Senior ICF Medical Writing Project Manager

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Thermo Fisher Scientific offers impactful work globally, enabling customers to improve health and safety. We have a vacancy for a Senior ICF Medical Writing Project Manager based in Mexico. Discover Impactful Work: Lead ambitious initiatives that craft the future of clinical research. Your expertise will enable us to deliver flawless Informed Consent Forms (ICFs) and other critical documents, ensuring outstanding quality and adherence to regulatory requirements. A Day in the Life: * Lead the development and maintenance of ICFs, ensuring accuracy, clarity, and compliance with all relevant regulations (e.g., FDA, EMA, ICH-GCP). * Manage multiple ICF projects simultaneously, from inception to final approval. * Collaborate with cross-functional teams, including medical writers, clinical research associates, regulatory affairs specialists, and project managers. * Ensure adherence to project timelines, budgets, and quality standards. * Review and revise ICFs and related documents for medical accuracy, clarity, and consistency. * Provide guidance and training to junior medical writers and project team members. * Stay up-to-date on the latest regulatory guidelines and industry best practices. * Participate in client meetings and presentations. * Identify and mitigate project risks. Keys to Success: Education: * Bachelor's degree in a scientific or related field (e.g., biology, chemistry, pharmacy) is required. * Advanced degree (Master's, PhD) is preferred. Experience: * Minimum of 5 years of experience in medical writing, with a focus on ICF development. * Proven experience managing ICF projects from start to finish. * Strong understanding of clinical research processes and regulations. * Experience working with international regulatory guidelines (e.g., FDA, EMA, ICH-GCP). * Experience working with electronic document management systems. Knowledge, Skills, Abilities: * Excellent written and verbal communication skills in English and Spanish. * Strong project management and organizational skills. * Ability to work independently and as part of a team. * Attention to detail and accuracy. * Ability to prioritize and manage multiple projects simultaneously. * Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). * Familiarity with medical terminology and clinical research concepts. * Excellent communication, interpersonal, and team collaboration skills. Benefits: We offer competitive remuneration, annual incentive bonus plan, healthcare, and a range of employee benefits. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.