Protocol Labeling Strategist

2 weeks 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.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 strategiesServe as the Subject Matter Expert (SME) for medical writing responsibilitiesProvide guidance, lead/co-lead projects, and manage resources effectivelyDrive document strategies collaboratively with project team subject matter expertsEnsure documents are generated in accordance with internal processes and standardsVerify accuracy of document content and ensure compliance with regulatory guidelinesEnsure deliverables conform to ICH and other regulatory guidelinesLead a team of internal or external authors as neededPerform Quality Control (QC) review, manage QC projectsContribute to colleague trainingQualifications: Technical Skills:Proven leadership in leading global teams and fostering matrix team working relationshipsStrong project management skills with a focus on Quality and Compliance while managing time-driven deliverables with competing prioritiesAbility to work well in cross-functional teams and guide decision-making for document content strategyDemonstrated ability to influence and negotiate with diverse stakeholdersSound decision-making and problem-solving skillsUnderstanding of external regulations and ability to assess implications and plan accordinglyExcellent written and oral communication skills in both English and FrenchProficiency in medical terminology.Interpretation and application of global and local regulatory requirementsEducation:Life sciences, Healthcare professional, pharmacy graduate, or equivalentAdvanced academic qualifications/degree an advantageExperience & 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 IIPsHands-on pharmaceutical experience with content, medical writing, document development & maintenance in RA Proven project management skills and methodologiesKnowledge of overall drug development process and experience with regulated deliverablesBasic Pharmacovigilance knowledge desirableUnderstanding of ICH, CIOMS, and key market regulations and requirements.Apply Now

  • Protocol Labeling Strategist

    3 weeks 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...

  • Protocol Labeling Strategist

    3 weeks 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...

  • Protocol Labeling Strategist

    3 weeks 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...

  • Protocol Labeling Strategist

    3 weeks 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...

  • Protocol Labeling Strategist

    3 weeks ago

    montréal, 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...

  • Protocol Labeling Strategist

    3 weeks ago

    montréal, 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...

  • Protocol Labeling Strategist

    3 weeks ago

    Montréal, 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...

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