[Innovative Medicine] R&D, Manager, Japan Medical Writing, Regulatory Medical Writing, Global Develo

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Job Function:
Medical Affairs Group

Job Sub Function:
Medical Writing

Job Category:
Professional

All Job Posting Locations:
Chiyoda, Tokyo, Japan, Chiyoda-ku, Tokyo, Japan

Job Description:

Position Summary:

• Able to write and coordinate basic and complex documents independently within and across therapeutic areas (TAs).

• Leads in a team environment and matrix.

• Able to function independently as a lead writer on any compound.

May consult with more senior colleagues on complex situations.

• Leads discussions in or leads process working groups.

• May lead and actively participate in setting functional tactics/strategy.

• Initiates or provides input into TA-level strategy (eg, submission team, global program team, clinical team).

• Able to oversee the work of external contractors.

Principal Responsibilities:

• Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.

• Leads or sets objectives for others on team projects and tasks, eg, leading process working groups or Communities of Practice.

• Guides or trains cross-functional team members on processes, best practices; coaches or mentors more junior writers.

• Able to function as a lead writer on any compound (or submissions, indications, or disease areas): is primary point of contact for medical writing activities for the cross-functional team (eg, clinical), with support as needed from more senior colleagues on complex situations with cross-functional teams.

• Leads cross-functional (eg, with clinical team) document planning and review meetings.

Interacts with cross-functional colleagues on document content and champions MW processes and best practices.

Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.

• Proactively provides recommendations for departmental process improvements.

• Completes all time reporting, training, and metrics database updates as required in relevant company systems.

• Coaches or mentors more junior ...