(Archived) Business Development and Continuity Expert

Description

The Business Development expert will have solid knowledge in the readiness of global and local audits/inspections within the Global Clinical Trial Unit (GCTSU), (Germany, US and Japan) to include Good Clinical Practice and Good Medical Practice regulations and host such inspections with timely response per auditor’s request. Including agency authorities, self-inspections and global vendor audits as required in collaboration with the Business Development team member GCTSU Biberach/Germany, Japan. Additionally, supports the compliance team within the GCTSU Business Development Continuity team.
The position requires solid experience working in a fast pace global development environment as a subject matter expert, willingness to work independently with delivery of efficiencies regarding focus to high quality standards in support of our patients.

Duties & Responsibilities

• Responsible for the training system for all CTSU staff and team leaders, provide guidance regarding the details of compliance importance working in a GMP environment.

• Collaborates across all GCTSU functions with global stakeholders both internal and external to ensure that GCTSU audits and inspections are conducted according to pharmaceutical regulations.

• Interfaces internally/globally with Clinical Operations in support of GCP audits/inspections and auditor requests.

• Drives the culture of Innovation and Continuous Process Improvements (CPI), with demonstration of Project Management Leadership values.

• Responsible for the support of audit/inspections and compliance tasks in collaboration with BD Biberach colleagues, to be achieved with the expectation of minimal supervision and direction.

• Potential projects including a solid focus on ability to identify needed improvement(s) on existing processes and implementation of revisions in support of patients within global clinical trials.

• Supports/contributes to CPI projects in collaboration with Project Lead.

• Interfaces internally/globally with Clinical Operations in support of GCP audits/inspections and auditor requests.

Requirements

• Master's degree and 3+ years' experience or Bachelor's Degree and 6+ years' experience in a related scientific discipline.
• Must have solid knowledge specifically in the areas of GCP, GMP and Global Regulatory requirements in relation to Global Clinical Trials (Ph-1 – Ph-IV) audits and inspections as related to the Pharmaceutical Industry.
• Demonstration of up-to-date knowledge and understanding of applicable Global Regulatory requirements within the Pharmaceutical Industry preferred.
• Project management skills desirable
• Proven ability to drive results in a fast-paced environment.
• Demonstrates effective verbal/written communication skills in support of presentations.
• Fluent in English language and writing for both daily and technical language.
• Willingness to travel within the USA and occasionally within Europe.
• Demonstrates a high standard of GMP and GCP knowledge; all work undertaken must be compliant to the regulations of MHRA, EMEA and FDA authorities.
• Exhibits the ability to expound complex project requirements and can interpret highly complex experimental data and relate this to project requirements.
• Proven ability to present complex projects / status reports, break down the important factors to a varied audience of global external/internal stake holders.
• Ability to work independently in local/global teams, and drive finalization of decisions.
• Must have a motivational character towards project team members and accountability for timely delivery of the clinical supply process for IMP, AxMP, commercial comparators and clinical devices.
• Business knowledge, skills, and experience in project management leadership
• Product knowledge of major IMP, (Investigational Medicinal Products) and the relevant distribution parameters and market knowledge of the major activities undertaken by our business competitors.
• Willingness to learn new technologies and concepts working within global supply chain activities as it relates to global clinical trials Ph I- Ph IV

Compensation Data

This position offers a base salary typically between $102,000 and $175,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.  For an overview of our benefits please click here.