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Protocol Labeling Strategist

4 months ago

Montréal QC, Canada The Staffing Exchange Inc. Full time

Are you ready to take your career to the next level in the exciting world of pharmaceutical regulatory sciences? Our esteemed company is seeking a highly skilled and motivated Protocol Labeling Strategist (Manager) to join our Global Regulatory Sciences team. This pivotal role reports directly to the Head of Protocol Labeling & Document Management and offers a hybrid work environment.
If you're a proactive leader with a passion for clinical regulatory affairs and medical writing, we invite you to apply and become a part of our innovative team driving global healthcare advancements.

As the Protocol Labeling Strategist (Manager), you will play a crucial role in our Protocol Labeling & Document Management group, overseeing the preparation and maintenance of documents accountable to Global Labeling Management (GLM). Your responsibilities will include managing Investigator’s Brochures (IBs), Single Reference Safety Documents (SRSDs), and Reference Safety Information (RSIs), among others. You'll also assist in reviewing and approving Investigator Initiation Packages (IIPs) while ensuring overall quality and timeliness of medical writing activities for GLM deliverables. Lead team meetings to develop and confirm document and regulatory strategies
Serve as the Subject Matter Expert (SME) for medical writing responsibilities
Provide guidance, lead/co-lead projects, and manage resources effectively
Drive document strategies collaboratively with project team subject matter experts
Verify accuracy of document content and ensure compliance with regulatory guidelines
Ensure deliverables conform to ICH and other regulatory guidelines
Perform Quality Control (QC) review, manage QC projects
Contribute to colleague training

Qualifications: Technical Skills:
Strong project management skills with a focus on Quality and Compliance while managing time-driven deliverables with competing priorities
Ability to work well in cross-functional teams and guide decision-making for document content strategy
Excellent written and oral communication skills in both English and French
Proficiency in medical terminology.
Interpretation and application of global and local regulatory requirements

Life sciences, Healthcare professional, pharmacy graduate, or equivalent
Advanced academic qualifications/degree an advantage

Fully bilingual (oral and written).
~5+ years of pharmaceutical regulatory or clinical experience (preferably 6 to 7 yrs.).
~ Hands-on pharmaceutical experience with content, medical writing, document development & maintenance in RA
~ Proven project management skills and methodologies
~