PERMANENT Senior Technical Writer

  • Company:
    MaxSys
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    2 days ago
  • Category:
    Marketing

Status: Full time/Permanent

Position Overview: This role is responsible for writing and editing clinical documents including study specific protocols and reports, and clinical procedures and SOPs. Constructs or secures the necessary analyses of metrics including quality system linkage and recommendations utilizing statistical methods and database tools available. Provide awareness of data anomalies and performance contrary to goal objectives to management.

RESPONSIBILITIES:

Writes or oversees writing of study-specific clinical protocols and reports. Responsible for gaining cross-functional alignment on content of documents.
Writes or oversees writing of clinical processes, procedures, SOPs, forms and other documentation as required.
Responsible for maintaining consistency across clinical documentation; writing and maintaining a glossary and style guide for use by other team members
Maintaining documents for clinical processes and procedures and ensuring compliance with GCP, regulations and Abbott corporate policies.
Manages document update process; responsible for portfolio of clinical procedural documents and ensuring that current revisions are accurate and unambiguous.
Identifies, leads and implements process improvements in the management and writing of clinical documents.
Supports and helps draft publications arising from clinical studies.
Liaison with QA in the management and writing of clinical QRs in the CAPA process.
The output provided by this role is subject to external audit (e.g. FDA,ISO). The lack of accuracy and timeliness will impact the Quality system at site and division levels.
Ensure close communication and working relationship with R&D, regulatory, quality, PMO and other necessary functional teams
Provide supervision and mentorship to staff for their development and performance reviews
Provide updates to Senior management team as required

EDUCATION AND EXPERIENCE:

A University degree is preferred (Science, Medical Technology or equivalent technical degree) or equivalent experience.
3 to 6 years of related work experience is required.
Strong verbal communication and interpersonal skills
Relevant experience Clinical Research or in a related area such as Technical Product Development, Quality or Regulatory in a healthcare industry.
Relevant experience Clinical Research or in a related area such as Technical Product Development, Quality or Regulatory in a healthcare industry.
IVD experience is preferred.

If you are interested in this role, please contact

a.valencia@maxsys.ca

Only those who are qualified for the role will be contacted.

 
MAX112