A company is looking for a Principal Medical Writer to provide expert support in clinical and regulatory document preparation.
Key ResponsibilitiesGuide medical writing activities for key clinical and regulatory documents and submissionsLead the writing strategy, including organization, content, and timelinesServe as lead writer for important clinical and regulatory documents and responses to regulatory agenciesRequired QualificationsAdvanced degree in a relevant scientific / clinical / regulatory field preferred;
Bachelor's degree requiredAt least 7 years of experience writing clinical / regulatory documents in a pharmaceutical or biotechnology companyExperience as lead writer for key documents included in major US and / or international regulatory submissionsClear understanding of clinical development phases and regulatory processesKnowledge of FDA / international regulations and ICH guidelines related to document preparation
Principal Medical Writer
A company is looking for a Principal Medical Writer to provide expert support in clinical and regulatory document preparation. ...
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