- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical ... to maintain best-in-industry regulatory compliance.The Vice President Regulatory Affairs, General Medicine is accountable for:Directing and Supervising the … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE) This role is primarily accountable for the end-to-end performance ... true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to… more
- Merck & Co. (Rahway, NJ)
- …time to approval by regulatory agencies.Independently manages projects within the General Medicine Therapeutic Area, functioning as the single, accountable, global ... and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …proceedings, IP counseling, manage prosecution of a portfolio of patents and patent applications in the US and globally, and provide legal support for licensing, ... on prosecution of a portfolio of patents and patent applications in the US and globally (as assigned), including...timely manner by the filing and prosecution of patent application (s) in the US and worldwide (in coordination with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …advanced input into study designs, analysis plans, and regulatory submissions/ applications Analyzes proposed study plans and related documents for their ability ... including investigational medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …research studies through the hands-on analysis of real world data and application of appropriate data science techniques under the minimal supervision of a ... surveys) Proficiency with statistical methods (eg, causal inference, survival analysis, general linear models, etc.); machine learning experience welcome, though not… more
- Merck & Co. (Durham, NC)
- Job Description GENERAL SUMMARY :The Sr. Tech, Engineering is a member of the Engineering team providing technical support to the manufacturing site. The site ... with operations, quality, automation, technology, and other groups as required. GENERAL PROFILE: Ability to perform routine maintenance tasks, work with and… more
- Catalent (St. Petersburg, FL)
- …problems with minimal guidance.Proficient to advance skills in Microsoft Office applications (Word, Excel, PowerPoint and Access)Working knowledge of cGMPs and/or ... perform the essential functions. This job description reflects the general duties of the job but is not a...you require reasonable accommodation for any part of the application or hiring process due to a disability, you… more
- Eisai, Inc (Nutley, NJ)
- …regional security vendors.Prioritize risk-based reduction efforts.Manager investigations. General Compliance Activities:Maintain an inventory of regulatory, ... knowledge of GAMP practices, familiarity with ISPE practices, and application of GxP standards.Industry-related legal, compliance, information security, or business… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …n/a Essential Functions Support of client hardware, standard software, and local applications Oversees all tickets originated from Site New Hampshire, focusing on ... frequent asked questions, workarounds and problem resolution Training of general staff on usage of equipment and systems Perform...###. This contact is for accommodation requests only and cannot be used to inquire about the status of applications… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the accuracy, neatness, and thoroughness of work assigned or to make general observations. Development of People Ensure that reporting personnel have individual ... goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo… more
- Merck & Co. (Durham, NC)
- …several tasks in parallel.Demonstrated mechanical aptitude.Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used ... maintenance, troubleshooting, and problem-solving skillsProficiency in computer systems and applications including but not limited to, Microsoft Office (Word, Excel… more
- Merck & Co. (Durham, NC)
- …safety and environmental requirements/regulations/guidelines Proficient in the use of general hand and power tools, instruments and testing apparatus commonly ... in accordance with GMP manufacturing operations.Proficiency in computer systems and applications including but not limited to: -Microsoft Office (Word, Excel and… more
- Aequor (Davie, FL)
- …in a manufacturing environment within pharmaceutical. POSITION SUMMARY Under general supervision, performs advanced journey-level duties in reviewing specifications ... codes, regulations and regulatory requirements. Pharmaceutical principles, practices and applications . Principles and practices of qualification and validation. Techniques… more
- Merck & Co. (Durham, NC)
- …multiple priorities and advance several tasks in parallelProficient in the use of general hand and power tools, instruments, and testing apparatus commonly used in ... level - Walking, bending, crawling and stoopingProficiency in computer systems and applications including but not limited to:- Microsoft Office (Word, Excel and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Provide legal counsel to global healthcare company on relevant issues involving application of US law, regulations, and industry standards. Relationships Reports to ... a Managing Assistant General Counsel. Acts as Counsel on the Clinical Commercial...###. This contact is for accommodation requests only and cannot be used to inquire about the status of applications… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functional areas in Research and DevelopmentFamiliarity with the challenges and general application of mathematical modeling/simulation in pharmaceutical R&D ... (MDT), a formal cross-functional framework for collaborative development and application of QSP within Oncology/Immuno-Oncology. ResponsibilitiesDevelop and apply Quantitative… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …awareness of current issues and new data pertaining to NNI products/global trends/ general market, b) develop and maintain relationships with health care providers, ... goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Ability to take on multi-disciplined projects, with minimal supervision Functional understanding/ application of quality systems with the ability to manage Change ... neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of...###. This contact is for accommodation requests only and cannot be used to inquire about the status of applications… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evaluation reports (CER) Pediatric investigational plans (PIP) Orphan Drug applications Breakthrough Therapy Designation requests Clinical summary and overview ... support as needed Provides support and training to others in the department General Tasks: Interprets and accurately presents clinical and statistical data in a… more
