Senior Manager - Medical Writing

September 16

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501 - 1000

Description

• The Senior Manager, Medical Writing is responsible for writing, editing, and formatting clinical regulatory documents • Responsible for mentoring junior medical writers and managing direct reports • Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines • Ensures clinical documents adhere to BeiGene standards and regulatory guidelines • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables

Requirements

• Demonstrated ability to communicate and write English clearly, concisely, and effectively • Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands • Independently motivated with good problem-solving ability • Excellent interpersonal skills; a team player • Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member • Strong project management skills • Recent and significant experience in writing of regulatory documents such as clinical study reports, protocols, and protocol amendments • Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines • Experience in writing clinical sections of INDs, MAAs, and NDAs is a plus • The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents • Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred • Ability to comply with company and/or industry style guides and templates • Excellent attention to detail related to consistency, grammar, syntax, and scientific accuracy • Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and PowerPoint

Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness