VP Clinical Operations - RoW
Our client, Alvogen is one of the world's leading generic pharmaceutical companies with a footprint in 45 countries, a turnover exceeding 1 billion US dollars and over 3000 ambitious professionals. The company’s portfolio is based on a combination of complex generics, leading proprietary products, OTC, Biosimilars and Hospital products.
For more information visit: www.alvogen.com.
The VP Clinical Operations RoW reports directly to the Executive Vice President Global Strategic Portfolio and will build strategy development and coordinate clinical activities as well as building and maintaining submission strategy in the clinical part of the projects.
Location of this employment is flexible; we will consider especially candidates situated anywhere within Europe.
• Work closely with Regulatory function to identify the clinical requirements.
• Analyze information collected by the Clinical team and present to senior management.
• Review study protocols, clinical expert reports and any other documents requested for the registration purposes.
• Support regulatory authority applications and approvals.
• Maintains effective written and verbal communication throughout the company and with clients, including producing required reports, forms, manuals and other required information. Meets regularly with facility administrators, clinical staff, referral sources and business contacts.
• Investigates and resolves problems as they occur.
• Directs, manages and advises all department managers in direct relation to job performance, career advancement and day to day operations.
• Prepares and administers department budget, oversees the management of expenditures and annual inventories.
• Previous experience in leading clinical department in pharmaceutical area.
• Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to write speeches and articles for publication that conform to prescribed style and format.
• Ability to effectively present information to top management, public groups, and/or boards of directors.
• General knowledge of Clinical Development process; strong knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and other related documents.
• Excellent knowledge of the clinical trial process.
The final candidate will be offered an attractive remuneration package inclusive of fringe benefits.
Email : firstname.lastname@example.org
Telephone : +31 (0) 653 17 89 48
FaceTime-Whatsapp: +31 (0) 653 17 89 48
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