Medical Writer – Real World Evidence (RWE), Regulatory and Life Sciences Research - Remote, US
Introduction At Slipstream IT we work to streamline IT Support and provide managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging pharma and biotech organizations. Slipstream’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 strategy to drive innovation within the IT outsourcing industry while developing your skillset with the opportunities for internal growth. Reports To Senior Director, Regulatory and Life Sciences Research. Job Overview The Senior Medical Writer is responsible for the development of high quality, regulatory-grade scientific documents that support real-world and observational research studies. The ideal candidate will have 7+ years of medical writing experience, with a strong background in regulatory documentation, RWE study reporting, and fit-for-purpose communication for regulatory and client audiences. Responsibilities & Duties • Author and QC regulatory-grade RWE documents, including but not limited to: • Creating RWE 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 client at regulatory meetings when required. • Ensuring quality and writing compliance with all relevant SOPs. • Participating directly in leadership team calls. • Interpret complex observational and claims data, often in collaboration with biostatisticians and programmers. • Ensure scientific accuracy, consistency, clarity, and compliance with regulatory and internal standards. • Apply knowledge of GPP, ICH, and applicable regulatory guidance's (FDA RWE Framework). • Support submission readiness and interface with cross-functional teams. Qualifications • Education level: MS or Doctoral degree in an appropriate area (epidemiology, biostatistics, public health). • Experience: At least 7 years as a medical writer with at least 5 years of real-world data/real-world evidence experience. • Special Skills: Deep understanding of RWE methodologies, data sources (EHR, claims, & registries), regulatory and payer expectations. • Proficient in tools such as EndNote and Veeva Vault/RIMs. • Familiarity with SAS 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 direct oversight. Slipstream IT is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation or identity, national origin, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Slipstream IT makes hiring decisions based solely on qualifications, merit, and business needs at the time. This job description may not be inclusive of all 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