Medical Affairs Customer Specialist

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

RESPONSIBILITIES:

The customer engagement
- Core Team member- MA (CE-CTM-MA) responsibilities for managing studies for the allocated products under development includes the following:

Be part of the team representing the organization as one of the prime Medical Affairs contacts to a pharma partner on a Business-to-Business product development project.

Deliver on new and exciting advanced drug delivery solutions as a technical leader on a cross-functional project team through all phases of the project lifecycle, from concept through launch.

Translate business requirements into a robust, scalable technical design linked to device usability.

Work closely with both functional teams and project managers to identify and mitigate issues to reduce programmatic risks.

Support customer requests on current data available for the platform (clinical or Human Factors)
Collaborate cross functionally to support customers on non Medical Affairs topics (risk management, design requirements)
Participate with the Platform Core team member and extended team members in the execution of the strategy for the product development

Contribution to publication writing

The Customer engagement
-Core Team Member-MA interacts with product core teams and members:

Represents Medical Affairs in several customer core team and cluster handling new product development

Is accountable to the core team leader for deliverables of the Medical Affairs function

Ensures deliverables produced by Medical Affairs function meet the appropriate quality standards

Communicates progress and facilitates decision making with the core team and Medical Affairs function

Prepares and delivers presentations covering relevant Medical Affairs information (functional capabilities and clinical and HF study data) to customers during TC and face to face customer meetings Additional Responsibilities:

Representing MA within a team of QA, Research and Development, Regulatory Affairs, Marketing, and Manufacturing team members by facilitating effective communication and engagement.

Demonstrate excellent interpersonal communication skills, which enable you to gain client trust and mentor junior  an agile learner, tolerant of risk, and biased towards action

Effectively and clearly communicate concepts, ideas and knowledge to other individuals, teams and customers

Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety laws, policies and procedures.

The CE-CTM-MA participates in establishment and updating of the SOPs related to the C&HF development activities. The CE-CTM-MA is also expected to attend and complete assigned training courses concerning medical devices and human factors. It is expected that the CE-CTM-MA acts as a leader of the Medical Affairs department, and mentors other individuals formally or informally. The CE-CTM-MA is expected to set an example with respect to work ethic, maturity, and adherence to Regulations and Guidelines, industry best practices, and BD guiding principles.

The CE-CTM-MA is expected to contribute as required to cross department and corporate initiatives, and to share their expertise. The CE-CTM-MA may be expected to travel intermittently as required to achieve his/her routine responsibilities. He/she must be available for limited domestic or international travel as-needed basis. Travel should not exceed 25 percent of his/her time.

POSITION REQUIREMENTS Education Scientific background, (Biomedical Engineering, Masters or PhD in Biological Sciences, or Pharm

D preferred)
Experience 3 years of preferably studies experience, within the Pharmaceutical or the Medical device industry, with good understanding and knowledge of Medical device environment (including design control); regarding applicable Quality / Regulation, a good…