Medical Writer II

Spectraforce Technologies
United States, Illinois, North Chicago
Oct 25, 2024
Job Title: Medical Writer II Location: North Chicago, IL 60064 Duration: 12 Months Summarize the main purpose of the role: The company is seeking candidates for a position in regulatory submission writing. The main requirement is experience in regulatory submissions, specifically related to IVDR in the EU or FDA submissions in the US, such as PMA, BLA, or 510K submissions. Operational Details: The role is within the transfusion medicine organization, which deals with blood screening products. While specific product experience in blood screening isn't necessary, a background in in vitro diagnostics, medical devices, or pharmaceuticals is advantageous. Education: Bachelor's Degree In a relevant technical discipline, Communications, Marketing, English or equivalent, or an equivalent combination of education and work experience. Qualifications: Minimum 5 years English or Journalism field of study Exceptional writing and proofreading skills; Experience with AP Writing Style and AMA references; Multitasks, prioritizes and meets deadlines in a timely manner; Strong organizational and follow-up skills, as well as attention to detail Deep understanding of corporate branding structure. Must possess comprehensive written and verbal communication, interpersonal, presentation, analytical, project management skills and the ability to prioritize and handle a large volume of projects simultaneously and meet deadlines. Must be highly organized and attentive to detail. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 5%, including internationally. Progressively more responsible experience as a business or technical writer in a corporate sustainability, citizenship, or high technology (preferably biotechnology) environment.