Medical Writer

Responsibilities:

• Coordinate and 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.
• 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 co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells.

Required Qualifications:

• 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.
• In addition, 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.