- Merck & Co. (Rahway, NJ)
- …injection.-- Job descriptionThis position will be responsible for leading and implementing medical device and combination product design controls for both new ... types of engineering plus 10 years of related experienceHas broad knowledge of medical device development, design controls and risk managementLed and managed… more
- Merck & Co. (Rahway, NJ)
- …expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on ... launch. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design,...Product Working Groups to ensure full integration of the device development activities with the clinical, regulatory ,… more
- Merck & Co. (Rahway, NJ)
- …Reporting to the Director responsible for this area, you will partake in medical device assembly and process development using semi-automated and automated ... as needed. Key Responsibilities: Experience with, and a fundamental understanding of medical device assembly equipment to enable development of product specific… more
- Aequor (Thousand Oaks, CA)
- …Client yet practical solutions to meet those needs Experience with combination products and device regulatory requirements and medical device development ... and engineering Preferred Traits: Passion for proactively identifying opportunities through creative modeling and data analysis Transform ambiguous business and technical questions into measurable and impactful projects Partner with multi-discipline digital… more
- Merck & Co. (Rahway, NJ)
- …cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …failures.Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for ... retention, testing and retesting of samplesProject Team Participation: Provide device -specific regulatory insight/guidance during CDx Indication Team Working… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of experience in GxP-regulated IT system implementation, validation, and compliance in pharma/biotech/ medical device industry - Required 4+ years of proven ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Merck & Co. (Rahway, NJ)
- …advanced degree (Master's or PhD) preferred.Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years ... role.Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly,… more
- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Durham, NC)
- …Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination ... and compliance requirements governing development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU Medical Device … more
- Merck & Co. (Rahway, NJ)
- …to commercialization. -Our development teams ensure robust composition, primary packaging/ device , and process selection through deep fundamental understanding and ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes medical treatments, customer solutions, and devices across multiple Therapy Areas ... driving customer impact by overseeing 5D efforts including Data, Diagnostics, Drug, Device , and Digital strategy and execution for relevant TAs, aligned closely with… more
- Eisai, Inc (Nutley, NJ)
- …with 3+ years experience in two or more of: infusion, diagnostic, biologic, medical device , buy and bill, rare disease, specialty pharmacy, and/or neurology; ... systems (including buy & bill, specialty pharmacy, distribution models, medical device and/or biologics experience) strongly preferred.Additional commercial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Brand teams, other functional teams in NNI (including MAPA), including marketing, medical , R&D, regulatory affairs, finance, NNGlobal, and other relevant ... go-to-market plan for devices for the brand portfolio (eg, single dose device , PDS290, pre-filled syringe), and maintaining strategic oversight of device -related… more
- Lundbeck (Fort Wayne, IN)
- …5+ years of Specialty Sales experience in Pharmaceutical, Biopharmaceutical, Biologics or Medical Device sales experience Ownership and accountability for the ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations… more
- Lundbeck (Waco, TX)
- …an accredited college or university 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Must ... resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies… more
- Lundbeck (Joliet, IL)
- …from an accredited college or university 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Eisai, Inc (Phoenix, AZ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... oral markets with approved indications, helping targeted customers, such as Medical Oncologists, Hematologists, Endocrinologists, and nurses, etc. learn about the… more
- Eisai, Inc (Boston, MA)
- …Area Business Leader- ADBachelor's degree with 10+ years of pharmaceutical, biotech, or medical device sales with 5+ years successfully hiring, developing, and ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... Experience** + 3-5 years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience + Experience with US FDA regulations (Title… more
