What are the responsibilities and job description for the Senior Medical Writer - Remote position at Penfield Search Partners?
Contact: Alexandra Spink - No 3rd party candidatesJob 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 ResponsibilitiesAuthor 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 meetingParticipate 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 routinesMinimum Education, Knowledge, Skills, and AbilitiesPhD 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)
