| Our Culture At Boehringer Ingelheim, we deliver Value through Innovation by living our fundamental principles of Lead & Learn. We have high expectations for our employees. We require employees at all levels of the organization to take initiative, stay connected, grow together, and achieve outstanding results. To enable high performance, we provide opportunities for personal growth, a collaborative and inclusive work environment, and exceptional employee benefits. We reward high achievement with recognition, opportunities and competitive pay. We hold ourselves to the highest standard of excellence and count on each other to go the extra mile in everything we do.
DRA Product Specialist II, DRA Product Labeling
As a DRA Product Labeling Specialist, you will independently conduct revision, tracking, and proofreading activities for BIPI late-development and marketed product labels/labeling as required by FDA regulations, BI Corporate Design, and other local processes to ensure that assigned labeling submissions are prepared and submitted within established timeframes. Proactively interact with DRA Product Managers, DRA Product Maintenance/Compliance, the Graphics Office, and external vendors for guidance on timelines and technical activities. Independently manage multiple labeling projects with minimal supervision. Serve as a mentor for Specialist I and liaison with DRA Product Maintenance/Compliance. Provide training on specialized labeling activities for contributors. Demonstrate independence and proactive capability to streamline existing processes and as new FDA initiatives emerge, develop new business processes with associated training. 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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees. Responsibilities:
Bachelor’s degree preferred, ideally with a science background; minimum of five to seven years pharmaceutical industry experience with five years in a regulatory environment; or Associates degree preferred with 10-12 years pharmaceutical experience of which five years in a regulatory environment. Minimally requires five years experience specialized in pharmaceutical labeling position, regardless of educational background.
- Interact with cross functional teams to develop, review, and finalize labeling components.
- Understanding the FDA regulations and how they apply to pharmaceutical labeling is essential for this duty. Able to mentor/train others on requirements and to evaluate the impact of emerging labeling initiatives from BI and/or FDA. Attends at least one workshop/conference to gain further insights applicable to the required duties and shares insights with the Product Labeling Group.
- Participate in drafting and review of applicable Standard Operating Procedures (SOP) and Working Instructions (WI) for labeling related activities.
- Performs special projects as assigned.
- Acts as decision maker in absence of Associate Director, DRA Product Labeling.
Requirements:
- Extensive knowledge of FDA regulations/guidances regarding labeling requirements, demonstrating high proficiency in interpretation of evolving requirements. High level of experience and knowledge of Structured Product Labeling (SPL).
- Ability to work in a team environment with personnel in and outside DRA.
- Ability to perform diverse and complex tasks including experience with complex database applications used for monitoring labeling lifecycle. High level computer literacy and able to adapt promptly to change.
- Excellent proofreading/editing skills; excellent usage of the English language (spelling, grammar, and punctuation); excellent communication skills; the ability to work well under pressure and adapt to changing priorities.
- Excellent organizational, planning and follow-up skills. Able to meet tight timelines, efficient, detail oriented with knowledge of medical and regulatory terms, flexible and self-starting. Must have basic problem solving skills, both from a technical and procedural perspective. Ability to multi-task projects.
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