Medical Writer, Disclosure

The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trials Operations creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials. Acquires and applies knowledge and understanding of medical writing responsibilities, including design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy). Demonstrates growing competence and independence in preparing clinical regulatory (e.g., clinical study reports, participant narratives, investigator’s brochures) and/or public-facing (e.g., clinical trial registration and results postings, plain language summaries, informed consent forms) documents per company and evolving regulatory requirements. Is a contributing member on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities. Collaborates and negotiates with internal and external stakeholders while planning, authoring, and leading the documents through review and final approval. Identifies & proposes solutions to challenges across the scope of work (e.g., documents, content, processes, timelines, tools). Keeps Project Leads and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance. Applies developing knowledge of clinical development, relevant regulations, disease areas, and company products. Applies developing knowledge of medical writing-specific tools and technology platforms. Participates in initiatives to improve medical writing processes and standards.

Required: Bachelor’s degree preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 2 years of relevant industry experience. Required skills & experience Knowledge of the principles of clinical research, clinical trial design, and fundamental statistics. Strong attention to detail, analytical/logical thinking skills, ability to critically evaluate and interpret data, and problem-solving capabilities. Ability to manage multiple projects in a deadline-driven environment, working both independently and collaboratively within cross-functional teams. Strong oral and written communication, interpersonal, and presentation skills in order to interact effectively and tactfully with stakeholders. Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology. Preferred skills & experience Familiarity with United States and/or European Union legislation for clinical trial registration and result disclosure and with clinical research documents (preferred). Technical or medical authoring experience with 1 or more of the following: Clinical regulatory documents (e.g., clinical study reports, protocols). Protocol registrations and/or results disclosures on public registries. Medical publications or regulatory product labeling. eligibleforERP clinicaltrialjobs Required Skills: Adaptability, Adaptability, Analytical Problem Solving, Business Software Applications, Clinical Research, Clinical Study Design, Clinical Trials, Clinical Trials Operations, Cross-Functional Project Management, Data Management, Deductive Reasoning, Ethical Standards, Evaluate Information, File Sharing, Knowledge Sharing, Logical Thinking, Medical Writing, Progress Monitoring, Project Leadership, Project Management, Project Management Leadership, Project Team Management, Project Tracking, Regulatory Compliance, Regulatory Writing {+ 7 more} Preferred Skills: