Sr. Scientist/Principal Scientist - GRA CMCD, Drug Delivery Device

Sr. Scientist/Principal Scientist - GRA CMCD, Drug Delivery Device

Eli Lilly Benelux

Cork, Ireland

Purpose

The purpose of the Sr. Scientist/Principal Scientist role is to provide tactical, and operational direction and support to expediate device related (drug-device delivery systems, medical devices (firmware, hardware, stand alone and embedded software) registrations, right to operate and maintenance of Lilly’s portfolio by interacting with teams, affiliates, and regulators. This role will support global registrations, product maintenance, and GRA-Devices: GRA-CMCD Drug Delivery Device department operations.

The Scientist utilizes device technical knowledge, regulatory and device expertise to drive internal consistency and influence effective change management.

Primary Responsibilities

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Regulatory and Scientific Expertise:

• Technical knowledge of drug delivery and/or medical device, including software, systems development science(s) development and lifecycle management.
• Support evaluation of regulatory impact on proposed delivery systems and/or medical device change management plans.
• Anticipate and resolve key technical or operational issues that can impact the function or product team.
• Support regulatory risk – benefit analysis, internal and external audits for regulatory compliance.
• Demonstrate strong skills in technical and concise writing of Regulatory documents resulting in effective communication and maximizing feedback from regulators.

Influence:

• Provide regulatory guidance to product teams and/or affiliates while implementing regulatory strategies that result in successful global product registrations and device maintenance.
• Exhibit leadership behaviors.
• Incorporate new regulations, guidance and company positions into GRA-Device processes/guidelines, tools and/or training materials.
• Support internal policy development and provide internal input on emerging regulations worldwide for device issues.
• Monitor global regulatory news and provide interpretation and internal communication as appropriate.
• Support interactions with global Heath Authorities as required, including key ISO and notified body personnel.

Lead/Support/Partner:

• Support preparation, review, and finalization of device documents for global clinical trial authorizations (CTA), registration submissions, response to questions and change control activities.
• Support strategies impacting product submissions across geographies.
• Proactively identify and resolve device regulatory issues, leveraging internal experts and/or GRA-Devices subject matter expert (SME) and/or mentor.
• Communicate effectively verbally and in writing to influence within work group/function and with product team.
• Support the development of corporate positions on, and responses to, proposed agency regulations and guidelines.
• Participate in forums that share regulatory information across GRA components.
• Collect and collate GRA-Devices metrics.
• Support regulatory impact assessments.
• Serve as electronic data systems SME.
• Support regulatory intelligence activities.
• Identify and execute other operational responsibilities.

Decision Making:

• Proactively identify and resolves device regulatory issues.

Minimum Qualification Requirements

• Bachelor’s degree in a scientific or engineering discipline (e.g. chemistry, biology, biochemistry, pharmacy, engineering or related scientific discipline).

Other Requirements:

• Medical Device or Pharmaceutical industry experience in technical drug and/or device development (3-4 years)
• Prior experience authoring device submission content
• Prior regulatory experience (2-3 years) or equivalent combination of technical and regulatory guidance knowledge
• Demonstrated negotiation and influence skills.
• Demonstrated strong written, spoken and presentation communication skills
• Demonstrated attention to detail
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

Other Information/Additional Preferences:

• English Fluency.