Research Scientist- Device Global Regulatory Affairs
Company OverviewAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. #WeAreLilly
ResponsibilitiesAs a Research Scientist in our Device Global Regulatory Affairs organization, you will have the opportunity to provide strategic, tactical and operational direction and support to expedite device (delivery system and / or digital health) development of Lilly’s portfolio by interacting with teams and regulators to develop successful regulatory strategies and submissions in support of clinical trials and market clearance/registrations. We are seeking a skilled scientist to utilizes their device technical knowledge and regulatory expertise to drive internal consistency and influence effective change management.
Regulatory & Scientific Expertise
- Technical knowledge of drug delivery and / or digital health systems development science(s)
- Recognized within GRA for broad knowledge of global delivery system and / or digital health regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations
- Manage the development of regulatory strategy and update strategy based upon global regulatory changes
- Provide high quality, timely and decisive regulatory advice to allow product teams to make well-informed decisions on development or product lifecycle planning
- Evaluates regulatory impact on proposed delivery systems and / or digital health development plans
- Anticipates and resolves key technical or operational issues that have the ability to impact the function or product team.
- Participates in risk-benefit analysis for regulatory compliance
- Networks throughout Global Regulatory Affairs, as appropriate, building awareness and alignment on Regulatory Delivery Systems and / or Digital Health strategies.
- Provides regulatory guidance to product teams and implements regulatory strategies that result in successful product registrations.
- Exhibits strong leadership behaviors and is sought out as a functional mentor
- Incorporates new regulations, guidance, and company positions into GRA-Devices processes/guidelines, tools, and/or training materials
- Influences internal policy development and provides internal input on emerging regulations worldwide for device issues
- Participates in industry organizations to increase Lilly’s visibility and influence of evolving regulatory positions
Lead / Partner
- Leads preparation, review and finalization of device documents for global CTA and registration submissions and response to questions.
- Takes a proactive leadership role in the critical review of device specific development strategies and submission content.
- Makes decisions on regulatory strategies impacting product submissions across geographies and networks for alignment with Team members.
- Proactively identifies and resolves global device regulatory issues, leveraging internal experts and/or management to develop complex regulatory strategies
- Develop relationships with personnel in other Lilly functional areas that promote open discussion of issues demonstrated ability to influence drug and / or device development strategies.
- Communicates effectively verbally and in writing to influence within work group/function and with development team
- Participate in forums that share regulatory information across GRA components
- Participates in the development of corporate positions on, and responses to, proposed agency regulations and guidelines
- Bachelor’s Degree in sciences or engineering discipline (e.g. chemistry, biology, biochemistry, pharmacy, engineering or related scientific discipline)
- Medical Device or Pharmaceutical industry experience in technical drug and / or device development (7 – 10 years)
- Prior experience authoring submission content
- Prior Regulatory experience (3 – 5 years) or equivalent combination of technical and regulatory guidance knowledge
- Demonstrated strong written, spoken and presentation communication skills
- Demonstrated negotiation and influence skills
- Demonstrated attention to detail
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
Additional InformationLilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID 54367.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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