Director - Specialty Documents - Medical Writing

4 days ago

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Description

• Manage Medical Writing activities and deliverables for safety-related documents • Support authorship of informed consent forms and other submission documents • Manage clinical trial registries and facilitate SOPs/business processes

Requirements

• B.S./B.A. degree required, advanced degree highly desirable • Minimum of 10 years of relevant Medical Writing experience in the pharmaceutical industry • Preferred experience in clinical trial experience/clinical trial operations (3 years) • Understanding of the drug development process • Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines • Ability to identify, provide, and manage Medical Writing resources • Expertise in authoring and editing safety-related documents and ICFs • Familiar with document authoring and formatting tools • Expert in data sourcing, verification, and internal consistency • Familiar with authoring, editing, and reviewing SOPs • Proficient with Clinical Trials.gov • Excellent verbal and written communication skills • Ability to resolve and/or escalate complex issues • Excellent interpersonal relationship skills • Ability to interact with cross-functional study team members • Ability to contribute to determining realistic timelines • Excellent project management skills and attention to detail • Must read, write and speak fluent English

Benefits

• Unlimited paid time off • Parental leave • Medical insurance • Dental insurance • Vision insurance • 401k contribution