Specialist Disclosure Medical Writer
November 1
Description
• The Medical Writing & Disclosure Department prepares documentation in support of clinical development and compliance. • The Specialist will be primarily responsible for clinical study registration and results disclosure postings. • Preparing study registration and results postings based on source documents and guiding the posting through review and approval. • Collaborating with clinical teams to ensure compliance with legal requirements. • Responding to internal review comments on public disclosures. • Participating in weekly meetings and assuring Project Leads and management are informed. • Gaining expertise in regulations associated with disclosure of clinical study registrations and results.
Requirements
• Bachelor’s degree in Life Sciences or a related discipline. • Experience authoring protocol registrations and/or results disclosures on ClinicalTrials.gov or EudraCT. • Experience in authoring International Council for Harmonisation clinical/regulatory documents (i.e., Clinical Study Reports, Protocols, etc.). • Experience in technical or medical writing, familiarity with clinical research documents preferred. • Experience in medical publications or regulatory product labeling. • Good communication and interpersonal skills (both oral and written). • Strong attention to detail, strong analytical/logical thinking skills. • Able to abstract information from source documents. • High degree of organization and ability to manage simultaneous projects. • Demonstrated team skills, professional values, and personal skills necessary for effective teamwork. • Ability to work under pressure both independently and collaboratively in a team environment. • Familiarity with United States and/or European Union legislation for clinical trial registration and result disclosure.
Benefits
• bonus eligibility • long term incentive if applicable • health care and other insurance benefits (for employee and family) • retirement benefits • paid holidays • vacation • sick days
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