- 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
- AbbVie (Mettawa, IL)
- …specialist medical and scientific input into core strategic and operational medical affairs activities for AbbVie's Oncology portfolio such as: health-care ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- Astellas Pharma (Northbrook, IL)
- …are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States ... frameworks and global CMC strategy. This role will lead the development and execution of innovative regulatory...position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing… 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 R&D Regulatory Affairs Finance team supports the leadership in strategic ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...(Long Range Plan) and Latest Best Estimate (LBE) for Regulatory Affairs . The primary function of the… 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
- Astellas Pharma (Northbrook, IL)
- …with all levels of internal stakeholders and key functional areas including, Regulatory Affairs , Medical Affairs , Clinical Operations, Data Sciences, ... indications within the division. This position will work closely with the Global Medical Lead (GML), Operations Lead , Asset Lead , and Development Physician.… 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 ... of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver and disseminate high-quality clinical data… more
- Veterans Affairs, Veterans Health Administration (North Chicago, IL)
- …from a cost and patient outcome perspective. Provides direct pharmacist- lead specialty clinics and/or services. Responsible for the development, implementation ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Complete all application requirements detailed in… 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
- 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)
- …trials within a given late phase program or multiple early-phase programs in the Immuno- Oncology group. + Reports to the Medical Lead /disease area strategy head ... Clinical Pharmacology, Biomarker, medical safety, Toxicology (early phase programs) regulatory , biostatistics, medical affairs , Health Economics, commercial… more
- Astellas Pharma (Northbrook, IL)
- …Global Brand Strategies. + Identify medical data gaps based on SWOT analyses lead Medical Affairs scientific initiatives, participate in Medical Legal Review ... expertise. Through three diverse rotations-Clinical Development (12 months), Medical Affairs (6 months), and Pharmacovigilance (6 months), Participants will gain… more
- AbbVie (North Chicago, IL)
- …disciplines to advance medicines to our patients. Responsibilities + Provide expertise/ lead regulatory submission and product life-cycle management strategy ... needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements. + (SSG) Lead statistical support for benefit-risk… more
- AbbVie (North Chicago, IL)
- …In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs , the appropriate regulatory strategies for ... Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs , Research and Development. Additional Information Applicable… more
- AbbVie (Mettawa, IL)
- …along the way. + As a key liaison with International Medical, Legal, OEC and Regulatory Affairs (MLOR), ensure all digital patient solutions remain up to date ... 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)
- …analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs , supply chain and Operations Manufacturing Sites. ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...a motivated Scientist as a CMC drug product project lead , specifically for parenteral drug product process development and… 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 ... strategy formulation within a collaborative, cross-functional environment. Key Responsibilities: + Lead the planning and execution of analytics to inform market… more
- AbbVie (Chicago, IL)
- …(MSLs) in a therapeutic region. The FD reports to a therapeutic Field Medical Lead and works cross-functionally within US Medical Affairs to identify, develop, ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...business objectives within a therapeutic area of US Medical Affairs . This includes, but is not limited to, coaching… 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 ... of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data… more