Job Description

　　Summary:

　　In addition to document preparation, provides training to other Scientific Technical Writers related to technical documents for the preparation of Annual Product Reviews (APRs) and Annual Stability Reports (ASRs) including compilation, statistical trending and assessment of critical production and product performance data.

　　Essential Functions:

　　 Prepare Technical documents and change controls as needed

　　 Prepare APRs using technical documents such as ASRs, CPVs, MBRs and other sources

　　 Attend client meetings related to regulatory filings, technical document requirements, issues and change controls as required.

　　 Work with clients to address issues related to Annual Product Reviews to complete reports in a timely manner.

　　 Provide training and technical expertise to other Scientific Writers.

　　 Maintain a safe working environment and report potential hazards.

　　 Perform alternating or rotating shift work (as required)

　　REQUIRED QUALIFICATIONS

　　Education:

　　College Diploma in Science/Technical related field (Food or Drug)

　　B.Sc. an asset.

　　Experience:

　　Minimum 3 year experience in preparation with APRs, ASRs and other Technical Documents

　　Experience in TrackWise

　　Experience in SAP

　　Experience in MS Office including Microsoft Word, Excel and Access.

　　Experience with Statistical Software Minitab an asset

　　Experience with Adobe Pro an asset

　　Equivalency:

　　Equivalent combinations of education, training, and relevant work experience may be considered.

　　Knowledge, Skills and Abilities:

　　Good written and oral communication skills. Well organized and detail oriented. Knowledge of Good Manufacturing Practices and ability to follow Standard Operating Procedures (SOPs). Ability to work under pressure and meet tight deadlines. Experience in managing multiple priorities. Self motivated and able to work independently. Understanding of Regulatory requirements including USP/NF and Ph. Eur. Intermediate Level Microsoft Office applications. Proficiency with the English Language.

　　Standards and Expectations: 

　　Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.  Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual

　　management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system Scientific Technical Writer II -

　　improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner.  Consistently strives to improve skills and knowledge in related field.

　　Physical Requirements:

　　Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust,

　　fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

　　Disclaimer:

　　This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Nothing contained herein should be construed to create an employment contract. Occasionally, required

　　skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.