Regulatory Medical Writer - Senior/Principal Level

Job OverviewJoin Connect Life Sciences, a reputable Clinical Research organization, as a Senior/Principal Regulatory Medical Writer. This role invites experienced professionals to leverage their expertise in regulatory writing while contributing to critical clinical research initiatives.Key ResponsibilitiesEvaluate, analyze, and interpret medical literature to identify key resources vital for study design and ensure statistical significance and scientific integrity.Write and edit a variety of clinical development documents, including but not limited to clinical protocols, investigator’s brochures, clinical study reports, informed consent forms, integrated safety and efficacy summaries, as well as presentations and publications for medical journals.Adhere to timelines and manage workflow efficiently, demonstrating flexibility in response to changes in project scope or deadlines.Deliver exceptional internal and external customer service, ensuring effective communication with clients to coordinate project elements.Take ownership of individual assignments, engaging proactively with project teams and relevant departments for information and guidance.Required SkillsOutstanding writing proficiency, with a strong emphasis on clarity and precision.Excellent organizational skills and the ability to manage multiple tasks simultaneously.Proficiency in MS Word, Excel, PowerPoint, and other relevant word processing tools.Strong understanding of scientific data and regulatory writing guidelines.Excellent communication capabilities for effective project coordination.QualificationsA minimum of 3 years of experience in the pharmaceutical industry or postdoctoral research in a relevant field.A Master’s or Ph.D. in a scientific, medical, or clinical discipline is preferred.Familiarity with federal regulations, Good Clinical Practices, and ICH guidelines is advantageous, along with experience in regulatory writing and client templates/style guides.Career Growth OpportunitiesThis position provides a platform for professional advancement, enabling Medical Writers to engage in diverse writing projects and develop a robust skill set in regulatory writing and industry standards.Company Culture And ValuesAt Connect Life Sciences, we uphold values of scientific rigor, critical thinking, and strong communication, cultivating a collaborative work environment that empowers Medical Writers to assume ownership of their work and effectively collaborate with team members.Employment Type: Full-Time