Sr Scientific Editor/Writer
-Independently edit and write nonclinical reports and summary document sections. Provide guidance to junior editors.
-Write draft documents. Guidance may be needed when editing or writing more complex or unusual documents.
-Independently assess gaps in submission documentation, on the basis of regulatory requirements (eg, ICH M4, S9 versus M3). Independently propose solutions to address gaps.
-Identify which data are critical to a submission, and use these data (from source documents, such as study reports and articles) to generate summary documents. Present the data in the format best suited to the summary document (eg, create tables and draft new text as best suits a given set of data). Able to summarize data into succinct and informative text, without losing accuracy. Assist manager with resource allocation and planning.
-Act as project lead for nonclinical on projects of moderate scope (eg, IND). With guidance, lead more complex projects (eg, MAA).
-Review work of junior editors, and provide training when required, assisting with their professional development. Balance workload among a small group of editors, either to support own projects or to support the work of the group as a whole. May take on a supervisory role for editors, vendors, and contractors. May be responsible, with supervision, for performance management and development of employees (small number of individual contributors) with coach and counsel.
-independently to resolve issues and inform manager of resolution.
Bachelors degree w/6+ years pharma or related experience or PhD w/ 1-2years pharma or related experience. Experience with drug development, regulatory submissions, and MS/PhD preferred.
Takeda provides equal employment [and affirmative action] opportunities to minorities, females, veterans, and disabled individuals, as well as other protected groups.