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Scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation.
Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects.
Participates as part of the medical writing team in cross-functional teams.
Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in line with expectations.
Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings.
Works collaboratively with colleagues across functions to achieve results.
Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members.
Bachelor’s degree with 8+ years; or MS with 4+ years; or PhD with 3+ years of relevant career experience.
3-8 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry. Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
Participate actively in medical writing and cross-functional project teams.
Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.