Senior Medical Writer

Description

Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer reviewed journals, Good understanding of global harmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities, demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a crossfunctional team, working knowledge of a document management system and basic knowledge of document publishing process, analyzed and interpreted complex data from a broad range of scientific disciplines.Coordinate and author regulatory documents (e.g. phase I/II clinical study reports, Investigators Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.When assigned as Lead Writer, ability to lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects.Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.Lead or colead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells. Able to collaborate with project team to respond to health authority questions, requests, etc.Provide departmental management with adequate information to help assess resource needs.