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.
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