Senior Manager Medical Writing

Job Summary

The Senior Manager, Medical Writing (MW) will be responsible for leading and advising on medical writing processes and activities for individual asset teams to which they are assigned. The Senior Manager, MW will additionally contribute to the management of operational plans, budgets, and innovative solutions for all medical writing activities across OPDC. He/she will also lead or contribute to process improvements intended to increase project efficiency, quality, and the timely achievement of deliverables, and ensure the needs of business are met, particularly in the preparation of accurate, timely, and multidisciplinary documents submitted to regulatory agencies worldwide. He/she may also lead teams of medical writers to collaboratively prepare regulatory submission dossiers and/or directly manage the activities of contract writers or other contract roles within the MW team.

Job Description

• Represents MW on project/asset teams, including but not limited to attendance at team meetings, communication of document project status or risks/issues, and acting as an advisor for the asset team regarding MW activities, processes, and timelines.

• Leads teams of writers for a large multi-document project (eg, a regulatory submission), including resourcing, managing timelines, team coordination and collaboration, and issue management and escalation, if needed.

• Ensures MW activities meet quality standards and expectations and adhere to applicable corporate SOPs, WPs, policies, guidelines, and regulations.

• Provides training and communications to internal and external stakeholders regarding MW processes, best practices, and process improvements.

• Reviews new ICH and FDA guidelines regarding MW, evaluates their impact on the organization and makes recommendations on the need to develop and/or enhance SOPs and work processes.

• Leads or supports process or innovation initiatives within the MW team and/or represents MW in other departmental innovation initiatives.

• Provides relevant and timely project information to the Head of Medical Writing, including budget recommendations, ensuring that adequate coverage of MW tasks is maintained in accordance with the company's goals and objectives.

• Manages and/or provides mentorship of contract MW staff. Activities may include, but are not limited to, interviewing, hiring, training, and timesheet/contract management.

• Authors and/or edits key clinical or regulatory documents, as needed.

Qualifications/ Required

• BA/BS degree in a Life Science discipline

• 8+ years of medical writing experience at pharma/biotech/CRO companies

• Excellent project management and communication skills.

• Ability to work with cross-functional teams in highly matrixed team environment, collaborate with a wide variety of team members and relate effectively to people at all levels of the organization

• Ability to proactively escalate issues and provide solutions to problems.

• Expertise in ICH and electronic submission guidelines for regulatory documents

• Demonstrated experience in writing/developing clinical and regulatory documents for global submissions

• Expertise with electronic document management systems and other content authoring technologies

• Ability to identify needed process improvements and contribute to their implementation.

• Embraces change and has a flexible and innovative mindset

• Experience with training and/or mentoring less experienced medical writers

• Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook, Teams)

• Team player who demonstrates initiative, applies good judgment, and consistently maintains a positive attitude

Preferred

• Graduate degree (MS, PhD) in a Life Science discipline

• Previous experience with managing/supervising other medical writers

• Member of a professional Regulatory or Medical Writing organization (eg, AMWA, DIA)

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change respon