Senior Medical Writer - Remote
Contact: Alexandra Spink - No 3rd party candidates Job Summary: The Senior Medical Writer is a key member of the Clinical Operation organization responsible for independently authoring, managing, and delivering high-quality clinical documents for both prescription drugs and medical devices across all phases of development. In addition to hands-on writing, this role provides strategic input into clinical development and regulatory submissions, leads process improvements within Medical Writing, and supports global collaboration and onboarding where needed. Key Responsibilities • Author and manage the development of clinical and regulatory documents including protocols, protocol amendments, clinical study reports (CSRs), investigator brochures (IBs) / Reports of Prior Investigations (ROPIs), informed consent forms (ICFs), and labeling documents. • Compile clinical documentation to support regulatory submissions and responses to questions from health authorities. • Perform literature surveillance in relevant scientific fields; analyze and implement in clinical design; disseminate relevant information to the team. • Collaborate cross-functionally with Biostatistics, Clinical Operations, medical Experts, Regulatory Affairs, and other functions to ensure scientific accuracy. • Manage timelines for the development of clinical and regulatory documents including kickoff and comments resolution meeting. • Document decisions made at kickoff meetings and comments resolution meeting • Participate in study kickoff meetings, comment resolution discussions, and contribute to cross-functional planning. • Provide project management oversight for writing deliverables across multiple programs, supporting timeline adherence, compliance, and quality expectations as needed. • Perform and document quality control (QC) of internally and externally authored documents. • File clinical and regulatory documents, as applicable, in the study TMF. Serve as member of the inspection readiness team in preparation of a regulatory inspection. • Adapt quickly to urgent project needs, including rapid turnaround on protocol amendments or ad hoc deliverables. • Ensure compliance with global regulatory requirements, ICH guidelines, ISO standard, GCP standards, and company SOPs. • Participate in the development and improvement of working instructions and routines Minimum Education, Knowledge, Skills, and Abilities • PhD or PharmD in Life Sciences required, with a minimum of 5 years of relevant medical writing experience in clinical research. • Demonstrated expertise in the pharmaceutical industry, with proven experience developing documentation to support regulatory and clinical needs. • Extensive hands-on experience in authoring key clinical documents, particularly protocols and clinical study reports (CSRs). • Strong understanding of ICH guidelines, GCP, and global regulatory frameworks (FDA, EMA, NMPA). • Experience collaborating with cross-functional teams across multiple geographies and time zones (US, EU, China preferred); not expected to maintain availability outside of local working hours except for scheduled meetings. • Excellent written and verbal communication skills, with a proven ability to collaborate across diverse teams, influence without authority, and work independently and flexibly in a fast-paced, evolving environment. • Strong attention to detail and commitment to scientific rigor and regulatory compliance. • Fluent in English (written and oral) Apply tot his job