- Masters or Doctoral degree or equivalent in a medical/scientific discipline preferred.
- 8+ years of clinical research experience with 3+ years of experience in the development & management of a medical writing function and direct management of staff in a pharmaceutical and/or biotechnology environment. Oncology experience required.
- Experience with writing and leading deliverables for global clinical trials and regulatory submissions.
- Experience of direct management of staff in a pharmaceutical and/or biotechnology environment.
- Experience partnering and managing CRO relationships and other external resources.
- Proven excellence in operational strategy and demonstrated ability to execute operationally.
- Excellent communication, planning and organizational skills.
- Ability to inspire, to lead-by-example and motivate the team to seek solutions and get results.
Other Skills and Abilities:
- Drives results
- Strategic mindset
- Manages ambiguity and complexity
- Optimizes Work Processes
- Attracts and develops top talent
- Effective oral and written communication skills required.
- Teamwork and interpersonal skills required.
- Highly detail and quality oriented.
- Must be able to travel domestically and internationally. Domestic and international travel includes spending time at cancer trial sites/institutions, conference centers, offices and hotels.
- Ability to review and present information effectively to internal and external clients, both domestic and international.
- Good working knowledge of medical/scientific terminology and knowledge of ICH guidelines and regulations related to data management activities.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret abstract and concrete concepts.
- Solid PC skills including Medical Writing software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint (and any additional software packages utilized at Taiho).
- While performing the duties of this job, the employee is frequently required to sit, talk and hear.
- The employee is occasionally required to walk.
- The employee must utilize close vision and be able to adjust focus.
- The noise level in the work environment is usually quiet.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The incumbent in this position may be required to perform other duties, as assigned.