Job Description
Join our dynamic Clinical group of CAS located in the vibrant city of Mounds View, MN. This is an exciting opportunity to be part of a team that supports clinical-regulatory filings for pre-market and post-market technologies across all geographies, contributing to global medical affairs operations with real-time scientific assessments and dissemination.
Responsibilities
- Lead the authoring and critical review of scientific and Clinical Evaluation documents.
- Analyze complex clinical data into clear, accurate, and defensible written summaries.
- Ensure documents are scientifically sound and consistent.
- Function as a recognized independent Subject Matter Expert (SME) influencing decisions.
- Provide strategic clinical input to internal teams and leadership.
- Represent Clinical in cross-functional planning and help the organization understand the clinical implications of decisions.
- Oversee, design, plan, and develop clinical evaluation research studies.
- Prepare and author protocols and patient record forms.
- Conduct registered and nonregistered clinical studies of products that satisfy medical needs and/or offer commercial potential.
- Oversee and interpret results of clinical investigations for new drug, device, or consumer applications.
- Resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations.
- Prepare clinical trial budgets and manage clinical supply operations, site, and vendor selection.
- Exceptional medical writing experience.
- Deep clinical research and clinical evidence development experience.
- Expert-level ability to write, edit, and finalize documents.
- Ability to connect scientific evidence to regulatory, commercial, and clinical needs.
- Exceptional medical writing and scientific communication skills.
- Foundational cardiac knowledge and experience with electrophysiology procedures/technology.
Normal day shift. The interview process includes 2-3 rounds, with a mix of video and phone interviews as needed.
Required Knowledge and Experience
Requires mastery level knowledge of specialty area and working knowledge of several other areas, typically obtained through advanced education combined with experience. A University Degree and a minimum of 10 years of relevant experience, or an advanced degree with a minimum of 8 years of relevant experience are required.
Numbers & Facts
| Location | Mounds View, MN |
| Industry | Staffing/Employment Agencies |
| Salary | $60 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Budgetingunmatched
- Clinical Assessmentunmatched
- Clinical Dataunmatched
- Clinical Outcomesunmatched
- Clinical Practices/Protocolsunmatched
- Clinical Researchunmatched
- Clinical Study Publicationsunmatched
- Clinical Supportunmatched
- Clinical Trialunmatched
- Clinical Trial Managementunmatched
- Communication Skillsunmatched
- Cross-Functionalunmatched
- Data Analysisunmatched
- Drug Developmentunmatched
- GCP (Good Clinical Practices)unmatched
- Leadershipunmatched
- Medical Affairsunmatched
- Medical Productsunmatched
- Medical Recordsunmatched
- Medical Writingunmatched
- Medical and Scientific Writingunmatched
- Operations Managementunmatched
- Regulationsunmatched
- Regulatory Submissionsunmatched
- Scientific Publicationsunmatched
- Standard Operating Procedures (SOP)unmatched
- Vendor/Supplier Selectionunmatched
- Writing Skillsunmatched
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