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job summary: You are a part of Clinical Affairs orgabization. The Clinical Development Scientist reports to the Director of Clinical Affairs in the business.   location: Cambridge, Massachusetts job type: Contract salary: $80 - 95 per hour work hours: 8am to 5pm education: Masters   responsibilities: You are responsible for: - Leading the development of evidence generation strategies for assigned projects, working within a cross-functional team, in line with the value proposition that addresses the evidence needs of all key stakeholders - Delivery of Clinical Development Plans, describing the plans for clinical evaluation, as per internal and external requirements (US,EU, China, etc) - Working closely together with internal (project owners, regulatory, clinical study managers, statisticians, business leaders, etc.) and external (clinical consultants such as key opinion leaders and subject matter experts) stakeholders to ensure that studies yield well-founded conclusions. - Design and development of study protocols in compliance with project standards, specifications and applicable regulatory guidelines (GCP, ICH, FDA, ISO, EU MDR). Manage and oversee study execution, analysis of results and generation of final study reports to support Philips regulatory clearances, claims, epidemiology/surveillance, reimbursement, health economic outcomes and/or market access. - Deliver assigned clinical programs, working in partnership with Clinical Operations. - Lead the development and dissemination of evidence generated from clinical evaluation plans to deliver Clinical Evaluation Reports in accordance with EU and China requirements, Clinical Study Reports and Clinical Summaries, and manuscripts - Lead clinical evidence, epidemiology/surveillance discussions with regulators (deficiency requests/FDA, Notified Bodies, etc.), advisory boards, associations, and societies - Keeping current with regulatory guidance and requirements in the global environment. - Ensuring appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, etc. - Support Medical Safety function to help support signal detection, signal evaluation - Advance the Philips Data network strategy by developing innovative data partnerships - Support the creation of data infrastructure efficiency through creation of systematic processes including data dictionaries, including the evaluation of real-world data vendors, and data access and transfer models. - Support the Data Governance Council in leading understanding of deidentification and data use standards (including, data tokenization)   qualifications: Experience level: DirectorMinimum 7 years of experienceEducation: Masters  skills: Clinical Development Plans (5 years of experience is required)MD, PhD/MS Degreeclinical research/development (7 years of experience is required)Communication Machine Learning Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). This posting is open for thirty (30) days.

Embrace a thrilling opportunity to work with a leading biotechnology company that is revolutionizing healthcare through groundbreaking mRNA technology. Join a dynamic team of scientists and researchers dedicated to developing life-changing vaccines and therapeutics. At this innovative organization, you'll have the chance to contribute to cutting-edge discoveries and make a meaningful impact on global health. Grow your career in a supportive and collaborative environment, surrounded by passionate individuals driven to make a difference in the world.  salary: $29 - $31 per hourshift: Firstwork hours: 8 AM - 8 PMeducation: High SchoolResponsibilitiesHere’s what you’ll be doing:This role will be part of a cohesive team responsible for producing GMP mRNA-based medicines for evaluation in human clinical trials. He/she will support the handling and processing of materials within manufacturing operations facility in accordance with established processes and procedures. Safely transport product, equipment, and materials adhering to SOPs and EH&S requirements for mRNA medicine manufacturing.Assist in various manufacturing, QA, and logistics activities while strictly adhering to GMPs and documentation protocols.Maintain a clean operating area, adhere to gowning procedures, and ensure compliance with waste handling procedures and environmental regulations. Here’s what you’ll have: High school diploma or GED requiredExperience in a highly-regulated industry, Pharmaceutical, or related field Here’s what you’ll get: Above market pay at $30.00 per hourExcellent BenefitsFriendly coworkers and team membersSupportive management invested in your success Skills Material Handling (1 year of experience is required) Qualifications Years of experience: 1 yearExperience level: Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.

Embrace a thrilling opportunity to work with a leading biotechnology company that is revolutionizing healthcare through groundbreaking mRNA technology. Join a dynamic team of scientists and researchers dedicated to developing life-changing vaccines and therapeutics. At this innovative organization, you'll have the chance to contribute to cutting-edge discoveries and make a meaningful impact on global health. Grow your career in a supportive and collaborative environment, surrounded by passionate individuals driven to make a difference in the world.  salary: $29 - $31 per hourshift: Firstwork hours: 8 AM - 8 PMeducation: High SchoolResponsibilitiesHere’s what you’ll be doing:This role will be part of a cohesive team responsible for producing GMP mRNA-based medicines for evaluation in human clinical trials. He/she will support the handling and processing of materials within manufacturing operations facility in accordance with established processes and procedures. Safely transport product, equipment, and materials adhering to SOPs and EH&S requirements for mRNA medicine manufacturing.Assist in various manufacturing, QA, and logistics activities while strictly adhering to GMPs and documentation protocols.Maintain a clean operating area, adhere to gowning procedures, and ensure compliance with waste handling procedures and environmental regulations. Here’s what you’ll have: High school diploma or GED requiredExperience in a highly-regulated industry, Pharmaceutical, or related field Here’s what you’ll get: Above market pay at $30.00 per hourExcellent BenefitsFriendly coworkers and team membersSupportive management invested in your success Skills Material Handling (1 year of experience is required) Qualifications Years of experience: 1 yearExperience level: Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.