Senior DoD Medical Product Program Manager – Clinical & Regulatory

Arcetyp LLC; Bethesda (MD); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) match

Paid time off

Professional development

Job summary

Arcetyp LLC seeks a Senior DoD Medical Product Program Manager - Clinical & Regulatory to lead regulatory documentation, clinical protocol management, and regulatory coordination for DoD healthcare programs.

The role is onsite at Fort Detrick, MD, requiring strong cGxP knowledge, IND experience, and stakeholder coordination to ensure compliant product development and program execution.

Qualifications

• Knowledge of FDA-regulated medical product development and 21 CFR requirements.
• Ability to support IND regulatory requirements and regulatory documentation.
• Strong technical writing and cross-functional stakeholder coordination.

Responsibilities

• Support product/project management of therapeutics, prophylactics, diagnostics, and clinical protocols.
• Develop and review regulatory documentation for FDA/IRB activities.
• Coordinate FDA/IRB activities and participate in IPTs/working groups.
• Support IND product accountability, protocol management, technical reports, and stakeholder coordination.

Skills

cGCP/cGLP/cGMP

IND regulatory support

Technical writing

Stakeholder coordination

Job description

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. We can't sponsor H1B.

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

ESSENTIAL JOB FUNCTIONS:

• 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.

NECESSARY SKILLS AND KNOWLEDGE:

• FDA-regulated medical product development.
• Investigational products.
• Clinical protocol/project management.
• Regulatory affairs and technical documentation.
• DoD medical acquisition environment.

MINIMUM QUALIFICATIONS:

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

PREFERRED QUALIFICATIONS:

• Current FHP incumbent.
• Direct experience with the existing FHP portfolio.
• DHA/DoD IND management.
• FDA submission and IRB coordination experience.
• Prior military medical countermeasure program support.

Min. Citizenship Status Required:
U.S Citizenship.

LOCATION:
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. Pay and Benefits from our client: we value and reward our team's dedication and hard work. 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.

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.