Pharmaceutical compliance jobs in Bayonne, New Jersey - Page 3Crear alertas

Location: New York City (Must be willing to commute to our brand new state-of-the art Phase 1-4 research center in the Hub in South Bronx near public transporation) Company: Equity Medical, LLC Key Points: Competitive Salary, Rapidly Growing Company. Must be willing to commute to our state-of-the art Ph1-4 research center in the Hub in South Bronx. Candidate also must previous experience as a Clinical Research Coordinator in interventional pharmaceutical sponsored studies (NOT investigator-initiated academic research). Ideal candidate is willing to work in a fast-moving, dynamic, fun, patient-centered environment and is a self-starter and lifelong learner. Job Description: We are seeking a dedicated, experienced, and detail-oriented Clinical Research Coordinator to join our team. The ideal candidate will be responsible for coordinating and overseeing clinical research studies, ensuring compliance with protocols, regulations, and ethical standards. The Clinical Research Coordinator will work closely with investigators, sponsors, and study participants to facilitate the successful execution of research projects. Key Responsibilities: • Coordinate and manage all aspects of clinical research studies, • Assist with recruitment and screening of potential study participants, • Obtain informed consent from participants, • Collect and maintain accurate study data, • Monitor study progress and ensure adherence to protocols, • Communicate effectively with study team members and stakeholders, • Assist with regulatory submissions and compliance activities, • Maintain study documentation and records Qualifications: • Requires a bachelor's degree or equivalent in education and experience, • Previous experience in clinical research coordination for interventional pharmaceutical company sponsored clinical trials, • Excellent verbal and written communication skills, • Computer skills required, • Intimate knowledge of Good Clinical Practice (GCP) guidelines, • Strong organizational and communication skills, • Ability to work independently and as part of a team, • Attention to detail and ability to multitask Other Requirements: Contact with patients and/or human research subjects Potential bloodborne pathogen exposure Successful completion of applicable compliance and systems training requirements If you are passionate about clinical research and are looking for an opportunity to contribute to cutting-edge medical advancements, we encourage you to apply for the Clinical Research Coordinator position. Please send an email to with your CV. About Equity Medical Equity Medical, LLC (“EM") is a multi-state, multi-therapeutic area, Ph1-4 clinical trial research company with an independent CRO division. EM is committed to excellence in diversity and the creation of an inclusive learning and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.

Principal Consultant – Project Manager, Life Sciences, Infosys Consulting The Role – What You’ll Do You will be part of a dynamic, cross-functional global team delivering strategic consulting engagements for leading Life Sciences organizations. We are seeking Project Managers at Principal Consultant level to support large scale IT and business transformation programs within the Life Sciences domain. The role requires professionals with a solid understanding of IT project management processes, strong communication skills and the ability to engage directly with clients. Selected candidates will be trained further on domain specific requirements You will manage project delivery, stakeholder engagement, and cross-team collaboration while applying industry best practices and agile methodologies. You will be responsible for ensuring successful outcomes across digital transformation, operational excellence, and regulatory compliance initiatives. Here are some engagements our Life Sciences consultants are working on: • Leading digital transformation programs for global pharmaceutical firms to modernize clinical trial operations and improve patient engagement., • Implementing regulatory information management systems to streamline compliance and submission processes., • Driving commercial analytics initiatives to optimize product launch strategies and market access., • Managing enterprise-wide data governance programs to ensure data integrity across R&D and regulatory functions., • Coordinating cross-border teams to deploy AI/ML solutions for drug discovery and pharmacovigilance., • Supporting change management and training programs for global rollouts of life sciences platforms (e.g., Veeva, Medidata, Oracle Health Sciences). Responsibilities • Lead end-to-end IT project lifecycle (initiation, planning, execution, monitoring, closure), • Establish and drive program governance, status reporting, risk/ issue tracking, and stakeholder communication, • Directly engage with client leadership and represent the program in governance forums., • Facilitate workshops, status meetings, and steering committee updates with senior stakeholders., • Manage project documentation, dashboards, and reporting (excel/ PowerPoint), • Identify risks and mitigation strategies, ensuring compliance with industry regulations (e.g., GxP, FDA, EMA)., • Mentor junior consultants and ensure delivery quality across distributed teams, • Support business development efforts including proposal creation, client presentations, and solution design., • Contribute to internal initiatives such as knowledge management, capability building, and thought leadership. Basic Qualifications • Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred., • 7+ years of experience in project management within the life sciences industry or consulting., • Experience to lead IT projects as project manager in multiple delivery methodologies (e.g. waterfall, agile)., • Location: Dallas, NY, NJ, • Hands-on experience with project management tools (MS project or equivalent), • Strong excel and PowerPoint skills for reporting and presentations, • Proven track record of delivering complex programs in pharmaceutical, biotech, or medical device sectors., • Excellent communication, presentation, interpersonal skills, stakeholder management, and problem-solving skills., • PMP, or Agile certification is a plus., • Candidates authorized to work for any employer in the United States without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time Preferred Qualifications / Skills • Familiarity with clinical trial operations, regulatory submissions, pharmacovigilance, or commercial analytics., • Ability to work across global teams and manage stakeholders in multiple time zones., • Strong analytical mindset with experience in data-driven decision-making. Benefits Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits: • Medical/Dental/Vision/Life Insurance, • Long-term/Short-term Disability, • Health and Dependent Care Reimbursement Accounts, • Insurance (Accident, Critical Illness , Hospital Indemnity, Legal), • 401(k) plan and contributions dependent on salary level Infosys Consulting is the global management and technology consulting practice of Infosys, a global leader in technology services and consulting. We combine the power of time-tested methodologies, people-driven innovation and disruptive technology to enable leaders of the world’s top brands pursue a path of smart transformation. Together with our clients, internal and external partners, we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants: • Ability to design and implement end-to-end solutions at scale, • A flat organization structure with direct access to our senior-most leaders, • An entrepreneurial environment full of bright, highly motivated consultants, • Opportunities for motivated consultants to impact local communities, • The ability to design your career and drive your professional learning and development, • A truly global culture EEO Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.

Principal Consultant, Business Consulting – Computer System Validation- Life Sciences We are looking for smart, self-driven, high-energy people with intellectual curiosity and passion for excellence; specifically, we are looking for candidates at Principal Consultants levels who are experienced in IT Computerized System Validation (CSV) within Life Sciences domain. Responsibilities: • Create, review, and approve validation deliverables, • Define IT system development processes (build, test, deploy, monitor) following Agile ways of working and ensure followed compliance in each release /Iteration, • Working experience on Agile/JIRA, Confluence, ALM, • Author major project validation deliverables as per client’s standard operating procedures, • Review and approve system lifecycle deliverables generated by project team, • Guide project teams on applicable validation, security, and project management deliverables, • Advise project team on implementation of compliance and security control requirements at the appropriate stages of system development, • Contribute to internal and external audits, assessments, or inspections, • Escalate critical compliance findings, risks, or issues into appropriate client units, • Prepare management reports regarding compliance operations and progress Basic Skills & Experience • 7 plus years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry., • Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5., • Experience creating, reviewing and approving validation deliverables., • Knowledge of risk management processes., • Thorough knowledge in compliance and validation concepts., • Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments., • Preferable IT background to understand complexities on the program., • Collaborative attitude., • Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time Required Skills & Experience • Strong understanding of pharmaceutical compliance regulations and validation concepts., • Experience with Agile and Waterfall methodologies., • Familiarity with tools like ServiceNow, JIRA, Veeva, HPALM., • Ability to manage multiple projects and adapt to complex environments., • IT background preferred to understand program complexities., • Excellent communication and collaboration skills. EEO/About Us : Benefits Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits: • Medical/Dental/Vision/Life Insurance, • Long-term/Short-term Disability, • Health and Dependent Care Reimbursement Accounts, • Insurance (Accident, Critical Illness , Hospital Indemnity, Legal), • 401(k) plan and contributions dependent on salary level Infosys Consulting is the global management and technology consulting practice of Infosys, a global leader in technology services and consulting. We combine the power of time-tested methodologies, people-driven innovation and disruptive technology to enable leaders of the world’s top brands pursue a path of smart transformation. Together with our clients, internal and external partners, we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants: • Ability to design and implement end-to-end solutions at scale, • A flat organization structure with direct access to our senior-most leaders, • An entrepreneurial environment full of bright, highly motivated consultants, • Opportunities for motivated consultants to impact local communities, • The ability to design your career and drive your professional learning and development, • A truly global culture EEO Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.

As part of the Regulatory Risk and Compliance Generalist team you deliver exceptional healthcare compliance consulting services to clients in the pharmaceutical and medical device industries. Responsibilities - Deliver healthcare compliance consulting services to pharmaceutical and medical device cl

Regulatory Compliance Oversight. Ensure compliance with serialization, track?and?trace, and DSCSA requirements. Advise leadership on regulatory trends, enforcement priorities, and compliance risks.