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Protocol Labeling Strategist

1 month ago

Montreal, 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.

Join Our Team: We offer a competitive salary range of $110K to $115K plus bonus and benefits. 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.

Role Summary: 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. Collaboration with stakeholders across various function lines and adherence to governing procedures and company SOPs will be key.

Responsibilities:

  • 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
  • Ensure documents are generated in accordance with internal processes and standards
  • Verify accuracy of document content and ensure compliance with regulatory guidelines
  • Ensure deliverables conform to ICH and other regulatory guidelines
  • Lead a team of internal or external authors as needed
  • Perform Quality Control (QC) review, manage QC projects
  • Contribute to colleague training

Qualifications: Technical Skills:

  • Proven leadership in leading global teams and fostering matrix team working relationships
  • 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
  • Demonstrated ability to influence and negotiate with diverse stakeholders
  • Sound decision-making and problem-solving skills
  • Understanding of external regulations and ability to assess implications and plan accordingly
  • Excellent written and oral communication skills in both English and French
  • Proficiency in medical terminology.
  • Interpretation and application of global and local regulatory requirements

Education:

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

Experience & Attributes:

  • Fully bilingual (oral and written).
  • 5+ years of pharmaceutical regulatory or clinical experience (preferably 6 to 7 yrs.).
  • Direct experience with IBs, SRSDs, RSIs, and IIPs
  • Hands-on pharmaceutical experience with content, medical writing, document development & maintenance in RA
  • Proven project management skills and methodologies
  • Knowledge of overall drug development process and experience with regulated deliverables
  • Understanding of ICH, CIOMS, and key market regulations and requirements.
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