Scientific and Clinical Affairs Associate
Location
Hapeville, GA | United States
Job description
The Scientific and Clinical Affairs Associate will have strong organizational skills, attention to detail, the ability to thrive under tight deadlines, and the ability to communicate across all levels of the organization. This is an exciting opportunity for a motivated self-starter to join a fast growing, highly collaborative and fun team. This is a remote position that can be anywhere in the United States
Specifically, The Scientific Affairs role is focused on the overall, Medical and Scientific Affairs' teams goals of Outreach, Training, Research, and Support; as well as the Clinical Affairs' teams goals of managing and MagnetOs post-marketing clinical trials.
Primary Job Duties:
* The Clinical Associate role consists of compiling regulatory submissions, managing study tracking tools and eTMF; completing documentation in a timely manner, and creation and distribution of Kuros Biosciences scientific information.
* Create and obtain compliance for medical presentations given by the Medical Affairs team and/or affiliated surgeons speaking on behalf of Kuros.
* Submit abstracts for presentations globally.
* Work collaboratively on scientific writing; specifically white papers, publications, and clinical manuscripts.
* Interact with the sales and marketing teams to strategically collaborate on projects and manage events.
* Support the various teams such as sales, marketing, development, quality and regulatory, and others as needed for specific projects.
* Clinical trial data management and support of sites.
* Engage with Key Opinion Leaders (KOLs) in the fields of medicine or research.
* Respond to scientific enquiries from internal and external colleagues.
* Prioritize and strategize on requests for the Scientific Affairs Team.
* Manage invoicing and purchase orders for Scientific Affairs events, in collaboration with the Scientific Affairs Team.
* Stay informed on the latest scientific research and clinical data relevant to Kuros Biosciences.
* Review eCRFs and reports, ensuring that clinical trials are being conducted in accordance with protocols, GCP, ICH, SOP's and regulations (FDA/DEA).
* Ensure the set up and maintenance of project plans are in compliance with company policies and timelines.
* Identify, address and/or escalate study related risks, issues, mitigations, and opportunities for improvements.
* Review and track clinical invoices
* Expected travel of 3-5 days/month.
Experience and Qualifications
* Master's degree in a life sciences field, e.g. Biology, Chemistry, etc...
* Minimum 3 years medical device industry experience. Experience in leading clinical projects is advantageous.
* The highest ethical standards, specifically surrounding protected medical information and clinical research.
* Working knowledge of relevant clinical regulations and industry standards including Good Clinical Research Practice and MedTech EU Code of Practice.
* Working knowledge of the Guidelines of the Medical Science Liaison Society and the Project Manager Professional (PMP) Clinical Certification
Additional Requirements:
* Organized, detail oriented, exceptional ability to manage timelines and deadlines.
* Excellent communication and presentation creation skills.
* Teamwork skills and an ability to work effectively in a cross-functional setting with a variety of colleagues.
* Networking skills and the confidence to interact with senior experts and orthopedic and neurological surgeons.
* Critical data analysis skills.
* An ability to keep up to date with scientific literature.
* Skillful at scientific and clinical writing.
* A high level of emotional intelligence to work effectively with stakeholders.
* Commercial acumen.
* The ability to understand, process, communicate, and present scientific information to a high standard.
* External customer focus with strong networking capabilities and integration with KOLs.
* Ability to manage multiple projects simultaneously and adapt priorities according to business and strategic needs.
* Ability to work independently without immediate supervision (if remote)
* Other duties as assigned
Compensation and incentive highlights
* Competitive base salary ($50k -$60K)
* Comprehensive medical, dental, and vision coverage
* Generous PTO
* 401(k) with a company match
* Paid Parental Leave
* Flexible spending account
ABOUT US
Kuros is a Swiss-headquartered biotech company, listed on the SIX Swiss Stock Exchange (Ticker: KURN) since 2016. With operations in the Netherlands and the USA, we employ a growing team of 75 people.
To deliver the ideal bone graft, you need the highest quality and quantity of scientific evidence behind it. We believe that this is a key differentiator for Kuros, given the urgent need to reduce spinal fusion failure rates. Our credentials:
* A commercial & research footprint that spans 3 continents and covers 19 markets.
* >25 biologics-related patents
* 10 well-controlled Level I-III clinical trials initiated, including 3 that are complete
* >15,000 patients treated worldwide with our bone graft technologies
* 4 teams of internationally renowned clinical and scientific expert advisors, including 18 Key Opinion Leader (KOL) spine surgeons.
OUR FOCUS
Today, nearly 1 in 5 spinal fusions fail. But what can we do to change this situation - for the benefit of patients, surgeons, and our wider society?
This is the question that drives us at Kuros. Every day our team works across three continents to unlock the hidden secrets of bone healing through our research, development, and technology program: Project Fusion.
To deliver the ideal bone graft, we believe you need the highest quality and quantity of scientific evidence behind it. Which is why Project Fusion brings together an unprecedented blend of scientific, pre-clinical and clinical studies - all aimed at making the unpredictable...predictable.
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