, and delivery of life-changing therapies, we empower our teams to achieve their career goals while contributing to the global health outcomes that people and communities depend on. With clinical trials across 100+ countries and ongoing development of innovative clinical research frameworks through our PPD clinical research portfolio, we are pushing the boundaries of scientific discovery. Your determination to deliver quality and accuracy will help improve health outcomes worldwide—now and in the future.

Job Overview:

We are expanding our India Medical Writing FSP Team and are looking for an experienced Principal Medical Writer to be dedicated to a client in the FSP space. While experience in Immunology, Oncology, or Vaccines would be advantageous, it is not essential. As a Principal Medical Writer, you will be responsible for producing high-quality medical and scientific documents, from planning through delivery. You will also serve as the lead writer, reviewing documents for the team, providing training, and guiding junior team members. As a subject matter expert, you'll offer advice on document development strategy, regulatory requirements, and industry best practices, ensuring operational excellence through effective and efficient communication with both internal and external clients.

Key Responsibilities:

Document Creation: Research, write, and edit clinical study reports, study protocols, and summaries of clinical study data.
Primary Author: Serve as the lead author for complex clinical and scientific documents, including Clinical Study Reports (CSRs), Investigational Brochures (IBs), Investigational New Drug Applications (INDs), and Market Authorization Applications (MAAs).
Review and Mentorship: Provide senior-level review of documents and offer guidance to junior medical writers. Train and mentor junior writers and program managers on document preparation, regulatory requirements, and therapeutic area knowledge.
Compliance & Best Practices: Ensure compliance with global quality processes and requirements for all assigned documents. Develop and review best practices, processes, and techniques for optimal document development.
Leadership & Collaboration: Represent the medical writing department in project launch meetings, review sessions, and project team meetings. Lead process improvement initiatives and assist with performance metric management for projects.

Education & Experience:

Required: Bachelor’s degree in a scientific discipline or equivalent; Advanced degree preferred.
Experience: 8+ years of experience in a medical writing role.
Technical Expertise: Strong experience in authoring CSRs, Protocols, IBs, Informed Consent Forms (ICFs), Narratives, and other clinical documents.
Leadership: Proven experience managing and directing complex medical writing projects.
Industry Knowledge: Experience in the pharmaceutical/CRO industry is preferred; submissions document experience is a plus.
Additional Qualifications: Certifications in medical writing (AMWA, EMWA, RAC) are advantageous.

Skills & Abilities:

Document Development: In-depth knowledge of global, regional, and national guidelines for document development.
Medical Writing Expertise: Strong editorial, grammatical, and proofreading skills, with excellent data interpretation and writing capabilities.
Project Management: Excellent project management skills with the ability to prioritize tasks and meet deadlines.
Interpersonal Skills: Advanced communication and presentation skills, with the ability to negotiate and collaborate effectively across teams.
Leadership: Ability to mentor and lead junior writers, providing guidance and fostering team development.
Judgment & Decision Making: Strong judgment, with a high degree of independence in decision making and problem-solving.

What We Offer:

At PPD, part of Thermo Fisher Scientific, we are committed to fostering your growth both professionally and personally. Our award-winning learning and development programs are designed to help you reach your full potential. We offer a competitive salary and an extensive benefits package that prioritizes the health and well-being of our employees. Enjoy a flexible working culture and work-life balance in a collaborative environment where we value teamwork, sharing expertise, and having fun together.

Our Mission:

We are united by a common purpose: to make the world healthier, cleaner, and safer. As a part of a global organization of over 100,000 colleagues, we share values of Integrity, Intensity, Innovation, and Involvement. Together, we accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. Join us at PPD, part of Thermo Fisher Scientific, and be a part of a diverse team where your experience and perspective are valued.

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Principal Medical Writer

Job Description

Job Title: Principal Medical Writer

Company Overview:

Job Overview:

Key Responsibilities:

Education & Experience:

Skills & Abilities:

What We Offer:

Our Mission:

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