Benefits
- Commitment to work-life balance
- Disability insurance
- Floating leave days
- Insurance
- On-going training
- Paid leave
- Paid sick leave
- Performance bonuses
- Reimbursement for public transportation
Telecommuting
Technical Writers (Sr.)
FOP Experts Conseils inc.
202-9420 Boulevard Taschereau, Brossard,QC- Salary To be discussed
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37.50 to 40.0 h - Full time
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Contract ,Permanent ,Telecommuting job
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Day shift work
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Published since 11 day(s)
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3 positions to fill as soon as possible
Description
POSITION DESCRIPTION
KEY RESPONSIBILITIES
CANDIDATE PROFILE
WORK MODE
WHAT WE OFFER
Read more
FOP CONSULTANTS is looking for Technical Writers at the senior level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to draft and review GMP and technical documentation (SOPs, protocols, reports) in accordance with good documentation practices and to gather information from experts, manage versions and ensure the clarity, consistency and compliance of documents. The senior scope is further to define documentation standards and the site writing plan and to mentor intermediate writers and review their documents.
KEY RESPONSIBILITIES
- Draft procedures (SOPs), work instructions and GMP documents.
- Review protocols, validation reports and technical documents.
- Structure documentation in accordance with good documentation practices (GDP) and ALCOA+.
- Gather information from technical experts and operations.
- Manage versions, revisions and approvals in the document management system.
- Adapt content to users and translate as needed (French/English).
- Ensure terminological consistency and regulatory compliance of documents.
- Define documentation standards and the site writing plan.
- Mentor intermediate writers and review their documents.
- Lead the overhaul of the documentation system and its compliance.
CANDIDATE PROFILE
- Bachelor’s or Master’s degree in science, administration, literature, language or any other related discipline.
- Minimum ten (10) years of industry experience.
- Eight (08) to fifteen (15) years of experience as a Technical Writer.
- Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
- Tools and systems: MS Office suite, Adobe FrameMaker, MadCap Flare, Visio, Veeva Vault.
- Hold one of the following certifications: Technical writing certification, AMWA, GMP.
- The following are considered assets: RAC (RAPS), ASQ CQA, document management certification.
- Experience in Canadian public or private organizations.
- Language: French and English
WORK MODE
- Remote, Hybrid, On-site
WHAT WE OFFER
At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:
- Competitive compensation that reflects your expertise;
- Complete protection through our group insurance plans;
- Professional liability insurance so you can practise with confidence;
- Remote-work flexibility, based on client needs;
- 3 weeks of vacation to recharge;
- 3 paid sick days, to take care of yourself;
- A monthly allowance for your transportation costs;
- Real opportunities for advancement within the organization;
- Ongoing access to training to grow your skills.
Work environment
Equal Opportunity Employer
This employer is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans status, Aboriginal/Native American status or any other legally-protected factors. Disability-related accommodations are available on request for candidates taking part in all aspects of the selection process.
Requirements
Level of education
University
Diploma
BAC
Completed
Work experience (years)
10+ years
Written languages
Fr : Advanced
En : Intermediate
Spoken languages
Fr : Advanced
En : Intermediate
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