Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com
OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/
The Medical Writing 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.
- Minimum of a BA/BS in Life Science.
- 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
- 3+ years medical writing experience in Pharma, Biotech and/or CRO, necessary
- 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, Power Point, Outlook)
- Excellent written and verbal skills
- Ability to enact change and foster an innovative atmosphere