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Job DescriptionAbout MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit or follow MMS on LinkedIn. Responsibilities • Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias, • Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals, • Complete writing assignments in a timely manner, • Maintain timelines and workflow of writing assignments, • Practice good internal and external customer service, • Highly proficient with styles of writing for various regulatory documents, • Expert proficiency with client templates & style guides, • Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects, • Contribute substantially to, or manages, production of interpretive guides, • Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary, • Mentor medical writers and other members of the project team who are involved in the writing processRequirements, • At least 3 years of previous experience in the pharmaceutical industry, • Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience, • The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline, • Substantial clinical study protocol experience, as lead author, required, • Experience leading and managing teams while authoring regulatory documents with aggressive timelines, • Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus, • Understanding of clinical data, • Exceptional writing skills are a must, • Excellent organizational skills and the ability to multi-task are essential prerequisites, • Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools, • Experience being a project lead, or managing a project team, • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus LtPXymlXil

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: • Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs), • Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity, • Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data, • Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents, • Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports), • Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC, • Demonstrated ability to lead others to complete complex projects, • Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines, • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment, • Organizational expert within the nonclinical subject area, • Excellent written/oral communication and strong time and project management skills, • Ability to attend regular team meetings, lead client meeting and CRMs, • Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars, • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)Requirements:, • BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control, • Knowledge of GLP, ICH guidelines, and applicable regulatory requirements, • 2+ years of pharmaceutical regulatory nonclinical writing experience, • Strong writing and analytical skills, • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred uuQhjdtYkG

Job Description The Manager, TMF Operations role ensures a complete, accurate, and high-quality Trial Master File (TMF) as the subject matter expert through proper, consistent documentation and proactive partnership with clinical study teams. This role involves working directly with all functions, both internal and external, that contribute to the TMF to ensure regulatory inspection readiness for clinical trials. The position also involves assisting in TMF set-up, document collection and filing, monitoring quality, timeliness, and completeness, and following up with study teams to resolve TMF-related issues. Responsibilities • Ensure all TMF-related tasks meet expectations and are delivered in accordance with applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines, and study-specific processes/requirements., • Set up the TMF and Expected Document Lists (EDLs) by collaborating with relevant members of the study team., • Act as the primary contact and point of escalation for TMF issues., • Facilitate the creation, review, and approval of TMF plans and filing structures., • Perform periodic TMF Quality, Timeliness, and Completeness Reviews to maintain an inspection readiness state throughout the clinical trial., • Facilitate the planning and execution of periodic TMF content reviews., • Identify and inform study teams of TMF quality trends, such as rejection reasons and commonly misfiled documents., • Support documentation collection and filing activities, including document scanning and indexing, and perform technical (Quality) QC of uploaded documents., • Initiate Quality Issue workflow when document issues are identified., • Identify and work with functional areas to collect incomplete, missing, and/or expired documents., • Collaborate with functional area teams and vendors to resolve discrepancies and ensure timely completion of internal tasks related to TMF deliverables., • Execute TMF archival activities., • Provide guidance to internal teams on performing functional QC of TMF documents., • Participate in preparation/reconciliation of TMF documentation related to audits, inspections, and shipments., • Support risk mitigation strategies or corrective and preventative actions to document management issues., • Support TMF process development, improvement, and implementation, including the development of procedural documents and/or job aids related to TMF activities., • 6+ years of experience with a Bachelor's degree, • Experience in a pharmaceutical/biotechnology/CRO organization’s TMF/records management function preferred., • Knowledge of the TMF Reference Model, ALCOA+ standard, Good Documentation Practices, or relevant working experience in pharmaceutical/scientific environments., • Experience in supporting audits and regulatory inspections desirable., • General knowledge of clinical trials and basic principles of overall trial planning and execution., • Basic understanding of ICH-GCP guidelines and FDA/EMA/PMDA regulations., • Familiarity with MS Word, MS SharePoint, MS Visio, Adobe Acrobat Professional, MS Excel, and MS PowerPoint., • Ability to handle a high volume of tasks within a given timeline., • Ability to interact with key stakeholders across Clinical Development functional areas. This role requires a minimum of 3 days a week of onsite presence (or more as business needs require) in either the Jersey City, NJ. The work environment supports significant team growth and collaboration. Job Type & Location This is a Permanent position based out of Jersey City, NJ. Pay and Benefits The pay range for this position is $122000.00 - $133000.00/yr. 401k plan with company matching Medical (premiums covered at 95%), dental and vision insurance (premiums covered at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site Workplace Type This is a hybrid position in Jersey City,NJ. Application Deadline This position is anticipated to close on Dec 18, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

The Chief Risk Officer (CRO) is responsible for overseeing Momentus Capital's risk strategy, ensuring business resilience, and aligning risk management with corporate objectives and key performance indicators (KPIs). The CRO reports directly to the President and Chief Executive Officer (CEO) and wil

A company is looking for a Conversion Rate Optimization (CRO) Specialist.Key Responsibilities Perform audits of clients' web analytics implementations and recommend improvements Conduct in-depth competitor and market research to identify conversion strategies Develop and execute conversion rate

Key Responsibilities Manage the collection, cleansing, and maintenance of marketing data across various platforms Translate raw data into insights that inform campaign strategy and performance optimization Support the configuration and optimization of marketing tools while collaborating with cro

Clinical Trial Contract And Budget Manager. We are currently seeking a Clinical Trial Contract and Budget Manager to join our diverse and dynamic team. Support the review and processing of clinical trial country master and site budgets and agreements escalated from the CRO, in alignment with establi

We're seeking a client-focused.Conversion Rate Optimization (CRO) expertise.If you thrive in a fast-paced agency environment and enjoy blending technical know-how with strategic client interaction, this role is for you.A/B testing, and performance tracking.Collaborate with design, marketing, and dev

Job Description Tiger Analytics is a fast-growing advanced analytics consulting firm. Our consultants bring deep expertise in Data Science, Machine Learning and AI. We are the trusted analytics partner for several Fortune 100 companies, enabling them to generate business value from data. Our business value and leadership has been recognized by various market research firms, including Forrester and Gartner. We are looking for top-notch talent as we continue to build the best analytics global consulting team in the world. Requirements • 15+ years of Program Management experience, • Coordinating multiple projects and reconciling the interdependencies among them, • Providing strategic guidance to the company's project managers., • Monitor and adjust daily program activities as needed. Monitor key performance indicators for program and program progress, • Develop best practice, processes, and standards for effectively carrying out data migration activities, conceptual understanding of data engineering and cloud technologies., • Should have been in customer facing roles in managing large engagements, • Resolving cross-program issues and strategic issues with senior stakeholders, • Prepare reports for directors and stakeholders, • Implement strategies, oversee collaboration, and define success metrics, • Ability to Strategize and outline the goals and objectives of the program, find innovative ways to resolve problems Life Science Experience: • Should have good understanding of Pharma / Life Science domain and regulatory requirements Significant career development opportunities exist as the company grows. The position offers a unique opportunity to be part of a small, challenging, and entrepreneurial environment, with a high degree of individual responsibility.