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Clinical Medical Writer (Remote Opportunity)

Company: CareFusion 213, LLC
Location: Vernon Hills
Posted on: May 3, 2021

Job Description:

Job Description SummaryJob DescriptionBe part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.In Surgery, our products empower providers to reduce the incidence of surgical complications, improve patients' experiences and lower the total cost of surgical care.Reporting directly to the Manager or Associate Director of Medical Affairs, the Clinical Medical Writer researches and develops documents for the Surgery platforms that support the safety and efficacy of the platform's infection prevention, biosurgery, and advance reconstruction / hernia products. The Clinical Medical Writer performs literature searches, develops, writes, and edits non-clinical and clinical documents for regulatory submissions, manuscript publications, clinical study reports and study protocols, white papers, and other technical communications materials. This candidate works closely with Medical Affairs team members as well as cross-functional R&D, Global Clinical Development, Marketing, and Regulatory team members. Organization and preparation of documents should be prepared to set standards regarding order, clarity, conciseness, style and terminology.Job duties:Performs literature review and prepares preclinical/clinical/medical documents needed for regulatory submissions.Collaborates with other medical writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives. Responsible for ensuring that assigned plans and reports are self-checked for errors, grammar, accuracy, and that documents are routed accurately in the document control process.Attends meetings with New Product Development teams, RA specialists and International Business Center RA teams to create new or update existing regulatory documents. This will include critical review and incorporation of data from published, unpublished and historical clinical investigations.Organizes and incorporates information, such as references, graphics, tables, and data listings for the creation of large, clinical documents.Preparation of documents in accordance with procedures, internal and external guidelines, regulatory standards, guidelines and regulations.Collaborates with associates from Global Clinical Development (GCD) for writing clinical study protocols and study reports.Prepares manuscripts for peered reviewed publications. Prepares abstracts, slide presentations and poster presentations for scientific meetings within and outside the US.Interacts externally with lead authors, journals, conference organizers, and occasionally with freelance/contract medical writers.Is compliant and remains current with Good Publication PracticeEnsures that accurate, high-quality documents are prepared on schedule as per project timeline and workload demands.Remains current with medical developments and publications on similar and competitor products. Applies this knowledge in developing manuscript and interacting with lead authors.Other duties as assigned.Knowledge, Education and Skills:Bachelor's degree required; Advanced degree in Biological Sciences/Microbiology/Engineering preferred.A minimum of 4 years of proven ability in clinical medical writing with biopharma or medical device industry.This position requires demonstrated experience in high quality medical/technical writing and excellent written and oral communication skills.PMA/510K/PMA/ANDA/NDA process understanding required.Excellent understanding of scientific or clinical research and methods required.Influencing Skills - Able to establish rapport, value and respect within a complex and highly technical environment internally and externally. Able to influence directly and indirectly.Interpersonal Skills - Able to establish and build close working relationships across a highly matrixed organization and with alliance partners. Strong personal credibility, written and oral communication skills.Leadership Skills - Team oriented with the confidence, maturity and integrity to lead effectively. Self-directed with strong initiative; leads by example.Results and Action Oriented - Driven to excel and capable of encouraging others to excellence as well.Project coordination abilities - Manages multiple simultaneous projects. Excellent time management skills to prioritize projects based on landmarks and timelines. Works well in groups but also independently on managing projects.Willing to travel, ~ 10%: U.S., Canada and international.Must be able to speak and write English fluently; must be able to communicate clearly and accurately.Experienced in Microsoft Word, PowerPoint, Excel, and End NoteWhy join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day.You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates.To learn more about BD visit Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.#LI-PROPrimary Work LocationUSA IL - Vernon HillsAdditional LocationsWork Shift

Keywords: CareFusion 213, LLC, Arlington Heights , Clinical Medical Writer (Remote Opportunity), Other , Vernon Hills, Illinois

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