Remote Director, Medical Affairs (Orthopedics)
Kforce Inc.
Carlsbad, California
RESPONSIBILITIES:
Kforce has a client is seeking to hire a Remote Director, Medical Affairs (Orthopedics) in Carlsbad, California (CA).Responsibilities include:- Collaborate on training manuals and product monographs
- Review promotional materials
- Provide input into labeling changes to RA
- Remote Director will collaborate with the CMO and CS leader on the Medical Advisory Board on-boarding, contracting, payment, schedule, etc.
- Collaborate with the CMO, CA, CS and other cross-functional team members in the review and interpretation of data
- Collaborate on the development of the clinical study protocol, protocol amendments, and periodic update of CEPs and CERs
- Provide review and input to clinical and scientific aspects of regulatory filings, including technical summaries, labeling statements, IFU, Claims, Annual Progress Reports, CEPs and CERs
- Develop an effective working relationship with multiple internal stakeholders including CA, CS, RA, QA, R&D, and Marketing/Communication
- Remote Director will develop a strong working relationship with customer HCPs and KOLs
- Collaborate and partner with Legal and Compliance and perform all responsibilities in full compliance with regulatory requirements, legal requirements, and industry guidelines
REQUIREMENTS:
- Bachelor's degree with orthopedic surgery experience; Master's degree preferred
- 5-10+ years of industry experience in a Medical Affairs position of a Class III device
- Ability to travel up to 20%
The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.
We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.
Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.
This job is not eligible for bonuses, incentives or commissions.
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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