Sr Medical Writer

Sr. Medical Writer

• Specialist professional individual contributor with comprehensive knowledge in the area of Medical Writing.

• Ability to execute highly complex or specialized projects.

• Adapts precedent and may make significant departures from traditional approaches to develop solutions.

• May prepare responses regarding company products, drugs, or diseases and refers in-depth technical inquiries to medical personnel.

• Creates/updates technical documents for medium risk product international regulatory submissions (e.g., IVDR Class C/D and/or novel).

• Creates/updates technical documents for medium risk product domestic regulatory submissions (e.g., Class III and/or de novo).

• Prepares associated product labeling and clinical labeling (vial, kit labels), instructions for use and
  clinical brochures for high risk/high visibility products (e.g., IVDR Class C/D or US Class III, novel products, de novo products).

• Completes templated or untemplated verification and stability records for high risk/high visibility products.

• Interfaces with key stakeholders on tasks (e.g., Regulatory, Technical, Quality, Marketing, GSS, Assay Integration, Medical Affairs, Product Safety).

• Bachelor's Degree or Equivalent of work experience in related field and associate's degree

• Minimum 5 years of experience in similar role plus bachelor's degree (or equivalent years of work experience plus associate's degree) Bachelor's Degree preferred in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred

• Bachelor's Degree and 5 years or more of experience in similar role. Bachelor's Degree preferred in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred

• Requires knowledge of product areas and current developments.

• Current or former experience in Abbott is a plus.

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