Post-Doctoral Regulatory Affairs Fellow - Policy and Intelligence at Boehringer Ingelheim
Ridgefield, CT 06877, USA -
Full Time


Start Date

Immediate

Expiry Date

30 Nov, 25

Salary

0.0

Posted On

01 Sep, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Requirements, Consideration, Developments, Computer Skills, Policy Management, Regulatory Affairs, Drug Development, Multiple Therapeutic Areas, Regulatory Compliance, Preparation, Excel, Custom Reports, Regulatory Policy, Corporate Structure, Strategy

Industry

Pharmaceuticals

Description

DESCRIPTION

The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to - Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require the Fellow to develop competencies necessary to contribute to their respective functional area within a pharmaceutical company. The Fellow will be based at Boehringer Ingelheim´s U.S. headquarters in Ridgefield, CT, working on a particular or multiple therapeutic areas (TAs) in the areas of cardiology, diabetes, immunology, oncology, and respiratory. Through a series of rotations either within or outside of the assigned area, the Fellow will also gain an understanding of the broad range of opportunities available to a pharmacist in the pharmaceutical industry. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
The Regulatory Policy and Intelligence Fellowship is designed to provide pharmacists with exposure to regulatory intelligence and policy activity within the pharmaceutical industry. The position will also offer the opportunity to complete rotations in areas within and beyond Regulatory Affairs.
The Fellow will be exposed to projects involving both US marketed products and investigational projects. Under supervision, the Fellow will:

• Develop, compile, and integrate regulatory intelligence from health authorities, professional groups, publicly available information and BI. • Appropriately communicate regulatory intelligence within the organization.

  • Provide analysis, advice, and guidance on US regulatory strategies to promote expedited product development and approval.
  • Research information on regulatory policies and departmental policies within and external to RA.
  • Research and implement processes to improve regulatory intelligence and collaboration.
  • Develop expertise on projects from the regulatory intelligence and policy perspective.
  • Collaborate with BI Government Affairs to ensure knowledge sharing of overlapping intelligence topics.

REQUIREMENTS

  • Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned prior to the start date at Boehringer Ingelheim.
  • Ability to perform MEDLINE and EMBASE literature searches.
  • Strong intrapersonal, active listening, and problem-solving skills with an ability to work well in a team environment.
  • Highly motivated and shows initiative in contributing to team deliverables.
  • Receptive to receiving and quickly implementing constructive feedback.
  • Ability to work independently within provided guidance from team leads.
  • Adaptable and able to contribute to multiple Therapeutic Areas as needed.
  • Excellent verbal and written communication skills.
  • Proven experience working in a dynamic, high volume environment handling multiple tasks.
  • Strong computer skills, including Outlook, Word, PowerPoint, and Excel.Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy with an ability to quickly adapt to a changing Corporate environment that will allow the incumbent to be productive in rotational experiences.
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Desired Experience, Skills, and Abilities:

  • Prior pharmaceutical industry experience (e.g. internship or Advanced Pharmacy Practice Experience [APPE] rotation is preferred but not required.
Responsibilities

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