Senior Medical Writer at Otsuka Pharmaceutical
Senior Medical Writer
- The Medical Writer/Sr. Medical Writer is a writing-based position within our Global Regulatory Affairs department.
- He/she will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation.
- He/she will manage processes 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.
- Proactively manages writing activities across assigned projects as appropriate, ensuring adherence to the medical writing strategy and alignment with business needs.
- Contributes to therapeutic project teams as the medical writing expert for regulatory submission documents.
- Authors deliverables with consideration for regulatory, corporate, departmental, and quality standards (documents include but are not limited to protocols, clinical study reports, Investigator’s Brochures [IBs], annual reports, HA briefing packages and response documents, and integrated data summary reports).
- Adheres to Medical Writing practices/systems/tools to support clinical studies 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.
- Supports innovation initiatives within the Medical Writing Group
- Minimum of a BA/BS in Life Science; graduate degree preferred.
- 3-5 years pharmaceutical/biotechnology experience related to clinical research
- Demonstrated expertise in writing/developing clinical documents in support of regulatory submissions globally Ability to interpret and organize scientific and clinical data Medical writing experience in Pharma, Biotech and/or CRO
- Medical Writer:
- – BA/BS + 3 years; MS/PhD + 2 years
- Senior Medical Writer:
- – BA/BS + 7 years; MS/PhD + 4 years
- Experience with ICH and electronic submission guidelines for regulatory reports.
- Good leadership, communication, and influencing skills
- Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization. – Ability to manage change successfully and identify process improvements
- Applies good judgment and demonstrates initiative to resolve issues
- Excellent computer skills including MS Office (Word, Excel, PowerPoint, Outlook)
- Excellent written and verbal skills
- Ability to enact change and foster an innovative atmosphere
- Ability to function in an ambiguous environment
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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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