Responsible for taking leadership in Medical Writing activities with high complexity for assigned Project. Responsible for preparing high-quality, strategic Clinical and Regulatory documents in assigned areas utilizing established templates and guidelines. Responsible to lead and foster subordinates with scientific/strategic knowledge and advanced level of expertise.
Position Core Competencies, Responsibilities and Accountabilities
As an experienced member of Project Team, leads the discussion and provides recommendation on Team’s decisions with rationale. Leads process improvement/cross functional activities and gives positive influence on function. Mentors and trains subordinates with scientific/strategic knowledge and advanced level of expertise.
1. Prepares and finalizes basic and complex clinical and regulatory documents (CSR, CTD for Clinical Parts, HA response document, IB*, briefing documents, Manuscript**) with higher level of independency.
- Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency.
- Documents must be prepared within established timelines.
- Document content must adhere to regulatory guidelines, or journal/authorship requirements and ethical publishing standards, as applicable; internal guidelines, styles; and electronic standards and guidelines.
*IB translation office is responsible for the process of IB translation.
**Publication coordinators are responsible for the process of preparation of materials for publication.
2. Takes a highly proactive or lead role on document preparation in terms of content by engaging scientific collaboration with clinical and other functional areas including global counter-part to ensure quality and accuracy of content.
3. Works collaboratively in a team environment and makes recommendations and decisions on assigned projects with respect to timing, scheduling, tracking, and strategy. Leads medical writers assigned to the same project to maximize the efficiency.
4. Contributes to standardize the efficient process for high quality document development. Be proactive in identifying opportunities for greater productivity and leads in finding and executing flexible solutions. Can lead cross-functional or wider activities for process/business improvement
5. Ensures contents of translated documents from scientific aspects.
6. Manages CRO for assigned Project and gives Instruction to Temporary staff for greater productivity
Contract and Budget control for CRO
Responsible for tasks/deliverables which ask to Temporary staff
7. Mentors and trains subordinates in MW dept. by providing guidance on document preparation, CRO management and other SME activities.
A PhD or equivalent in one of the biological sciences with 7 years of relevant pharmaceutical/scientific experience is required, or an MS or other advanced degree with 8-10 years relevant pharmaceutical/scientific experience.
A BS with 9-11 years of relevant pharmaceutical/scientific experience.
Janssen Pharmaceutical K.K. (7195)