Regulatory Medical Writer

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Develop and write Clinical Evaluations Plans and Reports for new and existing medical devices; Provides scientific/clinical expertise throughout the development and implementation of clinical evaluations and other risk management deliverables. Work with cross-functional teams and independent medical experts to develop clinical evaluation deliverables

Core Job Responsibilities

• Responsible for writing Clinical Evaluation Plans/Reports and other clinical deliverables by evaluating clinical evidence such as, clinical investigation, literature and post-market surveillance data
• Ensures quality by following procedures, work instructions and templates
• Drafts forms/templates for successful preparation of robust CERs and other documents
• Assists with other clinical, regulatory, quality and engineering projects as assigned
• Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management as directed
• Creates or manages timelines of deliverables
• Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature

Preferred Skills and Experience: 

• At least 3 years of regulatory, medical or scientific writing experience; CER writing experience preferred
• Excellent written and verbal communication skills. Experience in working with collaborative, cross-functional teams.
• Scientific/research background (i.e., has understanding of research design, methodology, and statistics)
• Excellent analytical skills

• Ability to manage complex tasks and manage time efficiently
• Proficient computer skills with Word, Excel, PowerPoint, Outlook, etc.
• Attention to details.

Minimum Education

• Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred.

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