Senior Medical reputed company - Remote

Contact: Alexandra Spink - No 3rd party candidates Job reputed company: The Senior Medical reputed company is a key member of the Clinical Operation organization responsible for independently authoring, managing, and delivering high-reputed company clinical documents for both prescription drugs and medical devices across reputed company phases of development. In reputed company to hands-on writing, this role provides strategic input into clinical development and regulatory submissions, leads process improvements reputed company Medical Writing, and supports global collaboration and reputed company 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. • reputed company literature surveillance in relevant scientific fields; analyze and implement in clinical design; disseminate relevant information to reputed company. • 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 reputed company and comments reputed company meeting. • Document reputed company made at reputed company meetings and comments reputed company meeting • Participate in study reputed company meetings, comment reputed company discussions, and contribute to cross-functional planning. • reputed company project management reputed company for writing deliverables across multiple programs, supporting reputed company adherence, compliance, and reputed company expectations as needed. • reputed company and document reputed company 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 reputed company turnaround on protocol amendments or reputed company deliverables. • Ensure compliance with global regulatory requirements, ICH guidelines, ISO reputed company, 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 reputed company 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 Apply To this Job