- Merck & Co. (Rahway, NJ)
- …Specialty Products (SSP) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large ... should have experience authoring regulatory filings for sterile dosage forms especially biologics (liquid/ lyophilized/ complex systems).The candidate should have… more
- Aequor (Salt Lake City, UT)
- …corrective actions. 7. SOPs and Document Review: Write, revise, and review SOPs, forms , and work instructions for accuracy and GMP compliance. 8. Additional Duties: ... Responsible for writing, revising or reviewing Standard Operating Procedures (SOP's), forms and/or Work Instructions with changes of low complexity and responsible… more
- Merck & Co. (Rahway, NJ)
- …the Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large ... sterile products across injectable, implantable, ophthalmic, and inhaled dosage forms .Provide active strategic and technical leadership on program development teams,… more
- Merck & Co. (North Wales, PA)
- …validate as required, study design, protocols, measurement questionnaires, case report forms , data analysis plans, and final reports/publications.Works with the our ... Research documents such as local research protocols, and design data collection forms , in collaboration with our Company affiliates and according to local… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …list. Responsible for the filing of Data Management coding documentation and approval/signatures forms in the TMF (Trial Master File) on an ongoing basis according ... for the filing of final Data Management coding documentation and approval/signature forms in the TMF according to applicable Daiichi Sankyo and regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support of all equipment and process support installations. A solid maintenance plan forms the basis to make the performance and behavior of the equipment more ... support of all equipment and process support installations. A solid maintenance plan forms the basis to make the performance and behavior of the equipment more… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …production record issuance information into the batch tracking log.Obtains the required forms associated with each stage of manufacturing.Sorts and stages the batch ... production records and forms for autoclaving (as applicable)Distributes the prepared batch production record to manufacturing designates.Reconciles cancelled batch… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …approximately 37.5 hours per week. Responsibilities: -Review clinical study informed consent forms (Master, country and site level) and capture key information in an ... document used by the Biosample Management team to design informed consent forms for future studies-Present the findings to relevant stakeholders to highlight some… more
- Novo Nordisk Inc. (Boulder, CO)
- …level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all ... reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way. Qualifications Bachelor's or more… more
- Genmab (NJ)
- …experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.About YouYou are passionate about our ... purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a… more
- AUROBINDO (Durham, NC)
- …is requiredExperience with dermatological, transdermal, and/or inhaled dosage forms is preferableKnowledge and use of Good Documentation practicesKnowledge ... of USP/ICH/FDA guidelinesAbility to learn quickly and having decision making skillsEducation & ExperienceBS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable Physical RequirementsLAB TECHNICIANS - Must be able to bend at the waist and… more
- Genmab (Plainsboro, NJ)
- …experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.About YouYou are passionate about our ... purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a… more
- Genmab (Plainsboro, NJ)
- …experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.About YouYou are passionate about our ... purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a… more
- Merck & Co. (Rahway, NJ)
- …is a multidisciplinary research group responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large ... molecules from preclinical toxicology studies to commercialization. -Driving drug product design from the bench to manufacturing facilities, our teams ensure robust product design and development through deep fundamental understanding and characterization… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the payroll staff.Oversees wage garnishment requirements by completing forms ; adjusting payroll records, documenting and transmitting withholdings; negotiating ... with collection agencies to convert garnishments to wage assignments.Closely works will the Equity Team to manage a complex process to properly pay and tax LTI awards- Oversees and manages staff to accurately and timely process all payroll runs. Reviews and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …less complex Module 1 regulatory documents (eg cover letter, FDA forms , administrative information, letter of authorization, etc.) for US regulatory submissions ... and may be involved with preparation of more complex Module 1 documents if delegated by the USRA strategistWorks independently, predicts the needs for the GRL and GRT rather than being directed and helps drive coordination of regulatory activities.Supports GRL… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all ... reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way. Qualifications A Bachelor's degree is… more
- Twist BioScience (South San Francisco, CA)
- …documents, Section 16 filings, Registration Statements (S-1, S-8, and S-3), and Forms 10-Qs and 10-KsSupport Board and Committee meetings, including the drafting, ... preparation and review of Board meeting materials, minutes, and D&O questionnairesSupport Twist's annual stockholders meetingSupport Investor Relations by reviewing press releases, earnings releases, investor presentations, and other materialsAdvise on equity… more
- Twist BioScience (South San Francisco, CA)
- …Documenting as-is and to-be states of business areas in the forms of diagrams (workflow diagrams, entity relationship diagrams, functional decomposition diagrams), ... prioritization matrices, business requirements documents, and technical requirements documents.Perform structured analyses of business requirements to facilitate new insights and mitigate project risks.Perform object-oriented analyses to abstract and… more
- Genmab (Plainsboro, NJ)
- …experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.About YouYou are passionate about our ... purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a… more
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