- Eisai, Inc (Chicago, IL)
- …implement recommendations for resolution.Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)Technical Skills RequiredAdvance working ... Submission Heads for additional support for resources when needed. Provides the Regulatory Submission Management for a lead compound or submission project… more
- 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)
- …standards. + Team Leadership and Development: + Lead and mentor the oncology solid tumors medical affairs team, fostering a high-performance culture and ... goals. The role will involve close collaboration with clinical development, commercial, regulatory affairs , and market access teams to ensure alignment of… 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
- 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
- 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 (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 (Mettawa, IL)
- …Key responsibilities include: + Contributes to the development of brand strategies. + Lead and support Medical Affairs initiatives (strategy and tactics) for ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...regulatory , etc.) as they relate to on-going medical affairs projects. + Works with some supervision and guidance.… 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 (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 ... or research activities across several clinical development programs. May lead cross-functional teams to generate, deliver, and disseminate high-quality clinical… 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
- 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)
- …team, alliance partner, Market Access, Global Marketing, CI, Sales, Training, Regulatory , Legal, Medical Affairs , and agencies. Specific responsibilities will ... **XTANDI Commercial Brand Strategy Lead ** Do you want to be part of...and internal colleagues from other departments (including global, medical affairs , market research, legal, and regulatory ) as… 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)
- …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 (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)
- …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
