Senior Manager Medical Writing

* 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.* 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* 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)**Competencies**

**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.

**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

**Respectful Collaboration -** Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

**Empowered Development -** Play an active role in professional development as a business imperative.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 responsibilities to meet business and organizational needs as necessary.If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.

You can request reasonable accommodations by contacting Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. #J-18808-Ljbffr