Job Description
Job Description: • Prepare high-quality abstracts and presentations for submission and presentation at conferences. • Engage in scientific writing and/or edit manuscripts for submission to peer-reviewed journals to achieve publication goals. • Ensure scientific communication deliverables are completed in a timely manner. • Evaluate data and translate information into succinct, scientific summaries. • Collaborate cross-functionally with clinical, marketing, and creative teams to ensure data dissemination goals and deadlines are met.
• Work with clinical study management and statistics teams to create timelines for completing data dissemination plans related to clinical studies. • Strong communication with physician authors to achieve deliverables, maintain relationships, and to facilitate overall scientific communication efforts. • Contribute to the preparation of clinical data for analysis and scientific writing. • Conduct literature searches for relevant disease states and maintain the clinical literature library. • Lead cross-functional project reviews and serve as a core team member and subject matter expert on clinical study teams to create timelines for completing medical writing documents.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * • Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * • Ensure other members of the department follow the QMS, regulations, standards, and procedures. * • Perform other work-related duties as assigned.* Indicates an essential function of the role Requirements: • Advanced degree (Master’s, PhD, or MD) with 2+ years of experience as a medical writer in the medical device, biotech, or pharmaceutical industry; or 5+ years of experience as a medical writer in clinical/scientific research, or an equivalent combination of education and experience.
• Experience as a medical writer for cardiovascular clinical trials in the medical device, biotech, or pharmaceutical industries is preferred. • Demonstrates a diligent approach to work, with a portfolio that showcases outstanding writing skills and a passion for clarity in written expression. • Team player with excellent organizational skills and the ability to prioritize assignments and manage multiple projects simultaneously, both independently and collaboratively. • Proficient in bolthires Office 365.
• Familiarity with laws, regulations, standards, and guidance governing the conduct of clinical studies a plus. Benefits: • A collaborative teamwork environment where learning is constant, and performance is rewarded. • The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases. • A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
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