Job Listings

MaxSys is currently looking for a Medical Writer for our client in the west end of Ottawa.
 
One year contract with chance of extension!!!
 
Qualifications:
 
Education:
• Secondary school diploma is required
• Undergraduate university Degree (4 year program), or equivalent experience (e.g.B.Sc., B. Eng) Science, mathematics, engineering or medical fields are preferred
Experience:
• Specify the nature of the experience.   (e.g. If 3 to 5 years of experience is required, this may include 2 to 3 years Clinical Research or Quality Assurance
• Typically requires 4+years of experience in a related area such as R&D, Technical Product Development, Quality, Regulatory Affairs, Clinical Research or Medical Writing to develop the competence to meet the skills and responsibilities of the position.
• Excellent written and oral communication
• Attention to detail; ability to find and correct errors in spelling, punctuation and grammar, consistency, clarify and accuracy.
• Strong interpersonal and team skills.
• Proficient in critically reviewing own work before sending out for internal/external review by team.
• Ability to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
• Ability to work independently and in groups; ability to work cross-functionally.
• Demonstrated initiative and problem-solving skills; critical-thinking skills.
• Ability to prioritize.
• High degree of competence in word processing, flow diagrams, spreadsheets, presentation software.
• Ability to motivate external team members to produce submission deliverables.
• Familiarity with timeline creation
Duties that may include, but not limited to:
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Serves as the Medical Writing representative on product teams.
• Coordinates all activities related to the preparation and compilation of data and information into a single comprehensive package for new and revised domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for diagnostic assays and instruments. 
• Communicates deliverables needed and writing process to team members. 
• Communicates timelines to team members.  Accesses resource needs as timelines progress, and communicates those needs to management. 
• Utilizes submission templates (if available) and format/style guidelines established by Medical Writing. 
• Obtains relevant product data and information.
• Assesses accuracy of information.  Understands sources of information. 
• Seeks out information to ensure complete documentation of all outputs. 
• Converts relevant product data and information into a form that meets submission requirements.
• Reviews, circulates edits, assembles, inspects, and duplicates product submissions.  Uses established documentation systems.
• Determines format for submissions and documents. 
• Interprets data, and verifies that results are consistent with protocols.
• Confirms completeness of information to be presented.  Challenges conclusions when necessary. 
• Confirms label and package insert claims are supported by and consistent with data presented in the submissions. 
• Acts as interface to resolve issues and questions arising during writing process. 
• Arranges and conducts review meetings with teams on submission and  related labeling. 
• Develops formats and presentations that enhance the ease with which the information can be understood. 
• Coordinates responses to inquiries, questions, and deficiencies received from submission reviewers both in the US and internationally. 
• Interprets and explains data generated from a variety of sources, including internal experiments, research documentation, charts, graphs, and tables. Explains the data in a manner consistent with the target audience and regulatory requirements.
• Develops consistent processes related to submission preparation, formats, and content. 
• Recommends and implements process improvements.  Leads process improvements. 
• Coaches and assists contract employees and more junior medical writers.  May also supervise the work of contract editors and medical writers.
• Takes a lead role in communicating their areas of expertise to department members. 
• Negotiates milestones and due dates based on anticipated product launch dates. 
• Other miscellaneous responsibilities as may be required.
 If you meet all the above requirements, please send your resume today to Katherine Spallin at: 
k.spallin@maxsys.ca 
 
*Please note, only qualified candidates will be contacted and the position could be filled prior to closing date. Thank you.*