Clinical Research Medical Writer

Clinical Research Medical WriterWe are seeking a Clinical Research Medical Writer to join our team to assist with regulatory documents and FDA submissions. The role involves preparing scientific and regulatory documents for government and private sector clients for submission to the Food and Drug Administration (FDA). This includes Investigational New Drug applications, annual reports, preclinical and clinical study reports, safety reports, and investigator's brochures.ResponsibilitiesPrepare scientific and regulatory documents for submission to the FDA.Perform literature searches and prepare summaries of results.Prepare meeting reports and proceedings, safety documents, or data analysis.Contribute to technical proposals and respond to technical questions.Essential SkillsClinical trial experienceProficiency in medical writingKnowledge of regulatory requirements for clinical studiesStrong writing skills requiring moderate to minimal editingStrong software skills including Microsoft Office products and reference management softwareExcellent time management and multi-tasking skillsAbility to analyze medical research data and review experimental protocols3+ years of industry experienceAdditional Skills & QualificationsExperience in Infectious Disease and Clinical ResearchExperience with IND and Regulatory reportsAbility to work with minimal supervisionExperience in Oncology therapeutic area is advantageousExperience with medical devices is acceptableWork EnvironmentThis is a hybrid role, requiring three days of work from home and two days in the office. The in-office days will either be Tuesday and Thursday or Monday and Wednesday. This role offers the opportunity to join a government-sponsored Contract Research Organization (CRO) and gain experience writing in the Oncology therapeutic area.About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.