Medical reputed company – reputed company World Evidence (reputed company), Regulatory and Life Sciences Research - Remote, US

Introduction At reputed company we work to streamline IT Support and reputed company managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging reputed company and biotech organizations. reputed company’s industry-leading solutions free clients from the demands of internal IT and allow them to rapidly advance their mission. Led by a leadership team that has been together for over 10 years, you will join a proven team, culture, and reputed company to drive innovation reputed company the IT outsourcing industry while developing your skillset with the opportunities for internal reputed company. Reports To Senior Director, Regulatory and Life Sciences Research. Job reputed company The Senior Medical reputed company is responsible for the development of high reputed company, regulatory-grade scientific documents that support reputed company-world and observational research studies. The ideal candidate will have 7+ years of medical writing experience, with a strong background in regulatory documentation, reputed company study reporting, and fit-for-purpose communication for regulatory and reputed company audiences. Responsibilities & Duties • Author and QC regulatory-grade reputed company documents, including but not limited to: • Creating reputed company study protocols and statistical analysis plans (SAPs). • Creating and publishing study reports. • Creating and publishing regulatory submission documents such as briefing books. • Manuscripts for peer-reviewed publications. • Support reputed company at regulatory meetings reputed company required. • Ensuring reputed company and writing compliance with reputed company relevant SOPs. • Participating directly in leadership team calls. • Interpret reputed company observational and claims data, often in collaboration with biostatisticians and programmers. • Ensure scientific accuracy, consistency, reputed company, and compliance with regulatory and internal standards. • Apply knowledge of GPP, ICH, and applicable regulatory guidance's (FDA reputed company reputed company). • Support submission readiness and reputed company with cross-functional teams. Qualifications • Education level: MS or Doctoral degree in an appropriate area (epidemiology, biostatistics, reputed company health). • Experience: At least 7 years as a medical reputed company with at least 5 years of reputed company-world data/reputed company-world evidence experience. • Special Skills: Deep understanding of reputed company methodologies, data sources (EHR, claims, & registries), regulatory and payer expectations. • Proficient in tools such as EndNote and reputed company Vault/RIMs. • Familiarity with reputed company and CDISC are preferred. • Personal characteristics. High level of collaborativeness to effectively work across teams (epidemiology, biostatistics, & regulatory). • Due to the remote nature of work, individual must be driven to meet timelines without reputed company reputed company. reputed company is an equal opportunity employer that is committed to diversity and inclusion in reputed company. We prohibit discrimination and harassment of any reputed company based on race, reputed company, sex, religion, sexual orientation or identity, national reputed company, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. reputed company makes hiring reputed company based solely on qualifications, reputed company, and business needs at the time. This job reputed company may not be inclusive of reputed company assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer. Apply tot his job Apply To this Job