Responsibilities:

•Serves as Medical Writing Lead on complex Oncology Early Development (OED) clinical regulatory documents, implementing all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and exUS).
•Leads clinical documents for regulatory submissions, including Investigator Brochures (IB), Protocols, DSURs, and Clinical Study Reports (CSR). 
•Assists in selection and supervision of freelance consultants or other vendors. Recognizes potential scheduling and resource conflicts for projects across assignments and provides recommendations to resolve.
•Accountable for meeting the main objectives of clinical writing projects inOncology Early Development within established timelines, budgets, and with an appropriate quality level.
•Provides project management or may oversee a project manager for writing projects for multiple compounds and/or indications within OED, including submissions, ensuring accuracy and adherence to timelines and processes.  As assigned, mentors and provides guidance to medical writers.
•Works directly with team members to develop/implement timelines to meet desired project completion dates.  Coordinates activities and communication with functional areas such as Statistics, Regulatory, Submission Operations, Pharmacokinetics, Medical Directors, and Safety Team on writing projects/submissions.  Effectively collaborates with clinicians and management utilizing cross-functional skills/expertise and drug development knowledge.
•Proficiently learns and applies therapeutic area and product knowledge to scientific projects. Develops expert knowledge of regulations, requirements, policies, and guidelines that apply to the preparation and production of clinical documents and ensures staff understands, complies, and applies them to work products.
•Ability to form, maintain, and lead productive cross-functional working/writing teams, including addressing issues that arise and effectively leading document adjudication with multiple stakeholders. Collaborative teamwork and leadership track record.  Implements systems or solutions to enhance efficiency, eliminate redundancy, reduce expenditure, and guarantee quality.
•Oversees writing projects to ensure timely completion.  Must resolve conflicts, remove barriers, and generate innovative ways to ensure teams achieve project goals.
•Knowledgeable about the product/disease state and is an expert on clinical documents.  Continually trains/be compliant with all current industry requirements as they relate to clinical regulatory submissions.