Medical Writer - I Integrated Resources, IncMedical Writer - IRaynham, MassachusettsContractormedical writing, regulatory affairs, clinical research, engineering)BS/B.Pharm/BSN or MS or MPH plus 4 to 5 years of relevant medical device/drug industry experienceKnowledge/RequirementsExcellent English language skills, especially writing and proofreading. Job DescriptionOverview:The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the Client Strategic Medical Affairs Team for a wide range of audiences.
Associate Director, Medical Writing Rhythm PharmaceuticalsAssociate Director, Medical WritingBoston, MA$160,000–$240,000 / yearDrive document execution for complex global programs by defining development steps, timelines, resources, review processes, data needs, and cross-functional communications to deliver key documents on time, including protocols, clinical study reports, investigator brochures, regulatory submissions, and response documents. Ensure accuracy and consistency across clinical, medical, regulatory, and pharmacovigilance documents by providing expert review of study- and program-level materials, including regulatory submissions, annual reports and updates, DSURs, PBRERs, posters, and manuscripts.
NewPhysician Assistant Surgical Oncology Mass General BrighamPhysician Assistant Surgical OncologyBoston, MassachusettsMass General Brigham offers a comprehensive benefits package to eligible employees, including medical, dental, and vision insurance; generous paid time off; tuition reimbursement; retirement plan options; commuter benefits; access to childcare resources and emergency backup care; and employee perks and discounts. Advanced Practice Providers at the Mass General Brigham Cancer Institute also benefit from structured onboarding, mentorship, professional development opportunities, and a collaborative environment that supports growth across clinical, academic, and leadership pathways.
Director, Psychometrics & Patient-Reported Outcomes (PRO) Strategy Ipsen SADirector, Psychometrics & Patient-Reported Outcomes (PRO) StrategyCambridge, MA$177,000–$259,600 / yearPartner effectively across the enterprise to support the identified psychometric needs across Oncology, Rare Disease and Neuroscience and play a central role in designing PRO strategies that address key evidence needs and gaps; Oversee and drive methodologic strategy for patient-reported/patient-centered outcome study strategies & designs, including studies where patient-reported outcome (PRO) instruments are to be developed and/or validated and/or evaluations need to be conducted around mapping of clinically meaningful changes in patient-reported outcome measurements; Collaborate with cross-functional teams to ensure well designed patient-centered outcome endpoints are included in clinical development studies and patient-centric endpoints are available for HTA and regulatory submissions; Partner with Clinical Development teams to provide support for study design and planning activities; Support, as relevant, design of fit-for-purpose data generation and analytic methodologies that advance research goals across different LCM stages; Develop and review study protocols and statistical analyses plans in collaboration with Biometrics, Medical and other internal stakeholders; Stay informed and involved on the latest HTA and Regulatory and methodological advances that expand and enhance the utility of PROs. Fully involve Ipsen stakeholders (GMA TAs, R&D, HEOR, Regulatory, Clin Ops, GMPC, and affiliates) in the design and implementation of studies around PROs, from design to communication; Ensure Ipsen can provide comprehensive patient focused data & analytics in the disease areas we serve; Drive cross-functional and global dialogue to enable early strategic alignment of PRO data across global and local teams, in partnership with the cross-functional partners across product life cycles, to ensure company is working with single source of information; Establish end-to-end best practice for information sharing regarding PROs used across assets; Conduct educational sessions around key topics of interest and relevance to internal stakeholders, with a goal to build educational modules.
Administrative Nursing Supervisor Lahey Hospital and Medical CenterAdministrative Nursing SupervisorBurlington, MA$125,985.60–$187,200 / yearIn collaboration with the ACN of the specific clinical area and Nurse Manager, The Administrative Supervisor supervises all nursing staff in clinical patient care areas to ensure quality patient care. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law.
Decision Analytics Associate Consultant - HEOR Value and Evidence Communication ZS Associates IncDecision Analytics Associate Consultant - HEOR Value and Evidence CommunicationBoston, MAAs a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. We work with our clients to go beyond delivering high quality studies, to helping them make sure the work they are undertaking are the right ones to support their strategic priorities, and even shape those priorities.
Site Relationship Manager Integrated Resources, IncSite Relationship ManagerCambridge, MassachusettsContractorStrong communication and leadership skills· Strong preference for candidate local to the Clients Cambridge office to work on campus routinely· Strong preference for experience with late phase and observational clinical research CNS and MS experience preferred EDUCATION:· Minimum of a Bachelor of Science degree in a health related field with clinical research experience Assures ongoing site compliance with the protocols, informed consent process and documentation, as well as applicable FDA regulations and/or ICH GCP Guidelines and other local regulations critically reviews and analyses site activities and study conduct through on-site and remote assessments/contacts.· Ensures timely submission of high quality of data from study sites and appropriate query resolution.·
NewClinical Research Systems Specialist Iterative Scopes IncClinical Research Systems SpecialistCambridge, MA$25–$40 / hourA Clinical Research Systems Specialist at Iterative Health plays an important role in enabling our clinical research operations by ensuring the systems, study builds, and operational materials that support our trials are accurate, efficient, and ready for use by our teams and research sites. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
Senior Accountant - Biotech JobotSenior Accountant - BiotechBoston, MA$80,000–$110,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. Backed by strong investors and a collaborative leadership team, we're entering an exciting phase of growth and are expanding our finance organization to support our continued success.
Venous Access RN South Shore HealthVenous Access RNWeymouth, MAParticipates as a member of a multidisciplinary care team that requires effective communication and collaboration with co-workers and staff at the Institute, BWH, and other collaborating institutions and agencies. Educates patient and family regarding various aspects and treatment modalities of disease, including vein choice, vein preservation techniques, and line care if applicable.
Clinical Social Worker (LICSW) - Lurie Center for Autism Brigham and Women's HospitalClinical Social Worker (LICSW) - Lurie Center for AutismLexington, MA$70,990.40–$103,230.40 / yearThe Clinical Social Worker performs compressive assessments and collaborates with healthcare team members to develop and implement patient centered treatment plans that integrate the medical, social, and resource issues that impact individual patients and families. The Clinical Social Worker is an essential member of multidisciplinary care team at the Lurie Center for Autism, a clinical, research, training and advocacy program dedicated to treating individuals with autism spectrum disorder and other developmental disorders across the lifespan.
Manager, Clinical Study Lead Regeneron PharmaceuticalsManager, Clinical Study LeadUxbridge, MAAssigns tasks to Clinical Study Management staff and supports their deliverables; directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight); recommends and participates in cross-functional and departmental process improvements; and identifies innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs. Discover your role: Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees execution against planned timelines, deliverables, and budget while raising issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective action.
Associate Director (Trial Master File) Integrated Resources, IncAssociate Director (Trial Master File)Cambridge, MassachusettsContractorPosition: Associate Director (Trial Master File Operations and Systems Management)Location: Cambridge MADuration: 6+ MonthsResponsibilities:• Manage overall TMF operations and third party vendors, and act as a single-point-of-contact for all vendor inquiries and for all TMF vendor management activities. Associate Director (Trial Master File)A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Director, Clinical Operations Program Leadership (Copl) Biogen IdecDirector, Clinical Operations Program Leadership (Copl)Cambridge, MA$209,000–$288,000 / yearThe Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Contract Clinical Trial Associate StratAcuity Staffing Partners IncContract Clinical Trial AssociateWaltham, MA$47–$52 / hourIn terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
Associate National Clinical Launch & Product Specialist - East Stryker CorpAssociate National Clinical Launch & Product Specialist - EastBoston, MA$77,700–$129,500 / yearIn this field-based position, you will collaborate closely with healthcare professionals, hospital staff and cross-functional teams to implement clinical launch plans, deliver education and training, provide procedural support, and help integrate robotic-assisted technology into surgical workflows. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
Global Clinical Quality (GCQ) Associate Director Vertex Pharmaceuticals IncGlobal Clinical Quality (GCQ) Associate DirectorBoston, MA$160,600–$240,800 / yearThese activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, monitoring and trending of quality risks, issues and compliance metrics, investigation and CAPA management and proactive inspection readiness activities. Key Duties and Responsibilities: Serve as a key technical resource for the GCP clinical execution function with responsibility of assuring quality risk management/ mitigation and adequacy and compliance with GCP regulatory requirements and guidance to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated.
NewDirector, Patient Randomization Rate Iterative Scopes IncDirector, Patient Randomization RateCambridge, MA$160,000–$215,000 / yearYou'll use data to identify where patient volume, conversion, or operational processes are limiting performance, then design and test scalable solutions-from referral programs and community outreach to workflow improvements and external partnerships. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
Principal Scientist II - Pharmacology Novartis AGPrincipal Scientist II - PharmacologyCambridge, MA$126,000–$234,000 / yearResponsibilities:Design pre-clinical in vivo studies to explore novel hypotheses, screen candidate molecules, and establish proof-of-concept of new modalitiesDevelop in vivo CDX, PDX, and syngeneic models to evaluate anti-tumor activity, PK/PD relationships, relevant biomarkers, and key translational questionsManage associate-level scientistsCollaborate with cross-functional project teamsCritically analyze and present results within a multidisciplinary team environmentCareful adherence to animal protocols and proper documentation of data and methods in electronic laboratory notebookQualifications:PhD with 5-8 years of research experience as a postdoc or in the pharmaceutical/biotech industryDeep knowledge of antibody drug conjugatesExtensive experience working with CDX and PDX xenograft tumor models and/or syngeneic modelsExpertise in cell culture, PCR, ELISA, western blot, and flow cytometryStrong analytical, communication (written and verbal), and organizational skills, including a proficiency with PowerPoint and commonly used data analysis programs, such as Prism and ExcelNovartis Compensation and Benefit Summary: The salary for this position is expected to range between $126,000 and $234,000 per year. The successful candidate will join a dynamic, multi-disciplinary team and play a key role in the development and application of in vivo models for evaluating novel cancer therapies and advancing the early-stage drug discovery pipeline.
Modeling & Simulations Associate Director Vertex Pharmaceuticals, IncModeling & Simulations Associate DirectorBoston, MA$168,000–$252,000 / yearGeneral Summary: The Modeling & Simulations Associate Director will be responsible for developing and executing M&S strategies and activities in cross functional drug development project teams in close collaboration with colleagues in Clinical Pharmacology, Biostatistics, Research and other colleagues within the R&D. Typically requires the following: PhD and 6 years experience or Master's Degree and 10 years experience in the application of Pharmacometric and other Modeling methodologies in the context of drug research & development in industry, academia or regulatory agencies.