TOPIC: Workforce Development
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https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-37f9d61e4eba471b121cf447dc426189-ff-BioNJ-Logo_Outlines.png | Trial Sponsor | https://www.bionjtalentnetwork.org/ | My Article | lasdfkj asd f asd fa sdf asdj f;laskdjfo;aisfuaiew ;al a d al sdf a sdf a df a sdf as df as kja;sdlkfja;k esf;alks ;alksdjf ljad;lfkj a;lkdsj flaksdjf;l akjd f;lkajdf;lkajs flkadj. alkj;alksjd ;lkajsd;lkja ;lkja; lkj ;lakjsd;lfk ja;d j;alkjf;lkajs ; | ob Description Summary: The Research Associate I, Biology is responsible for performing scientific experiments that contribute to research and drug discovery activities at PTC. This position assists in the conduct of early-stage research, the goal of which is the identification of New Chemical Entities (NCEs), as well as the advancement of research programs from the identification of screening hits to advanced lead optimization. The incumbent is also responsible for communicating experimental results to his/her supervisor and the project team. The Research Associate I, Biology supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs) including as appropriate. Job Description: ESSENTIAL FUNCTIONS Primary duties/responsibilities:
Specific duties may also include, but may not be limited to, the following:
KNOWLEDGE/SKILLS/ABILITIES REQUIRED * Minimum level of education and years of relevant work experience.
* Special knowledge or skills needed and/or licenses or certificates required.
*Special knowledge or skills and/or licenses or certificates preferred.
Expected Base Salary Range $58K to $70K The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans. **At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position. EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. | |
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-7fa8f5711824755a925aa125c780c8b4-ff-logo.png | Trial Sponsor | https://www.bionjtalentnetwork.org/ | Dan's 2nd Initiative | Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initia | Job Description Summary: The Senior Scientist, GxP Bioanalytical, Clinical Pharmacology provides quantitative bioanalyses of biological samples in support of the clinical and/or preclinical development of small molecule products. This position uses analytical techniques including, but not limited to, Liquid Chromatography-Mass Spectroscopy (LC-MS) to develop and validate bioanalytical methods for small molecule programs. The selected candidate coordinates and executes in-house bioanalytical method development and validation to support clinical / preclinical projects for small molecules using LC-MS/MS. The Sr. Scientist also performs/coordinates sample analysis and interprets data and provides timely support to the broader development program(s) including regulatory submissions. The Sr. Scientist may also monitor and coordinate bioanalytical activities at Contract Research Organizations (CROs) in support of small molecule clinical and/or preclinical development. The analyses may include those governed by FDA or other global health authority regulations. The incumbent works cross-functionally with internal departments and external resources on bioanalytical method development, sample analysis and related activities. The Senior Scientist, GxP Bioanalytical, Clinical Pharmacology adheres to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Job Description: ESSENTIAL FUNCTIONS Primary duties/responsibilities:
KNOWLEDGE/SKILLS/ABILITIES REQUIRED * Minimum level of education and years of relevant work experience.
* Special knowledge or skills needed and/or licenses or certificates required.
*Special knowledge or skills and/or licenses or certificates preferred.
**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position. EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. | |
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-7fa8f5711824755a925aa125c780c8b4-ff-logo.png | Screening Processes | https://www.bionjtalentnetwork.org/ | Today's Inititive with Randi | Today's Inititive with Randi Today's Inititive with Randi Today's Inititive with Randi Today's Inititive with Randi Today's Inititive with Randi Today's Inititive with Randi Today's Inititive with Randi Today's Inititive with Randi Today's Inititive with Ran | Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. RecognitionsNamedScience’s Top Employer in 2021 and 2022 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work–certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in BiopharmaTM List, Small and Medium, and one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in NY, NJ, and CT. OverviewReporting to the Senior Director of Clinical Quality Assurance, the AD/Director of Clinical Quality Assurance serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the clinical development team, and collaborates on other related activities performed by Clinical Operations and Medical Departments The incumbent will provide support and promote collaboration internally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines. Depending on experience, this position can be filled at Director or Associate Director level. This is primarily a San Diego based position. Out of state candidates will be asked to make trips to the office as business needs warrant. This is a non-supervisory position (possible future supervisory role, 1-2 people) ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be limited to, the following:
About You:
Up to 15% flexible self-directed travel, both domestic and/or international Salary RangeInsmed takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $165,000.00 to $231,667.00Compensation & BenefitsWe’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:
ADDITIONAL U.S. BENEFITS:
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Please note that we review every submission, and we will keep all submissions on file for six months. Job InformationJob Category:Quality AssuranceSalary:$165,000.00 - $231,667.00 | |
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-66ca8e6dc50805dd6981549ace644d6a-ff-logo.png | Trial Sponsor | https://www.bionjtalentnetwork.org/ | Tuesday Feb 7th Initiative 02 Test | Tuesday Feb 7th Initiative 02 TestTuesday Feb 7th Initiative 02 TestTuesday Feb 7th Initiative 02 TestTuesday Feb 7th Initiative 02 TestTuesday Feb 7th Initiative 02 TestTuesday Feb 7th Initiative 02 Test | Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. RecognitionsNamedScience’s Top Employer in 2021 and 2022 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work–certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in BiopharmaTM List, Small and Medium, and one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in NY, NJ, and CT. OverviewThis position is primarily responsible for providing strategic oversight to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (e.g. SDLC, IT Change Control) per associated regulatory and security requirements. Position will oversee and provide QA support for optimizing, troubleshooting, and maintaining key global GMP quality systems including Veeva Quality Docs (electronic document management system), Veeva QMS (electronic Quality Management System), and additional GxP systems for Gene Therapy manufacturing, quality control, warehouse, and clinical programs. The position will serve as the QA lead for Computer Software Validation lifecycle documents, site IT Change Control facilitation and QA review of CSV documents. ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be limited to, the following: • Manage, maintain, and continuously improve Insmed’s global Electronic Document Management System (EDMS), Quality Management System (QMS), additional Quality owned software platforms (labeling, metrics, etc.) and electronic GxP record archiving.• Serve as QA electronic system validation expert.Provide oversight and QA support on all GxP software used by the Gene Therapy business in accordance with applicable regulations, guidelines, policies and procedures. Types of systems may include: CTMS, LIMS, CMMS, ICN, ERP (inventory management), laboratory equipment software, building management, environmental monitoring, etc.• Train, support and advise end users on EDMS and QMS system requirements and workflows. Develop training modules for EDMS and QMS.• Liaising with corporate QA, eead EDMS and QMS cross functional subject matter expert forum for continuous improvement.• Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents. • Responsible for the local processes related to QMS, IT Change Control, Computerized System Validation, Data Integrity for electronic systems, and monitoring/auditing of audit trails.• Provide support during regulatory inspections and internal audits.• Experience with Veeva systems is preferred.• Experience implementing, validating, maintaining, and integrating electronic document and Quality Management in an FDA or equivalent regulated settings.• Role-related knowledge: Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools.• Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development, including delivery of multiple projects of various complexities• Partner with colleagues in other departments to increase the overall effectiveness of the Quality department• Additional duties as may be assigned from time to time Qualifications• Education – BS Degree required or preferred• A minimum of 5 years of relevant Quality Assurance experience required. An advanced degree (MS) and a minimum of 3 years relevant experience will also be considered• Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc..• Preferred experience in Data Integrity, 21 CFR Part 11, GAMP, CDLC (Agile or Waterfall)• Must have excellent communication skills (verbal and written).• Demonstrate ability to manage projects and variable workloads.• Highly organized with a strong attention to details, clarity, accuracy, and conciseness. • Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies Travel RequirementsUp to 10% travel. Salary RangeInsmed takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $135,000.00 to $188,333.00Compensation & BenefitsWe’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:
ADDITIONAL U.S. BENEFITS:
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Please note that we review every submission, and we will keep all submissions on file for six months. | |
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-66ca8e6dc50805dd6981549ace644d6a-ff-logo.png | Screening Processes | https://www.bionjtalentnetwork.org/ | Tuesday Feb 7th Initiative Test | Tuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTu | ||
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-f035b40522902bcd12e6bd26ccc8ef46-ff-Screen-Shot-2023-02-06-at-12.31.26-PM.png | Workforce Development | https://www.bionjtalentnetwork.org/ | Initiative 07 - Lorem ipsum dolor sit amet, consectetur adipiscing | Consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. | ||
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-f035b40522902bcd12e6bd26ccc8ef46-ff-Screen-Shot-2023-02-06-at-12.31.26-PM.png | Trial Sponsor | http://www.test6.com | https://www.bionjtalentnetwork.org/ | Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Quis ipsum suspendisse ultrices gravida. Risus commodo viverra maecenas accumsan lacus vel facilisis. Lorem ipsu | ||
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-27a4b7d8b09c733f6acf3f0987fd83d0-ff-Screen-Shot-2023-02-01-at-5.16.06-PM.jpg | Site Selection & Expansion | http://www.uniquepagedesigns.com | Initiative 05 - Lorem ipsum dolor sit amet, consectetur adipiscing | Risus commodo viverra maecenas accumsan lacus vel facilisis. | ||
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-27a4b7d8b09c733f6acf3f0987fd83d0-ff-Screen-Shot-2023-02-01-at-5.16.06-PM.jpg | Screening Processes | http://www.uniquepagedesigns.com | Initiative 04 - Lorem ipsum dolor sit amet, consectetur adipiscing | Consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. | ||
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-f035b40522902bcd12e6bd26ccc8ef46-ff-Screen-Shot-2023-02-06-at-12.31.26-PM.png | Policy | https://www.bionjtalentnetwork.org/ | Initiative 03 - Lorem ipsum dolor sit amet, consectetur adipiscing | Dolore magna aliqua. Quis ipsum suspendisse ultrices gravida. Risus commodo viverra maecenas accumsan lacus vel facilisis. | ||
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-f035b40522902bcd12e6bd26ccc8ef46-ff-Screen-Shot-2023-02-06-at-12.31.26-PM.png | Patient Recruitment, Engagement & Community Outreach | https://www.bionjtalentnetwork.org/ | Initiative 02 - Lorem ipsum dolor sit amet, consectetur adipiscing | Risus commodo viverra maecenas accumsan lacus vel facilisis. | ||
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-f035b40522902bcd12e6bd26ccc8ef46-ff-Screen-Shot-2023-02-06-at-12.31.26-PM.png | Data Types | https://www.bionjtalentnetwork.org/ | Initiative - Lorem ipsum dolor sit amet, consectetur adipiscing | Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Quis ipsum suspendisse ultrices gravida. Risus commodo viverra maecenas accumsan lacus vel facilisis. Lorem ipsu |