Specialist Prin, Product Risk - 101545 - Marlborough, MA - 0300 Posted Date: August 22, 2013

Job Description

Clinical Risk Manager

Purpose Statement:

Responsible for the analysis and communication of clinical product risk across the project and product lifecycle. Provides guidance in safety signal detection and assessment to communicate safety risks to project teams and senior management. Ensures compliance with regulatory standards and guidelines, and corporate standard operating procedures as they relate to safety risk management.
Key Responsibilities:

·          Identify appropriate scope and comparative information for CES/CRBA and drive generation or updates for those documents. Collaborate with cross-functional partners to obtain additional input (i.e. Quality for Field Experience data) to aid in clinical risk analysis
·          Conduct literature search on products/product families to interpret and summarize harms, hazards, alternate therapies and device specific benefits from literature; collect and summarize primary data from the Design History File to support risk assessment.
·          Identifies the need for and/or generates risk management related documents on BSC products (commercial or under development) to support internal BSC and external regulatory agency requirements
·          Serves as a liason between Risk Management function and project team. Clearly communicates pertinent project/function information.
·          Collaborate with Clinical and R&D to develop common Clinical deliverable criteria and strategize justification for no clinical trial or aid in development of clinical trial rationalization plan. Collaborate with Medical Sciences by providing harms, hazard and benefits information for the development/updates of the DFU, RAWB and FMEA documents.
·          Mentors and serves as subject matter expert in key risk management activities; participates as a risk management consultant for complex projects and for grouping similar products into logical and sustainable structure.
·          Dependent on level, may serve as SME and Function representative in internal and external audits including audit participation, back room SME, preparing audit responses and supporting process improvements resulting from the audit.

Quality System Requirements:

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Experience Required

Qualifications:· Bachelor?s degree in Science/Engineering required, preference to RN/DVM/MD; Master?s or above preferred. Related experience: 6+ Years with BS/BA, 4+ years with MS/MA· Strong analytical skills. Ability to synthesize and summarize medical/technical literature, and shape conclusions that drive decisions. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors· Solid medical scientific writing skills· Attention to detail and strong organizational skills· Able to understand and communicate regulatory issues/concerns, with the capability to distill strategic improvements or advantages that can be adopted within the requirements for BSC processes· Solid understanding and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations· Audit experience (regulatory agency or notified body preferred)The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.