Senior Product Management Support I (Force Health Protection)

Knowesis Inc.; Frederick (MD); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health Insurance

401k Company Match

Voluntary Products

Job summary

Knowesis Inc. is seeking a Senior Product Management Support I for Force Health Protection to oversee product management and clinical protocol accountability. This role manages IND products, ensures adherence to cGCP, cGLP, and cGMP, and coordinates with the FDA to support clinical development of therapeutics and diagnostics.

The position is based at Fort Detrick, MD with hybrid/telework options. It requires the ability to obtain and maintain a relevant clearance and to work with DoD and FDA

Qualifications

• Bachelor's Degree in a scientific, health, or related field.
• At least 8 years of full-time work experience in clinical/FDA regulatory product development.
• Demonstrated knowledge of cGCP, cGLP, and cGMP.

Responsibilities

• Develop regulatory documentation and provide annual/refresher GCP training to staff.
• Coordinate management of clinical protocols, therapeutics, prophylactics, and diagnostics with FDA/DoD compliance.
• Collaborate with the DHA Office of Regulated Activities to ensure IND protocols meet regulatory requirements and support submissions to FDA/IRBs.
• Provide storage, protocol management, and oversee product release for FHP IND products.
• Review technical documents and provide recommendations to ensure sound scientific processes for investigational products.

Skills

Regulatory documentation

IND protocol management

FDA/IRB coordination

cGCP/cGLP/cGMP knowledge

Education

Bachelor's Degree in a scientific, health, or related field

Advanced degree in a scientific or health-related discipline (preferred)

Job description

Brief Description

Position: Senior Product Management Support I (Force Health Protection)

Location: Fort Detrick, MD

Work Environment: Hybrid / Telework Eligible (Routine and situational telework is authorized.)

Clearance Required: TIER 1: Non-critical sensitive position (Must be able to obtain and maintain)

Status: Contingent

Anticipated Salary Range: $120,000 - $160,000

Knowesis is seeking a Senior Product Management Support I for Force Health Protection (FHP) to oversee product management and clinical protocol accountability. This role manages Investigational New Drug (IND) products, ensures adherence to Good Clinical Practices (GCP), and coordinates with the FDA to support the clinical development of therapeutics and diagnostics.

The Job Duties and Responsibilities include but are not limited to the following:

• Develop regulatory documentation, organize, and provide annual and refresher Good Clinical Practices (GCP) training to medical and laboratory staff.
• Coordinate the management of clinical protocols, therapeutics, prophylactics, and diagnostics, ensuring compliance with FDA and DoD regulations.
• Work with the DHA Office of Regulated Activities to ensure IND protocols meet all regulatory requirements and support submissions to the FDA and Institutional Review Boards (IRB).
• Provide storage, protocol management, and oversee product release for FHP IND products.
• Review and analyze technical documents, making recommendations to ensure sound scientific processes are used in support of investigational products.

Required Qualifications

• Bachelor's Degree in a scientific, health, or related field.
• At least 8 years of full-time work experience in clinical/FDA regulatory product development.
• Demonstrated experience and knowledge of Current Good Clinical Practice (cGCP), Current Good Laboratory Practices (cGLP), and Current Good Manufacturing Practices (cGMP).

Preferred Qualifications

• Advanced degree in a scientific or health-related discipline.
• Extensive experience managing IND protocols and interacting with the FDA and IRBs.

Benefits

• Health (PPO & HDHP) Insurance, Dental, Vision, STD & LTD, Basic Life Insurance, 401k Company Match, & Voluntary Products.

Knowesis is committed to providing equal employment opportunities to all individuals based on merit and qualifications. We prohibit discrimination in all aspects of employment as required by Title VII of the Civil Rights Act and other applicable federal laws. Our company values all applicants and employees and fosters a work environment where everyone is treated with respect and dignity.