The Sr. Manager, Medical Writing role will be responsible for managing in-house and/or contract medical writers, leading and advising on medical writing strategies for individual project teams, and contributing to the management of operational plans and innovative solutions for all medical writing activities across OPDC.
Proactively manages writing activities across diverse therapeutic programs, applying knowledge and experience while ensuring adherence to the medical writing strategy and alignment with business needs.
Contributes to therapeutic project teams as the medical writing expert for clinical and regulatory submission documents and, where applicable, authors deliverables with consideration for regulatory, corporate, departmental, and quality standards.
Manages and provides mentorship of in-house and/or contract Medical Writing Staff.
Authors/edits regulatory submission documents, or reviews deliverables produced by team with consideration for regulatory, corporate, departmental, and quality standards (documents include but are not limited to clinical study reports, Investigator's Brochures [IBs], annual reports, briefing packages, and integrated data summary reports).
Adheres to the global Medical Writing team's practices and utilizes the systems and tools available to support document development in order to meet company goals and objectives. Assures that standardized practices are implemented and maintained across all therapeutic areas.
Engages with team members to ensure medical writing continues to deliver value to the business.
Ensures medical writing activities meet quality standards and expectations and adhere to applicable corporate SOPs, WPs, policies, guidelines and regulations.
Provides training and communications to internal stakeholders and providers regarding medical writing process, best practices and process improvements.
Reviews new ICH and FDA guidelines regarding medical writing, evaluates their impact on the organization and makes recommendations on the need to develop and /or enhance SOPs and work processes.
Supports innovation initiatives within the Medical Writing Group and/or represents Medical Writing in other departmental innovation initiatives.
Job Responsibilities:
Manages and provides mentorship of in-house and/or contract Medical Writing Staff.
Authors and/or edits key regulatory documents as needed, including but not limited to clinical study reports, Investigator's brochures, annual reports, briefing packages, and integrated data reports.
Reviews Medical Writing deliverables against quality and in-house standards. Manages the quality control (QC) review of published and non-published deliverables
Represents Medical Writing on project teams, including but not limited to attendance at team meetings, communication of project status and critical path issues, and provision of dates to project management team for input into the clinical trial management system (IMPACT).
Provides project management services for Medical Writing projects, including timeline management, budget recommendations, issue resolutions, among other tasks.
Provides relevant and timely project information to the Head of Medical Writing, ensuring that adequate coverage of medical writing needs is maintained in accordance with the company's goals and objectives.
Adheres to and helps maintain departmental SOPs and working practices, including the necessary model documents and style guidelines, for standardized processes and style expectations across projects.
Mentors and trains external writing staff and other departments on Medical Writing tools and/or business processes.
Provides backup support for other Medical Writing Staff.
Qualifications/ Required
Knowledge/ Experience and Skills:
At least 8 years pharmaceutical/biotechnology experience. 6+ years medical writing experience in Pharma, Biotech and/or CRO.
Demonstrated expertise in writing/developing clinical documents in support of regulatory submissions globally.
Ability to interpret and organize scientific and clinical data.
Previous supervisory or mentorship experience preferred.
Excellent project management and communication skills.
Ability to work with cross-functional teams in highly matrixed team environment, collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization.
Ability to identify process improvements and contribute to their implementation.
Ability to proactively escalate issues and provide solutions to problems.
Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook)
Excellent written and verbal skills.
Embraces change and has a flexible and innovative mindset.
Educational Qualifications:
BA/BS in Life Science with a Masters degree strongly preferred.
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 their protected veteran or disabled status, or any protected status.
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.
Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
Application Deadline : This will be posted for a minimum of 5 business days.
Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & 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.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka .
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.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration 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.
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 Accommodation Request (EEAccommodations@otsuka-us.com) .
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