Scientific Communications Medical Writer

Employment Type: External

Position Overview

Serving as a key link among essential functions, the Scientific Communications Medical Writer ensures the clear, precise, and accessible communication of critical information. By interpreting clinical study results and collaborating with healthcare professionals (e.g., study investigators, physicians, and key opinion leaders) and cross-functional teams within clinical research, regulatory affairs, research and development, and marketing, the medical writer will prepare journal manuscripts and conference materials (e.g., abstracts and presentations) to support product development and marketing efforts. Additionally, the medical writer may contribute to tracking medical writing documents, developing templates, and providing training for new staff members.

Specific Duties and Responsibilities

• 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.
• Develop and maintain strong relationships with academic institutions, physicians, KOLs, hospitals, and scientific societies/associations to facilitate 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.
• Attend relevant medical and scientific conferences to synthesize and disseminate summaries.
• 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.

Position Qualifications

Required Education and Experience:

• 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.

Additional Qualifications:

• 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 Microsoft Office 365.
• Familiarity with laws, regulations, standards, and guidance governing the conduct of clinical studies is a plus.

Working Conditions

• General office environment.
• Willingness and ability to work on site.
• May have business travel from 5% - 10%.
• Requires some lifting and moving of up to 15 pounds.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
• Must be able to move between buildings and floors within the office and access file cabinets.