Manager, Scientific & Technical Affairs

Job Description

Job DescriptionDescription:

The Urgo Medical North America (UMNA) Manager of Scientific & Technical Affairs is responsible for providing scientific and technical support across product development, regulatory submissions, and commercial activities. This role bridges the gap between R&D, regulatory, and marketing by ensuring scientific accuracy and compliance with industry standards and regulations. Common daily tasks in this position include execution of specific projects identified by the VP of Medical Affairs & Innovation, and will generally consist of understanding the history, chemistry, and evidence base of the products and brands within the UMNA portfolio, and the leading brands/technologies in the competitive landscape.

In addition, the Manager of Scientific & Technical Affairs will be responsible for ensuring the timely achievement of all objectives through effective coordination with both external stakeholders, such as Key Opinion Leaders and internal teams at local and global levels. All activities must be executed in a compliant manner, aligned with AdvaMed guidelines and Urgo’s compliance policies, and within assigned budget parameters. The candidate must also stay current with published scientific literature and attend relevant meetings to remain informed about company and team progress and developments. Additionally, be proficient in effectively communicating and presenting project-related information to both internal and external stakeholders.

Requirements:

Duties and Responsibilities

• Work in close collaboration with the VP of Medical Affairs & Innovation to align priorities and support the accomplishment of the department goals and objectives.
• Drive and create abstract submissions, and write independently clinical/preclinical abstracts, posters, whitepapers, journal manuscripts on specific projects identified by the VP of Medical Affairs & Innovation.
• Understand the review process of promotional materials and activities, ensuring compliance with the relevant Code of Practice and execute requested reviews.
• Safely and accurately address unsolicited off-label product inquiries under the guidance of the VP of Medical Affairs & Innovation. Lead and/or participate in the design and execution of pre-clinical and/or basic science research related to a concept or product investigation, product development, or regulatory registration..
• Maintain and nurture relationships with thought key opinion leaders and external experts, working toward common scientific objectives with them.
• Maintain up-to-date knowledge of regulatory developments, and compliance processes.
• Serve as an additional key support resource to the VP of Medical Affairs & Innovation, providing guidance to UMNA employees, customers, and partners. Work closely with the Commercial Excellence, RA/QA, Legal, HCS, and Canadian teams with a key objective to help Clinicians Help Patients.
• Work closely with Urgo Global R & D department as requested by the VP of Medical Affairs & Innovation.
• Present educational information about a product or technology landscape at meetings.

Competencies

• Excellent verbal and written communication skills, including expertise in scientific writing, with the ability to convey complex information clearly and effectively to a wide range of audiences. Attention to detail and strong analytical and problem-solving skills.
• Exhibits a strong sense of energy and enthusiasm, consistently approaching challenges with passion and a proactive attitude.
• Demonstrates a strong personal and professional history of leadership, as well as developing and maintaining strong, effective relationships with both internal & external stakeholders.

Requirements

• Master’s degree in scientific discipline (e.g., Chemistry, Biology, Biochemistry, Microbiology, Pharmacy); or PhD preferred
• 5+ years of pharmaceutical/medical device experience preferred.
• Possesses in-depth knowledge of infection control issues and advanced wound care management
• A high level of knowledge of the regulatory landscape of major regulatory agencies in the wound care/infection control space, and their approval processes.
• A proven track record of professional publications demonstrably written by the candidate.
• A proven track record of public speaking and presenting complex information.
• Must have experience working in cross-functional teams and managing multiple projects simultaneously.

Work Environment

• Indoors, in an office environment, with temperature control.
• No adverse environmental conditions expected.
• Travel: up to 40%, with the potential for overnight and international travel.

Physical Demands

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers. The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; the ability to operate standard office equipment and keyboards.

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.