- Genmab (Princeton, NJ)
- …(Associate) Director of Biostatistics acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both ... people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we...targeted therapies, and companion diagnostics preferred Experience working with FDA , EMA, and ICH guidance for drug development… more
- Schwan's (Salina, KS)
- …our delicious Red Baron and Tony's products are made. This is an opportunity to lead our most complex facility, which spans over 500K sq feet, employs 900+ team ... meets established standards and that costs are within budget. Assists in the development of and implementation of capital plans related to production improvement or… more
- Leidos (Reston, VA)
- **Description** Leidos Health Solutions has an opening for a ** FDA Business Development Lead .** The ** FDA Business Development Lead ** is ... and monitor competitor activity. You will collaborate with a team of business development professionals, including capture managers, BD leads and BD… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** **Associate Director, Process Development Lead - Data Science:** Recently, Gilead launched an ... into use case investments across the company. The Process Development Lead will be responsible for designing,...Ensure processes comply with relevant regulations and standards (eg, FDA , EMA) and comply with Good Manufacturing Practices (GMP),… more
- Lilly (Indianapolis, IN)
- …(patient, provider and payer). To effectively partner and support the needs of the US Business Unit, the Sr. Director will lead a team of regulatory personnel, ... High quality, timely and decisive regulatory advice to allow business partners to make well-informed decisions + Development...controls, and quality review of promotional material submissions to FDA . + Attend US Business Unit meetings… more
- Bristol Myers Squibb (Princeton, NJ)
- …strategic direction and provide leadership for all regulatory interactions with FDA /global regulatory authorities + Lead regulatory dossier submissions to ... laws, regulations, and guidelines as they apply to US FDA for drug development and approval. +...to work successfully in a matrix environment and to lead teams successfully toward drug approvals Other Qualifications: +… more
- TestPros (Silver Spring, MD)
- …systems and data are protected from potential threats. Key Responsibilities: + Lead the development and implementation of cybersecurity strategies and protocols ... Company Overview TestPros is a successful and growing business , established in 1988 to provide Information Technology (IT) technical support services to a wide range… more
- ICF (Reston, VA)
- …resolution between the two teams. + **Corporate Growth:** Contribute to the growth of the business . Lead the development of client roadmaps to identify and ... 100% remote work anywhere within the US. As a ** Lead ** **ServiceNow (HRSD) Business Process Consultant,** you...of experience in technical skills, including workflow configuration, and business rule development . + 1+ Years of… more
- IQVIA (Parsippany, NJ)
- …to maintain compliance throughout study conduct. + Participates in strategic business development activities including presentations to prospective clients and ... that meet regulatory standards and exceed client expectations. + Lead the development of proposals and provide...professional meetings. + Maintains awareness of industry pipeline and FDA regulations and guidance, scientific and business … more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …preparation including principles, terminology and methodology. Good knowledge of the Clinical Development process, including knowledge of ICH GCP, FDA GCP, and ... preparation including principles, terminology and methodology. Ability knowledge of the Clinical Development process including knowledge of ICH GCP, FDA GCP, and… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director, North America Regulatory Lead - 2406196976W **Description** Johnson & Johnson Innovative Medicine is recruiting for Associate Director, North ... America Regulatory Lead in Global Regulatory Affairs, supporting programs in the...Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values… more
- Sanofi Group (Bridgewater, NJ)
- …and at least 14 weeks of gender-neutral parental leave. + Lead the development of evidence strategies that shape key business decisions and drive the future ... **Real World and Consumer Evidence Lead , North America** Location: Morristown, NJ At Sanofi...a force for good by integrating sustainability along our business and employees' mission and operate responsibly from both… more
- Abbott (Abbott Park, IL)
- …your true self and live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + ... and on-site technical support including instrument repair for complex issues. + Lead when necessary, implementation of new automation projects + Mentor and provide… more
- Kohler Co. (Palo Alto, CA)
- **QA Lead Software and Regulatory - Kohler Ventures** _Work Mode: Hybrid_ **Location:** Hybrid 3 days/onsite in Palo Alto, CA **Opportunity** Kohler Ventures is an ... Our mission is to build new digital businesses that empower consumers to lead healthier lives. We explore how familiar experiences can be enhanced and innovations… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and ensures cross-functional alignment with overall development plan. + Is assigned as lead contact with FDA and Health Canada or delegated to direct reports ... development , sales, marketing, medical affairs, supply chain,and business development functions. MTPA is dedicated to...Serves as primary contact for assigned projects with the FDA and Health Canada for development projects:… more
- Novo Nordisk (Princeton, NJ)
- …20% overnight travel required. May require occasional work outside of standard business hours to support special requests/events. Development of People Ensure ... interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …opportunities working closely with colleagues in the US and global business development teams. + Participate in and lead cross-functional teams to conduct ... research, clinical development , sales, marketing, medical affairs, supply chain,and business development functions. MTPA is dedicated to improving the… more
- University of Washington (Seattle, WA)
- …to spearhead and coordinate development and updates to policies and processes. + Lead or be involved with work groups and/or action teams that are formed to ... of Sponsored Programs has an outstanding opportunity for a Senior Contracts Specialist, Team Lead , on the Contracts team. This position will be part of a unit within… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …and overseeing contributions from a diverse set of proposal team members. The Senior Business Development Specialist will also lead certain efforts to ... disabilities. **Brief Job Overview** USP seeks a new Senior Business Development Specialist to serve as a...from US Government funding agencies, such as USAID, CDC, FDA , and NIH, other bilateral funding agencies, multilateral organizations,… more
- WCG Clinical (Princeton, NJ)
- …, maintenance, and enforcement of the CSO Quality Management System. + Manage/ lead efforts with regard to the identification, development and maintenance ... experience in establishing and monitoring compliance standards across a business unit including analysis and tracking. + A minimum...and revise internal technology standards (ie IT and/or Software Development Policies, SOPs, et al). + Lead … more
