Job Description

**General Description:** The Senior Medical Writer is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical regulatory documents include, but are not limited to study reports, clinical study protocols or amendments, investigator brochures, and clinical sections of INDs, NDAs, MAAs and other regulatory submission documents. **Essential Functions of the job:** + Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents. + Responsible for ensuring that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles. + Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables. + Review and edit documents, including those authored by others both internally and externally. + Collaborate within the medical writing group to develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates, style guide, etc.) + Ensure clinical documents adhere to BeOne standards and regulatory guidelines. + Coordinate and manage contract medical writers as needed. **Qualifications:** Knowledge and Skills + 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. Supervisory Responsibilities: + N/A Computer Skills: + Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and PowerPoint. Education/Experience Required: + At a minimum 4 years' relevant industry experience as a regulatory medical writer with a BA/BS degree; PhD/PharmD in life sciences preferred. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Tags

Contract work, Shift work,

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