お仕事情報

お仕事情報

開発薬事スペシャリスト:SS-3245HY

  • 女性が活躍
  • 英語を活かす

業界大手のグローバルCROと日本の老舗CROとの合弁会社

求人コード SS-3245HY
募集職種 開発薬事スペシャリスト
職務内容 • Reviews and provides technical advice to prepare regulatory submissions
• Provides regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products
• Provides project specific GRA strategy, technical expertise and co-ordination oversight for key client’s projects
• Ensures quality performance for key/managed projects
• Liaises with PPD globally to support global projects
• Serve as key clients “Executive” contact person for all issues including attendance at Regulatory Authority meetings and other Public Relation functions
• Manages project budgeting/forecasting to include creative input as to shifting of resources, allocations etc. to respond to a change in scope of personnel requirements to stay within project budget
• Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaise with C&PD to follow through on all aspects of contract modification
• Assists business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure with the client and BD
• Manages GRA team, whose primary objective is to deliver the day to day operational management of assigned GRA services
• Deputizes for GLT and functional manager in GRA as necessary
• Contributes to development & implementation of Global/regional function/plans
• Participates as required in project Launch Meetings, Review Meetings and Project Team meetings
• Establishes operating policies & procedures that affect departments and subordinate sections of work units. Interprets company-wide policies and procedures. Develops budgets, schedules, and performance standards.
応募要件 Required Education and Experience:
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’) or equivalent combination of education, training, & experience
• Proven leadership skills

Required Knowledge, Skills and Abilities:
• English language as well as local language where applicable
• Excellent interpersonal skills
• Familiar with computers and their applications, e.g. Word, Excel, PowerPoint
• Effective oral and written communication skills
• Excellent organizational and planning skills
• Good negotiation skills
• Ability to work on own initiative
• Proven ability to work effectively in a team environment
• Ability to motivate and integrate teams and teach/mentor team members
• Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures for Clinical Trial Authorization, licensing, lifecycle management
• Expert knowledge of ICH and other global regulatory guidelines
• In-depth knowledge in one of the specialist areas; preclinical, clinical, or CMC, etc
• Ability to discipline and reward employees and perform timely, effective performance evaluations
• Good judgment and decision-making skills
• Ability to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, etc)
• Knowledge of budgeting and forecasting
勤務地 東京、大阪、鹿児島
年収 600万円~1000万円
最終学歴 専門卒
推奨される資格要件 理系
その他

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