Clinical Research Medical Writer We 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. Responsibilities + Prepare 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 Skills + Clinical trial experience + Proficiency in medical writing + Knowledge of regulatory requirements for clinical studies + Strong writing skills requiring moderate to minimal editing + Strong software skills including Microsoft Office products and reference management software + Excellent time management and multi-tasking skills + Ability to analyze medical research data and review experimental protocols + 3+ years of industry experience Additional Skills & Qualifications + Experience in Infectious Disease and Clinical Research + Experience with IND and Regulatory reports + Ability to work with minimal supervision + Experience in Oncology therapeutic area is advantageous + Experience with medical devices is acceptable Work Environment This 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.