- Merck & Co. (Rahway, NJ)
- …activities. Prepare, review, and/or approve GMP Documentation as appropriate. Author /Approve Standard Operating Guidelines and Procedures. Support equipment and ... and collaborate with all building staff to share and align on best practices. Author lessons learnt through after action review summaries or other reports to capture… more
- Insmed Incorporated (Bridgewater, NJ)
- …safety data package, oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory ... potential impact of toxicology results on Program and Clinical/Regulatory strategy. Author nonclinical sections in regulatory submission documents (eg, IBs, INDs,… more
- Merck & Co. (North Wales, PA)
- …team; Biostats, Molecular Assay teams, -and other key LFs to author protocol-specific biomarker plans and ensure their efficient implementation.-Incorporate cutting ... and biomarker strategy.-Collaborate with clinical and companion diagnostic leads, author protocol-specific biomarker plans and ensure their efficient implementation.-… more
- Merck & Co. (Rahway, NJ)
- …with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co- author strategic documents. Please note, this position is ... open to remote work. To comply with applicable law, candidates based in Sweden and Switzerland are required to work on a hybrid schedule, spending 2-3 days in the office and cannot work fully remotely. Associate Directors are expected to have or be developing… more
- Authoracare Collective (Greensboro, NC)
- …personalized support for mind, body, and spirit.Our patients are always the author of their life story. During a challenging illness, AuthoraCare Collective helps ... them author more moments that matter, regardless of the stage of their illness or condition. This is captured by our tagline: Your Story. Our Expert Care.by Jobble more
- Merck & Co. (Durham, NC)
- …3rd shift work if needed based on experimental designs or customer needs. Author and present experimental design proposals, technical reports and documents to peers ... and stakeholders.Compile process and analytical data, and employ statistical tools for experimental analysis and process monitoring.Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to vaccine… more
- Merck & Co. (Durham, NC)
- …start-up, commissioning, qualification through licensure and ramp up of facility. Author , review, and/or edit operations and technical documentation (Batch Records, ... SOPs, Job Aids, training, and engineering documents) to support project and ongoing operations. Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while coordinating with appropriate personnel. Actively… more
- Merck & Co. (Durham, NC)
- …and/or continual process improvement. Authoring and reviewing documents and SOPs. Author deviations and works to coordinate, develop and implement Corrective ... Actions/Preventive Actions (CAPAs). Ensuring visibility and accuracy of the project schedule and update dashboards accordingly to highlight the project status of critical milestones. Ability to effectively support, upskill and mentor new employees Analyzing… more
- Merck & Co. (Durham, NC)
- …departments to ensure appropriate root cause and CAPAs are determined . Author /revise SOPs, methods, protocols, and trend reports .-Provide support to all Quality ... related audits from external and regulatory agencies .-Identify Continuous Process Improvements to maximize efficiencies and streamline processes within the QualityRequired qualifications: Education Minimum Requirement: Bachelor of Science degree in Biology,… more
- Merck & Co. (Rahway, NJ)
- …operations, process development activities, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of ... our enabling facilities.Additional Supported AreasAs required and in addition to support of the MACS facility the Associate Director may need to provide direct support of the other areas such as: Small Scale Organics Pilot Plant (SSO ):- The SSO is a Good… more
- Merck & Co. (North Wales, PA)
- …his/her area of responsibility.-To accomplish these goals, the Director may: Author detailed development documents, presentations, budgets, and position papers for ... internal and external audiencesManage a complex matrix of internal stakeholders within clinical development (ie across existing PDTs and TAs) and across functions-Facilitate collaborations with external researchers around the world-Travel on company business… more
- Merck & Co. (Rahway, NJ)
- …This role may support facility operations, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our ... enabling facilities. Additional Supported Areas: As required and in addition to support of the Prep Lab the Specialist may provide direct support to other areas such as:Small Scale Organics Pilot Plant (SSO): - The SSO is a Good Manufacturing Practice (GMP)… more
- Merck & Co. (Rahway, NJ)
- …in his/her area of responsibility.To accomplish these goals, the Director may: Author detailed development documents, presentations, budgets, and position papers for ... internal and external audiencesFacilitating collaborations with external researchers around the worldTravel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects. QualificationsEducation:M.D or… more
- Merck & Co. (Rahway, NJ)
- …responsibility. To accomplish these goals, the Senior Clinical Director may: Author detailed development documents, presentations, budgets, and position papers for ... internal and external audiencesFacilitate collaborations with external researchers around the worldTravel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects. Qualifications Education MD, DO,… more
- Merck & Co. (Durham, NC)
- …continuous process improvements initiatives related to compliance, efficiency, and cost. Author , review, and/or edit operating procedures and training documents to ... support operator training qualification and production execution. Provide post approval support and subject matter expertise support to ongoing manufacturing activities. Working Relationships: Reports to the Director of Operations Facilitates Purification… more
- Merck & Co. (Rahway, NJ)
- …in the program-specific design controls process and design history file development. Author and review relevant portions of the regulatory submissions (INDs, IMPDs, ... NDAs, BLAs, etc.) for combination product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards.Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance of the proper interpretation of statistical analysis results; Review or co- author the value dossier and scientific communications. Ensure timely, to budget ... and accurate completion of Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert in meeting or teleconferences with Health Authorities. Ensure… more
- Lundbeck (Bothell, WA)
- …for all development programs (from early to late phase clinical development) Author and review SOPs, development reports, and technical reports In partnership with ... QC, serve as the Subject Matter Expert (SME) in the transfer of analytical methods from Lundbeck to GMP contract labs/contract manufacturing organizations (CMOs) Collaborate with QC to ensure successful method validation at contract labs/CMOs; support… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …deviations that occur in operations and perform technical writing of investigations Author and manage the investigations to meet key timing commitments, with ... well-investigated and well-documented deviation reports Provides consistent direction and ensures timely completion of deviation investigations to ensure ongoing consistency for investigation reports that will stand alone during regulatory inspection through… more
- Aequor (Thousand Oaks, CA)
- …liquid, lyophilized, etc.). Data analysis and documentation/review in electronic notebooks. Author , review, and data verify technical documents such as protocols, ... reports, regulatory documents, etc. Clearly and consistently communicate data in progress reports and presentations. Participate in cross-functional teams in a fast-paced environment to progress product development. Adhere to all training, compliance, and… more
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