Process Advisor IV GS14

US-VA-Dahlgren
# of Openings
3
Category
Proposals
Type
Contract

Overview

CAMRIS International is an international development and research firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. With experience working in more than 80 countries, we combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. We apply a customized, customer-centric, cost-effective business approach to offer greater value to our clients and challenge the way things have always been done in our field.

 

CAMRIS clients include U.S. government agencies and multilateral and private organizations. Our core practice areas include public health, agriculture and food security, economic development, education, environment, humanitarian assistance, democracy and governance, and medical research. 

 

The Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) has ongoing requirements for program management, systems engineering, and technical advisory and assistance contract services to support the research, development, production, procurement, fielding, sustainment, and continuous product improvement of Chemical, Biological, Radiological, Nuclear and High-Yield Explosive (CBRNE) Defense systems.

 

The JPEO-CBD manages a dynamic and diverse portfolio of critical warfighting capabilities, requiring an approach for cohesive and innovative total life cycle systems management to rapidly respond to customer needs in a cost-effective manner. The JPEO-CBD is the Joint Services advanced developer for research, development, acquisition, production, procurement, fielding, and life-cycle sustainment support of Chemical and Biological Defense (CBD) equipment and medical countermeasures systems. The JPEO-CBD supports all military services, as well as homeland defense, allies, and United States (US) citizens and troops located within and outside of the Continental US (CONUS and OCONUS).

 

Under the Joint Enterprise-Omnibus Program, Engineering, and Technical Support-Logistical and Medical (JE-OEPTS-LM) requirement, CAMRIS may be required to fulfill the medical portion of this requirement which includes all support associated with the product concept and design, and policy and protocol development of all JPEO-CBD systems relating to biologics, vaccines and pharmaceuticals.

 

To facilitate this support requirement, the JPEO-CBD has identified the following areas of interest to categorize Medical Drug Development Policies & Procedures.

 

This is an opportunity for employment or a contract, but we reserve the right to make no selection or award. Contingent on bid award.

Responsibilities

The offeror shall provide scientific and technical support during the development or transfer of new biologics and other medical technologies.

The offeror shall assist in determining strategic direction of the project office by proposing and implementing actionable strategies to address critical issues.

The offeror shall review pertinent correspondence and related documents for scientific and medical content, and evaluate all aspects of the clinical study protocol. Additionally, the offeror shall provide insight on current good laboratory and manufacturing processes and FDA requirements.

The offeror shall advise the client on the impact of changing trends in the pharmaceutical industry and FDA policies and requirements, and recommend courses of action.

The offeror shall provide advice on the impact of legislative changes and directives from higher echelons and recommend courses of action, as well as ensure application of pertinent inter-state and foreign commerce laws and regulations governing manufacturing and shipment.

In addition, the offeror shall facilitate communication and coordination with the FDA, as required.

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