|Application Deadline||March 31, 2021|
|Experience Required||4 years|
MaxSys is currently looking for a Medical Writer for our client in the west end of Ottawa.
One year contract with chance of extension!!!
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
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:
*Please note, only qualified candidates will be contacted and the position could be filled prior to closing date. Thank you.*