Job Title

·        Medical Writer

Position Description

• As a Lead Writer, will lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.

Position Responsibilities

• Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas and/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 co-lead (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

Position Requirements

• PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents.
• Provide departmental management with adequate information to help assess resource needs
• 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 pharmaceutical 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 cross-functional 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
• Author regulatory documents (e.g. phase I/II clinical study reports, Investigator’s Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.

Benefits

·        Blue Cross/Blue Shield Medical and Vision

·        Delta Dental

·        401K with Company Match

·        Holiday and Vacation Pay

·        Relocation Assistance