Principal Technical Writer (Medical Writer), Abbott Point of Care (Ottawa)

Job Description

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 130 years, we've 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, Canada

Status: Regular/Full Time

Position Overview:

This role is responsible for writing and overseeing the writing of clinical study documents including study specific protocols and reports, sections of regulatory submissions, clinical procedures and SOPs, and CAPA documents. Leads cross-functional teams, coaches and may supervise a team of documentation specialists and writers to meet documentation deliverables for the R&D Clinical Affairs Group. Manages multiple projects concurrently. Ensures on-time delivery of high-quality documentation that is compliant with the Quality System.

Responsibilities: ​

• Writes or oversees writing of study-specific clinical protocols and reports. Responsible for gaining cross-functional alignment on content of documents. Able to propose new or novel solutions to clarify complex content and able to reconcile differing views from a range of functional areas.
• Ensures the accuracy, consistency and completeness of data and information in reports and documentation. Able to access the sources of information or appropriate Subject Matter Experts needed to resolve issues. Interprets statistical study results and describes them appropriately in reports. Challenges conclusions when necessary.
• Manages and properly prioritizes documentation deliverables across multiple projects, assigns tasks to team members. Ensures communication with R&D, regulatory, quality, PMO and other necessary functional teams in order to achieve documentation deliverables. Maintains awareness of overall project timelines and deliverables.
• Writes or oversees writing of clinical processes, procedures, SOPs, forms, CAPA documents, and other documentation.
• Maintains consistency across clinical documentation; establishes style guides, templates, and best practice guidelines as needed.
• Ensures documents for clinical processes and procedures are in compliance with GCP, regulations, Quality System procedures, 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 and implements, or oversees implementation of, process improvements in the clinical writing and documentation activities.
• Supports and helps draft publications arising from clinical studies .
• Define and/or oversee formal literature searches to support regulatory activities and submissions, as required. Ensures reports with cited scientific publications are summarized clearly and concisely.
• Liaison with QA in the management and writing of clinical QRs in the CAPA process. Tracks QRs and ensures deadlines are met.
• The output provided by this role is subject to external audit (e.g. FDA, ISO). Lack of accuracy, compliance, and timeliness will impact the Quality system at site and division levels.
• Coaches junior staff.
• Provides updates to Senior management team as required.
• Uses industry and product knowledge to ensure documentation deliverables appropriately address the target audience.
• Identifies and communicates with potential clinical study sites and Key Opinion Leaders as required.
• Other tasks as required.

Required Education and Experience :
Bachelor’s degree (4 year program) in Science, Medical Technology, or similar technical field, or equivalent combination of education and experience. Additional certification in medical or technical writing is an asset.
Minimum of 6 years of relevant 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 with in vitro diagnostics (IVD) preferred. Supervisory experience desired.

Minimum of 2 years of 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 IVD, drug, or medical products.

Excellent written and oral communication skills with the ability to produce top quality, error-free and grammatically correct written work. Ability to interpret statistical study results.

Good decision making and interpersonal skills.

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

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.