Otsuka is hiring : Senior Manager Medical Writing in Myrtle Point

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 contribute to the management of operational plans, budgets, and innovative solutions for all medical writing activities across OPDC. He / she will lead or contribute to process improvements to increase project efficiency, quality, and timely deliverables, and ensure the needs of the 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 attendance at team meetings, communication of document project status or risks / issues, and advising the asset team regarding MW activities, processes, and timelines.

Leads teams of writers for large multi-document projects (e.g., a regulatory submission), including resourcing, managing timelines, team coordination and collaboration, and issue management and escalation as needed.

Ensures MW activities meet quality standards and adhere to applicable corporate SOPs, work practices, 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 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 adequate coverage of MW tasks in line with company goals and objectives.

Manages and / or mentors contract MW staff. Activities may include 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 a highly matrixed 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, PowerPoint, Outlook, Teams)

Team player who demonstrates initiative, applies good judgment, and 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 (e.g., 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 responsibilities to meet business and organizational needs as necessary.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to protected status.

Company Benefits

Comprehensive medical, dental, vision, prescription drug coverage, company-provided basic life, accidental death and dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company-provided benefits.

For more information about Otsuka careers, visit the official career site.

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 best results for the organization.

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.

Application Deadline This will be posted for a minimum of 5 business days.

Company Benefits Comprehensive medical, dental, vision, prescription drug coverage, company-provided life insurance, disability, and other benefits as described above.

Otsuka is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

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