Responsible for all medical writing activities within the oncology ADC therapeutic area (e.g. preparation of protocols, protocol amendments, clinical safety narratives, clinical study reports, investigator brochures, briefing books, CTD clinical Summaries, REMS, RMPs, and other clinical documents necessary for submission to US, European, Japanese and other global regulatory agencies). Accountable for high quality documents in terms of scientific content, organization, clarity, accuracy, format and consistency, and adherence to regulatory requirements and company guidelines/styles/processes. Ensure that all documents were appropriately staffed by internal MW employees and contractors and external writers, that DS procedures were followed, and that the documents met quality standards. Effectively manage stakeholders and influence across all levels of the organization and external collaborators. Work with senior Clinical and Regulatory staff in the US and Japan to ensure that the documents were produced in a timely manner, that regulatory requirements were met, and that the most effective procedures for preparing the documents for early approval were implemented. Lead continuing process improvement and effectively manage changes within and outside medical writing.
1. Provide leadership and strategic input to projects/study teams at the organization level; Plan and coordinate medical writing activities in the oncology ADC therapeutic area in collaboration with stakeholders within and across regions.
2. Make medical writer and outsourcing assignments to ADC projects and estimate resources needs, costs and timelines for document preparation; Ensure consistency within the ADC franchise
3. Provide strategic input and leadership to internal stakeholders including but not limited to the ADC franchise in all aspects of medical writing for in scope document; Manage conflicts effectively
4. Assess resources needs based on workload and project priorities and communicate in a timely fashion; Develop contingency plans to address the business needs based on current therapeutic area projects and anticipation of future therapeutic area projects
5. Represent Medical Writing on Global Medical Writing Committees; Liaise with Medical Writing Group in Japan to identify Medical Writing process improvement opportunities, potential collaborations and drive changes as needed etc.
6. Sourcing Strategy and Management of Outsourced Medical Writing; Provide strategic input on plans for outsourcing medical writing and collaborate with Outsourcing and Legal on CRO/niche CROs selection
7. Contributes to NDA/MAA submission strategy and development of submission timelines
8. Manage MWs, assess performance, productivity, and perform mid- and end-of-year performance review
Education and Experience
Minimum 7-10 years of experience with a Graduate Degree (Doctorate preferred) in a Biological or related science.
Regulatory Medical writing experience required
CTD submission preparation experience required