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

Arcetyp LLC; Gaithersburg (MD); Remote; USD 120,000 - 180,000; Full time

Job summary

Arcetyp LLC in Fort Detrick, MD, is seeking a Senior DoD Medical Product Program Manager - Clinical & Regulatory to oversee regulatory and clinical program activities for therapeutics and related products.

The role involves coordinating FDA/IRB activities, leading IPTs, and ensuring compliance with cGMP/cGCP, DoD medical acquisition processes. On-site position with federal-facing responsibilities.

Ideal candidates have strong regulatory writing, IND support, and stakeholder management.

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%.

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.

Skills

FDA-regulated product development

Investigational products

Clinical protocol management

Regulatory affairs and documentation

DoD medical acquisition environment

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.