- Parexel (Providence, RI)
- **Job Title:** Data Management Lead (Medical Affairs) - Oncology **Location:** Fully Remote (US based) Must be able to accommodate West Coast hours. **About ... supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion… more
- Parexel (Providence, RI)
- **Title: Principal Real World Research Delivery Lead (RWRDL)** **Location:** US - Remote Are you ready to take on a challenge and accelerate your career? This is an ... Parexel is seeking a **Principal Real World Research Delivery Lead (RWRDL)** to join our team and deliver innovative...adaptability, and a go-getter mindset. Experience in **RWD/RWE** , ** data privacy** , and **drug development** is a plus.… more
- Parexel (Providence, RI)
- …throughout a study's lifecycle, responsible for site start-up, activation, relationship management , recruitment, and quality assurance. This role also contributes to ... to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and mitigate risks. **Key Accountabilities** : **Site… more
- Cipla (Fall River, MA)
- …record. Review of engineering records such as temperature and humidity data calibration and PM records, pest control records and contractor related ... and qualification documents. Provide daily/weekly updates to shop floor and management regarding the quality highlights/concerns. Create lessons learned for training… more
- Cipla (Fall River, MA)
- …of product Prepare the facility and rectify issues related to facility management and documentation for audit readiness Handle investigations, OOS, OOT, change ... reviewing reports during shift performance dialogue Review the OOE data and monitor the PDCA system to minimize the...to volatile demand. Overcome by rescheduling of plans More lead time for approval of regulatory documents by internal… more
- Parexel (Providence, RI)
- …Provide medical safety expertise to client per request + Review and sign off Data Management line listings (including adverse events, laboratory data , vital ... as Subject Matter Experts (SMEs) + Assisting the Project Lead /Functional Lead for audits and inspections +... management tools, etc.) + Contribution to Safety Management Team (SMT) meetings: Data analysis/ review,… more
- Cipla (Fall River, MA)
- …any Pharmacopoeia are in effect. Review of laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating with the Analytical ... improvements in the identified areas. Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance.… more
- Cipla (Fall River, MA)
- …approach towards assessment of projects, project milestones and stage gate reviews. Lead and/or participate in conducting data and hypothesis driven ... contributor role that reports to the Director of Project Management , R&D, North America. The job duties for this...including QbD principles in all technical studies. Participate and/or lead technical due diligences on projects where Cipla is… more
- Cipla (Fall River, MA)
- …AM - 5:00 PM (May vary based on business needs) Reports To : QA QMS Lead Salary Range : $64,272 - $77,662 PURPOSE The QA Document Control Associate in a ... 11, ICH, and ISO. This role supports the Quality Management System (QMS) by maintaining accurate, secure, and accessible...Quality Team. The position reports to the QA QMS Lead and may be matrixed to other functional leaders… more
- Cipla (Fall River, MA)
- …in production workflows. Collaborate with Team, Quality, Supply Chain, Project Management , Engineering, and R&D teams to resolve operational bottlenecks Support ... enhancements. Support initiatives aimed at improving overall productivity through data analysis and performance reviews. Develop and maintain strong professional… more
- Cipla (Fall River, MA)
- …equipment and products in compliance with site SOPs and regulatory guidance. Provides data to support management evaluation of performance trends. Owns quality ... leads and manages projects to implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends… more
- Cipla (Fall River, MA)
- …knowledge of instruments such as Karl Fisher, HPLC, GC, Particle size, ICP Lead investigation activities. Ensure compliance to all data integrity and cGMP ... work in teams Ability to understand and analyze complex data sets. Working knowledge of Microsoft Office programs and...some weekends based on business needs as required by management . No remote work available No employment sponsorship or… more
- Cipla (Fall River, MA)
- …knowledge of instruments such as Karl Fisher, HPLC, GC, Particle size, ICP Lead investigation activities. Ensure compliance to all data integrity and cGMP ... work in teams Ability to understand and analyze complex data sets. Working knowledge of Microsoft Office programs and...some weekends based on business needs as required by management . No remote work available No employment sponsorship or… more
- Cipla (Fall River, MA)
- …standard operating procedures (SOPs). Review of laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating with the ... improvements in the identified areas. Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance.… more
- Cipla (Fall River, MA)
- …operating conditions. Review of engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor related ... customer complaints. Identify and report any non-conformances and/or discrepancies to management if applicable. Complete other duties or participate in project work… more
- Cipla (Fall River, MA)
- …skill testing. Participate in investigation activities. Ensure compliance to all data integrity and cGMP practices, procedures, and expect ensuring compliance with ... Chromatography (HPLC), Karl Fischer (KF), Dissolution,Particle Size and ICP. Lead Investigation activities Familiarity with Chromatography systems is required,… more
- Cipla (Fall River, MA)
- …leads and manages projects to implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends ... computer skills, specifically Microsoft Office Suite. Solid organizational and time management skills are required to prioritize activities in a manner consistent… more
- Parexel (Providence, RI)
- …with applicable regulatory guidelines, SOPs, and goals of submission. **Project Management ** + Operate as the project lead writer/submission coordinator ... clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of… more
- Cipla (Fall River, MA)
- …correctly implemented. Assist in the collection, analysis, and reporting of quality data (eg, quality metrics, CAPA (Corrective and Preventive Action) reports, audit ... Advanced vocational training or education in pharmaceutical manufacturing, industrial management , or related field of study from an accredited...believes that our biggest assets are the employees who lead us to prosperity and growth in the future.… more
- FM (Johnston, RI)
- …testing and maintain data integrity across all systems. + **Collaborate & Lead :** Partner with Product Owners, Architects, Analysts, and Data Scientists on ... research capability and engineering expertise are solely dedicated to property risk management and the resilience of its policyholder-owners. These owners, who share… more
