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Manager, Clinical Writing & Documentation, Abbott Point of Care (Ottawa/Remote) - Jobs in Ottawa, ON

Job LocationOttawa, ON
EducationNot Mentioned
SalaryNot Disclosed
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeFull Time

Job Description

At Abbott, were committed to helping you live your best possible life through the power of health. For more than 130 years, weve brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals - that create more possibilities for more people at all stages of life. Today, 109,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.Abbott Point of Care is a worldwide leader in providing with-patient care solutions that are intuitive, reliable, and cost-effective for our customers. By delivering lab-quality results in minutes, our i-STAT® System family of with-patient products and services fosters a collaborative, patient-centred environment while driving operational performance.We are headquartered in Princeton, New Jersey, with more than 1,500 global employees and a presence in 84 countries. Our 46,500 square metre manufacturing facility, Abbott Pointe, is located in Ottawa, Ontario, CanadaStatus: Regular/Full TimePosition Overview:In this role you will direct the Clinical Documentation and Technical Writing group to write consistent, professional clinical reports and other documents, manage document updates and CAPAs, and work cross-functionally across the clinical organization to implement best practices.Responsibilities:

  • Manage Clinical Technical Writing and Documentation team, consisting of technical writers and documentation specialists, including hiring and performance management.
  • Direct the writing of all clinical reports, aligning with statistics and program teams to ensure the reports meet all internal and regulatory requirements.
  • Implement consistent writing processes across all clinical documentation (develop style guides, best practice documents, training, etc).
  • Manage the documentation group to implement document changes, ensuring best practices and consistency within clinical documents. Responsible for tracking, and supporting the documentation of clinical CAPAs.
  • Based on in-depth knowledge of CLSI and FDA guidance, continue to improve clinical documentation processes to ensure compliance with emerging regulations.
Required Education and Experience:
  • Undergraduate university Degree (4 year program), Science, Engineering, Medicine or related. Higher degree (MSc, PhD, MD) preferred.
  • 10 plus years related experience in clinical research, quality, regulatory or R&D .
  • Skilled in technical writing for regulatory, quality or clinical functions.
  • Experience in In vitro diagnostics and knowledge of statistics is highly preferred.
  • Advanced Knowledge of: MS Office, particularly MS Word.
Abbott Canada is committed to the hiring, advancement and fair treatment of individuals without discrimination based on factors such as race, sex, colour, ethnic or national origin, religion, disability, age, citizenship, family or marital status, political beliefs, sexual preference or other factors included in human rights legislation.Our diversity goals for recruitment, hiring, and retention are embedded in our corporate goals, and our diversity initiatives are supported by the highest level of the organization.We strongly believe that a diverse workforce fosters more creative and innovative thinking throughout the organization. Creating an inclusive environment, where everyone is respected and valued, enables us to leverage our diversity as a business driver and strengthens our position as a global leader.Abbott strives to promote and maintain an inclusive, high-performing culture that allows all employees to reach their full potential and contribute to Abbott’s success.Join Our Talent Community to learn about upcoming job opportunities or connect with us at Abbott Canada, on LinkedIN, on Facebook and on Twitter @AbbottNews and @Abbott Global.Quick Apply
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