- Astellas Pharma (Northbrook, IL)
- …of commercial products within a within a region. + Responsible to be a Regional Regulatory lead or Global Regulatory Lead , for development programs ... Leads regulatory development in GRL or regional regulatory lead roles in the context of...Supports an environment to enable each member of the Regulatory Affairs team to optimally operate in… more
- Danaher Corporation (Deer Park, IL)
- …in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in ... m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for regulatory… more
- AbbVie (Mettawa, IL)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... of the US Advertising and Promotion (USAP) department including the Regulatory review of non-promotional materials, providing operational guidance and development of… more
- AbbVie (Mettawa, IL)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Area TA Lead will act as the Intercontinental Neuroscience Lead , providing… more
- AbbVie (North Chicago, IL)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation… more
- AbbVie (Mettawa, IL)
- …MM will foster positive working relationships with the sales force, medical affairs , market research, sales training, regulatory , competitive intelligence, and ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...have direct reports but must demonstrate the ability to lead without authority and build a collaborative and integrated… more
- AbbVie (North Chicago, IL)
- …team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs , and Medical Writing. Safety Statisticians ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...+ Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory… more
- AbbVie (Mettawa, IL)
- …They will foster positive working relationships with the sales force, medical affairs , market research, sales training, regulatory , and other cross franchise ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...have direct reports, they must demonstrate the ability to lead without authority and build a collaborative and integrated… more
- AbbVie (Mettawa, IL)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... for the department. Responsibilities + Serves as medical writing lead on more complex writing assignments. Works closely with...required or in a related area such as quality, regulatory , publications, clinical research, or product support/R&D. + 2… more
- Astellas Pharma (Northbrook, IL)
- … regulatory compliance and timely submissions. + Partner with drug regulatory affairs , clinical trials unit, clinical development, precision medicine teams, ... across all phases of drug development. As a Diagnostic Regulatory Strategy Lead , you will be the...relevant scientific or technical discipline (eg, Life Sciences, Pharmacy, Regulatory Affairs ). Advanced degree is preferred. +… more
- Astellas Pharma (Northbrook, IL)
- …in remote work are encouraged to apply. **Purpose and Scope:** The Global Statistical Lead (GSTATL) for Solid Tumor Oncology is a compound level leader within ... Accountabilities:** Strategic Statistical Leadership + Serve as the compound-level statistical lead for solid tumor oncology , responsible for end-to-end… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director, Regulatory Affairs Global Regulatory Strategy is responsible ... secure and maintain market approval for product(s) in the Oncology therapeutic area. Leads the Global Regulatory ...Sr GRL or TA Head. May participate in or lead regulatory and company initiatives. Based on… more
- Astellas Pharma (Northbrook, IL)
- …in remote work are encouraged to apply. **Purpose and Scope:** The Medical Lead Oncology , MA-US (Medical Affairs -United States), is accountable for ... more products within the Therapeutic Area (TA). The Medical Lead Oncology , MA-US is responsible for: +...insights into regional and global strategy + Collaborate with Regulatory Affairs and Pharmacovigilance in the development… more
- AbbVie (North Chicago, IL)
- …driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** The Therapeutic Area Lead , Early Scientific Engagement & Communications, will lead the strategic ... communications for Astellas early-stage assets, ensuring alignment with the broader oncology and biopharma portfolio strategy. Reporting to the Head of Early… more
- Astellas Pharma (Northbrook, IL)
- …deliverables. This position is expected to develop a reliable network of academics, regulatory experts, and industry peers, and lead the research area as ... in remote work are encouraged to apply. **Purpose and Scope:** This Statistical Scientist Lead in the Innovative Statistical Science group is expected to act as an… more
- AbbVie (North Chicago, IL)
- …(Discovery to Development), Toxicology (early & GLP), DMPK, Discovery Biology, Regulatory Affairs , Clinical Pharmacology, Biostatistics, QA, and Business ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- AbbVie (North Chicago, IL)
- …scientific research programs; for generating scientific evidence to support medical affairs strategies; and for interacting with regulatory agencies, medical ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...to Lake County, IL or Florham Park, NJ Medical Affairs & Health Technology Assessment (MA&HTA) Statistics is responsible… more
- AbbVie (Mettawa, IL)
- …strategies. + Provide substantive advice across departments including Marketing, Sales, Medical Affairs , Regulatory Affairs and others concerning a broad ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- AbbVie (North Chicago, IL)
- …more clinical development projects through own efforts or those of a team. Lead /develop statistical strategy for project development and regulatory submission. + ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more