Senior Medical Writing Lead for Clinical & Regulatory
Calico LLC
A biotech research company in South San Francisco seeks an Associate Director of Medical Writing to lead the development of high-quality clinical and regulatory documents. The ideal candidate must possess a Master's degree and over 8 years of experience in scientific writing at a biotech or pharmaceutical company. Responsibilities include document leadership, vendor management, and process improvement. A strong understanding of regulatory requirements and excellent communication skills are essential. The estimated salary range is $230,000 - $240,000 with additional bonuses. #J-18808-Ljbffr Calico LLC
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$306.1k - $382.6k
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$245k - $285k
...will be responsible for leading and managing the regulatory affairs within CMC function... ...assists corporate senior management in understanding... ...development and exposure to clinical regulatory strategy is highly... .... Track and report on Medical Writing and Regulatory Operations...SeniorMedicalRegulatoryContract work$250k - $286k
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...scientific rigor across early clinical development at Roche.... ...analyses, early regulatory engagements, and... ...that drive high-quality Medical Data Review (MDR) and... ...strategy.You independently lead statistical input into... ...in presentation and writing, with the ability to explain...SeniorMedicalRegulatoryFull timeInterim roleLocal area$141.7k - $263.1k
...Affairs & Access, U.S. Medical Affairs, cross-... ...) around data and regulatory milestones and... ...understanding of clinical data and regulatory... ...manner.Outstanding writing skills and proven... ...Significant experience in leading issues... ...influence and counsel senior leaders and teams...SeniorMedicalRegulatoryFull timeLocal area$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco... ...program(s) across the clinical development life-cycle and... ...supply chain, CMC, quality, regulatory, program & portfolio management... ...possess good scientific writing skills and good verbal skills...SeniorRegulatory
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