Medical Writer

Acumed • Addison, TX

274d

About The Position

The Medical Writer conducts literature and clinical data searches, writes and evaluates medical and scientific content, and manages clinical evaluation reports and their process to ensure compliance with regulations and guidance documents as well as corporate and department policies and guidelines. S/he utilizes a working knowledge of Acumed and competitive products to evaluate the safety and effectiveness of Acumed products and serves as a subject matter expert on regulatory requirements of clinical data reporting as well as accessing available and relevant publications.

Requirements

• Bachelor's degree science, health or technical discipline required; advanced degree preferred.
• 2+ years of technical writing or technical editing experience
• 5+ years of scientific research experience
• Experience as author or contributor on peer-reviewed manuscripts preferred.
• Experience in medical devices (orthopedics preferred)
• Broad knowledge of medical/health information publications and sources, including online databases and reference materials
• Expertise in literature and database searching and retrieving.
• Solid understanding of Clinical Evaluation Reports and Clinical Evaluation Plans as defined by the current revision of MEDDEV2.7/1, EU MDR 2017/745, and other applicable regulatory guidelines and guidance documents.
• Working knowledge of 21 CFR part 820, ISO 13485, EU Medical Device Regulations, and other applicable medical device regulations and standards (e.g., ISO 14971)
• Demonstrates strong analytical, problem solving, and technical writing skills.
• Ability to work well with others, manage multiple projects simultaneously, and follow complex directions.
• Working knowledge of statistics, EndNote/reference manager, document control systems, and orthopedic devices
• Ability to read, write, and speak in English in order to read, understand, and complete all documentation and to communicate with team members and management.

Nice To Haves

• Experience in medical devices (orthopedics preferred)
• Experience as author or contributor on peer-reviewed manuscripts preferred.

Responsibilities

• Authors Clinical Evaluation Reports, Clinical Evaluation Plans, and other reports as assigned on Acumed products while ensuring compliance with applicable regulations, relevant guidance documents, and Company procedures.
• Develops and maintains knowledge of Company products and applies this knowledge to create thoroughly researched and well-written Clinical Evaluation Reports, Clinical Evaluation Plans, and other relevant reports.
• Conducts comprehensive literature and data searches of external and internal sources, including literature from journals, using Company systems and processes to support Clinical Evaluation Reports and other regulatory submissions.
• Develops individual Clinical Evaluation Report strategy and leads other Subject Matter Experts (SMEs) such as Product Engineers, Regulatory Specialists, and clinicians to ensure clinical data analyses are sound, accurate and meet regulatory requirements for new and legacy products.
• Manages correspondence with regulatory and standards agencies such as EU Notified Body as appropriate to gain clarification of requirements, respond to inquiries during review of submissions, and provide industry feedback.
• Identifies report requirements, obtains necessary information, and distills this information into detailed, accurate, concise and clear reports.
• Manages work including scheduling and use of external resources (e.g. consulting surgeons) engaged in performing research, analysis, writing, or review to be included in a Clinical Evaluation Report/Clinical Evaluation Plan per Company procedure.
• Develops Company procedure and strategy to ensure Clinical Evaluation Reports/Clinical Evaluation Plans meets regulatory requirements.
• Collaborates with Regulatory and Quality departments on regulatory submissions, risk analyses, and other reports which may be needed to meet post-market surveillance requirements (e.g. annual safety reports).
• Occasionally assists in the creation or review of relevant Marketing Communication and Medical Education materials.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree