Business minded top-level manager with broad experience in MedTech/Biotech/Pharma product development? Have a look at th

Senior Vice President Product Development

To strengthen the company’s top management team and head the product development division, SoftOx Solutions is hiring Senior Vice President (SVP) of Product Development.

Being in charge of SoftOx Solutions’ product development from early-stage scientific development until commercial manufacturing, the SVP heads and coordinates a cross-functional team in innovation, chemical and biological R&D, regulatory work, manufacturing, pre-clinical and clinical development recommend to the Board and CEO. The SVP gives strategic directions of all product development activities, focusing on optimizing existing technology and also the next generation of new innovative products.

The SVP has a strong scientific background documenting successful product development experience within the MedTech/Biotech/Pharma industry. SVP is part of the SoftOx Solutions top management team and reports directly to CEO.
 

Primary Responsibilities

The SVP manages a highly competent management team consisting of VP Global Medical Affairs, Director of CMC, Director of Scientific Research and Director of Regulatory Affairs.

Combining scientific, regulatory, and in-depth business knowledge, the SVP ensures that SoftOx Solutions products meet required legislation for successful product registrations in markets in question.

This includes overseeing that SoftOx Solutions innovates, develops and successfully secures optimal execution of project plans for timely product registrations, and coordinating different product development projects, and overseeing that activities at contract research organizations comply with internal and external requirements for both pharmacovigilance and medical device vigilance.

Other tasks included in the position:
 

• Ensure timely approval and maintenance of medical device, biocide, and pharmaceutical products in compliance with general guidelines and local laws
• Manage the company’s business development for optimizing product development strategy in regard to reimbursement, regulatory requirements and payers and user’s needs
• Secure the company’s need for minimizing time to market and secure project plan execution according to budgets and schedules
• Ensure compliance of organizational structures, internal processes, operational activities, and reporting
• Oversee collaborations with contract research organizations and the scientific quality to maintain and enhance reputation for excellence
• Contracting (external vendors)
• Secure allocation of resources to fulfil development strategy
• Ensure organisation compliance in accordance with applicable regulations and company policies
• Interpret regulatory requirements and oversee aspects of license submission, authorizations of products, international registrations and dossiers, including assessing product changes and any impact this may have on the status of regulatory licenses
• Respond on regulatory agency inquiries and other correspondence

 

Qualifications

PhD, MD or MSc within the fields of pharmacy, chemistry, medicine, or other life sciences disciplines.

Solid experience (at least 10 years) and track record from top-level management in Innovation & Product Development within the MedTech/Biotech/Pharma industry is required.

Expert knowledge combined with strong business acumen. Good understanding of medical device and/or pharmaceutical manufacturing processes, quality requirements and related judgements.

Well-organized and self-directed with strong interpersonal skills and ability to communicate with people at all organizational levels.

Inspiring team leader ensuring creative and positive working conditions.

Excellent English verbal and written communication skills.
 

Conditions

The position is based at the company headquarter in Oslo. Periods with extensive travelling must be expected.

The right candidate will be offered competitive salary and benefits and join an exciting working environment with professionally strong and enthusiastic team members.


For more information, please contact Kristian Knudsen, tel. no. +47 928 00 000 or Geir Olderbakk, tel. no. +47 900 28 283 at Orion & Partners.

Would you rather we called you? Text #769 to +47 900 28 283.