Senior Medical Writer - FSP
12 days ago
Richmond
Parexel is looking for a Senior Medical Writer located anywhere in the United States or Canada . Early Development/Translational Medical Writing experience required. The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals. Leadership Regulatory Document Authoring data summaries, and other regulatory documents on investigational drugs in various stages of clinical development of authoring process Complies with required training curriculum * Completes timesheets accurately as required * Submits expense reports as required * Updates CV as required * Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements * Focused writing and editing following defined processes and templates * Expert level authoring in MS Word, understanding of MS Word functionality, and works with Word add-ins that facilitate the management of fonts, styles, references, etc Participates in Medical Writing department initiatives, as appropriate. * Researches regulatory requirements to remain current in the regulatory landscape * Shares lessons learned and best practices * Ability to work independently * Ability to move across therapeutic areas to support business continuity and resource needs - Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion • Fluent in reading and writing American English Minimum 5 years in writing regulatory documents supporting global filings * Oncology and/or Infectious Disease/Vaccines experience * Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the EU and US Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements * Ability to interpret data and apply scientific knowledge to support regulatory document writing (i.e., IBs, protocols, amendments, CSRs, clinical summaries) as well as build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science with SCM and ability to author in an SCM environment using text libraries #LI-KW1 #LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.