Senior Medical/ Technical Writer

Adecco is currently hiring a Senior Medical Writer/Senior Technical Writer for our Medical Device Manufacturing client in Ottawa West. This is a contract opportunity offering full time hours, Monday – Friday, with an option to work remotely. The salary for this position will be determined based on education and experience.

Our client is a diversified health care innovator with a legacy of pioneering work in medical diagnostics and devices. They are dedicated to advancing innovative with-patient diagnostic technology to improve patient care and system efficiency by fundamentally changing the way health care professionals process patients through their system.

Position Overview:

This role is responsible for writing and editing clinical documents including study specific protocols and reports, clinical procedures and SOPs, and CAPA documents. Works with cross-functional teams to achieve alignment on documentation deliverables. Delivers high-quality documentation that is compliant with the Quality System.

Responsibilities: 

  • Writes study-specific clinical protocols and reports.   Responsible for engaging appropriate subject matter experts and gaining cross-functional alignment on content of documents.
  • Verifies and assesses the accuracy, consistency and completeness of data and information in reports and documentation. Able to identify and access the sources of information needed to resolve issues.
  • Writes or oversees writing of clinical processes, procedures, SOPs, forms, CAPA documents, and other documentation as required.
  • Responsible for maintaining consistency across clinical documentation; writing and maintaining a glossary, style guide, and templates, as appropriate, for use by other team members.
  • Maintains documents for clinical processes and procedures and ensuring compliance with GCP, regulations, Quality System procedures, and Abbott corporate policies.
  • Identifies process improvements in the management and writing of clinical documents.
  • Supports and helps draft scientific publications arising from clinical studies, as required.
  • Defines and/or conducts formal literature searches to support clinical or other business activities. Summarizes scientific publications clearly and concisely, as required.
  • The output provided by this role is subject to external audit (e.g. FDA, ISO). The lack of accuracy, compliance, and timeliness will impact the Quality system at site and division levels.
  • Ensures close communication and working relationship with R&D, regulatory, quality, program management and other functional teams in order to achieve documentation deliverables. Maintains awareness of overall project timelines.
  • May provide supervision and mentorship to junior staff.
  • If hired remote, will travel to Ottawa/Princeton occasionally.
  • Required Education and Experience:

  • Bachelor’s degree (4 year program) in Science, Medical Technology, or similar technical field.
  • Additional certification in medical or technical writing is an asset.
  • Minimum of 3 years related work experience in Clinical Research or in a related field such as Product Development, Quality or Regulatory in a medical technology or healthcare industry.
  • Experience in in vitro diagnostics (IVD) preferred.
  • Experience writing, editing, and managing technical documentation utilized for clinical research, for IVD or medical device regulatory submissions or Quality System documentation, or for the development of new medical products.
  • Excellent written and oral communication skills with the ability to produce top quality, error-free and grammatically correct written work.
  • In-depth knowledge of software programs including Word and Adobe Pro, in Windows environment.
  • Ability to effectively work on multiple projects at the same time and to appropriately prioritize work.
  • Experience writing CAPA documents desirable. 
  • Knowledge of division products and Quality systems, system linkages and quality measures is desirable.
  • To be considered for the Senior Medical Writer/Senior Technical Writer opportunity, please Apply Now!

     

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    Reference number CA_EN_1_021956_1705407

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