Senior DoD Medical Product Program Manager – Clinical & Regulatory - Telework

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. We accept direct hire candidates only, W2 employee hires. We do not accept 1099 independent consultants. We do not accept staffing firms. We do not accept corp-to-corp (C2C) candidates.

Arcetyp LLC is looking for a Senior Dod Medical Product Program Manager - Clinical & Regulatory . This position is onsite and located in Fort Detrick, MD.

About arcetyp

We can't sponsor H1B.

Responsibilities

• Support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols.
• Develop/review regulatory documentation.
• Coordinate FDA/IRB activities.
• Participate in and lead IPTs/working groups.
• Support IND product accountability, protocol management, technical reports, training, and stakeholder coordination.
• Investigational product/program management.
• FDA/IRB regulatory coordination.
• Clinical protocol management.
• GCP training and regulatory documentation.
• Stakeholder/IPT leadership.
• Product accountability and technical analysis.
• FDA-regulated medical product development.
• Regulatory affairs and technical documentation.
• DoD medical acquisition environment.
• FDA submission and IRB coordination experience.
• Prior military medical countermeasure program support.
• Min.

Requirements

• Knowledge of cGCP, cGLP, cGMP and Title 21 CFR.
• Ability to support IND regulatory requirements.
• Strong technical writing and stakeholder coordination.
• Up to 20% PREFERRED QUALIFICATIONS: Current FHP incumbent.

Preferred

• Investigational products.
• Clinical protocol/project management.

Pay

• Fort Detrick, MD COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply.
• Arcetyp offers a package of compensation and benefits to full-time salaried employees.

Benefits

• we value and reward our team's dedication and hard work.
• We provide a competitive base salary commensurate with your qualifications and experience.
• As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.

Travel

Direct experience with the existing FHP portfolio. DHA/DoD IND management.

Citizenship Status Required

U.S Citizenship.

Pay and Benefits from our client

Arcetyp is an Equal Opportunity Employer and we highly value diversity of our workforce. We accept resumes from all interested parties and consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, sexual preference, personal appearance, family responsibility, the presence of a non-job-related medical condition or physical disability, matriculation, political affiliation, veteran status, or any other legally protected status.