Note: The job is a remote job and is open to candidates in USA. Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager for Combination Product Development. The role involves managing design history files, supporting technical dossier authoring for combination product projects, and facilitating risk assessments while ensuring adherence to regulatory standards.
Responsibilities
- Support the vision for the Device Development function
- Support a vision with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs
- Work with members of Device Development and Technology, and other functions including Packaging, Supply Chain, Clinical Supplies Operations, Quality Control, Regulatory and Quality Management to support strategies for product and process improvements
- Develop and support the strategic activities of the department
- Support appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration of all new products and life-cycle management products
- Evaluate new and innovative delivery device technologies to support new and life-cycle management projects
- Develop and perform the tactical activities
- Ensure efficient transfer of products and on-going product support all products to CMO’s from device perspective
- Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products
- Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work to develop device risk mitigation
- Create, maintain, and update device related documents required for regulatory filings and compliance
- Facilitate studies as required
- Write protocols, reports, specifications, procedures, change control requests, technical assessments, etc
- Program management of Device projects
- Develop project plans and corresponding project managements tools to support the execution of all projects
- Manage cross functional teams (including 3rd party resources)
- Execute Human Factors Engineering & Usability activities
Skills
- 5-8 years' experience in Pharmaceuticals, Medical Devices, Biotechnology, or other related industries
- In-depth understanding of device verification including functional testing, process validation/verification, quality assurance, and regulatory requirements as they pertain to and devices
- Ability to work strategically and independently with internal and external groups
- Demonstrated leadership skills especially the management of high-visibility project teams
- Demonstrated knowledge of parenteral delivery devices (syringes, self/ or auto-injectors), etc
- Self-Starter: ability to solicit & obtain time-sensitive information from various internal & external project stakeholders
- Effective communicator across all levels of the organization
- Able to deliver high level to detailed level status reports on programs, projects and portfolio information
- Utilizes experience, presentation and influencing skills to facilitate successful team discussions and outcomes
- Competency in use of business and project management computer software (such as MSProject and MSOffice)
- Experienced with usability testing / user studies / human factors
- Ability to operate effectively in a fast-moving dynamic environment
- Bachelor's degree in a related Engineering discipline (Mechanical, Electrical, Biomedical, etc.)
- Masters or advanced degree preferred
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
- Paid leave programs
- Other company provided benefits
Company Overview