post-market surveillance specialist.

job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Cambridge, Massachusetts job type: Contract salary: $83.42 - 98.14 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Under the direction of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing a Core Dossier for Module 3 and preparing Module 3 documents to support Marketing Authorization Applications in Japan and Brazil. Provide support to other HA interactions as required. Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into submissions for marketing authorizations.Provide Reg CMC support for development programs to ensure that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned.Manage preparation of Core Dossier, Japan and Brazil applications in a timely manner to meet corporate objectives. Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives. 30%: Develop global CMC Core Dossier for Module 3 20%: Prepare Module 3 Marketing Authorization Application for Japan 30%: Prepare Module 3 Marketing Authorization Application for Brazil. 10%: Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines. 10%: Provide CMC regulatory guidance to project / product teams.   qualifications: B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field. Minimum of 4 years experience in pharmaceutical product development including significant experience in CMC regulatory affairs with a strong biologics background or equivalent.Experience in directing interactions with regulatory authorities desired.Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance. Significant coordination with cross-functional teams internally and regulatory authorities externally.   skills: CMC, FDA, GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Submissions, ICH Regulations 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. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: Amazing client is looking to hire a season Event Specialist - role is 100% remote right now. Ideally the candidate would be based out of one of the following markets: Dallas/Ft Worth market, Memphis, Phoenix, Boston, Austin, or Pittsburgh as the offices are beginning to open up and down the road it might move to a hybrid role. Candidates MUST be a CMP ( certified meeting planner) and have substantial experience using Cvent. Apply Today!   location: Andover, Massachusetts job type: Contract salary: $30 - 38 per hour work hours: 8am to 4pm education: Associates   responsibilities: This role will be responsible for providing a world-class level of customer service on a day-to-day basis that represents the company in customer facing events. This position will manage key programs within Medical Education from inception to completion and will act as a true business partner with Sales, Marketing and integral internal functions to ensure delivery of the highest quality. Additionally, the Medical Education Event Operations Specialist will be responsible for logistical ownership of entire event cycle including venue sourcing, contract negotiation, AV/production sourcing, ground transportation, F&B planning, event design, web design, mobile app & registrations, onsite event support as well as program budget management and reconciliation. This person will be able to utilize event technology logistics with Cvent Software, including registration, attendee tracking, reporting, onsite registration, mobile app creation, marketing initiatives, and pre/post-event evaluations. This person will have excellent time management, communication skills both written and verbal, and the ability to manage multiple tasks while maintaining a high level of customer service. Event Management Planning - Manage all aspects of event planning for Medical Education courses and initiatives - Ensure corporate spend is within Health Care Compliance (HCC) guidelines - Research resources, make site visits, and lead pre-event meetings when necessary to help staff make decisions about event design Event Management Execution - Lead on-site specialist for large scale Medical Education events, including management of registration desk and printed collateral. - Reconcile and submit payments for Corporate meeting Card and routinely monitor charges to ensure proper usage - Plan and facilitate logistics for all events, including contract negotiations, guest lists, venue preparation, presentation materials, security, catering, entertainment, transportation, equipment, decor, and marketing materials - Troubleshoot and handle any issues that arise on the event day - Conduct Venue sourcing and negotiations via Cvent Supplier Network - Utilize technology such Zoom, Cvent, OnArrival, Social Tables, Crowd Compass and others as necessary - Generate and download reports: registrant, attendee, polling responses, and Q&A - Sends out confirmation email through Cvent - Tracks and processes all changes, including updating hotel confirmation numbers and cancellation numbers, room name changes - Provides reports such as: rooming, participants list, ground transportation, group air, arrival and departure, food and beverage, translation etc . - Knowledge of meeting planning policies, procedures, compliance and business practices Reporting and Compliance - Maintain accurate Open Payment reporting for the US and OUS required reporting at the country or regional level as needed - Track HCP expenses and event budgets in CVENT event registration system as appropriate Ad hoc duties Stay current, and often ahead of the curve, on event planning, design, and production trends, proactively identifying and solving operational challenges. REQUIREMENTS Travel +/- 20% domestic travel Education Bachelor's degree or equivalent experience. Experience 7-10 years' experience in meeting planning and coordination, preferably in the medical industry. - CMP Preferred Competencies - CMP (certified meeting planner) an absolute MUST - Proven success as an event planner or coordinator, must have Cvent software experience - Flexible "can do" attitude, adaptable to change - Excellent written and verbal communication skills - Highly detail oriented with a critical degree of accuracy regarding event details - strong interpersonal and communication skills - Highly organized, detail conscious, and able to prioritize multiple tasks - High level competency in planning and organization - Microsoft office proficiency - Prepared to work flexible hours - Cvent Certification strongly preferred   qualifications: Experience level: ExperiencedMinimum 3 years of experienceEducation: Associates  skills: Event ManagementCVentCMP Event Planner 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. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: This client's Market Data Operations team is responsible for the provisioning, obtaining of authorization, source reporting and data usage compliance of market data both internally and externally. The Market Data Operations Manager will play a critical role in the management and oversight of the day-to-day activity of the Market Data Operations team of junior level and senior level analysts. This includes the general management of key team functions including, but not limited to, Market Data Source Policy Management and Reporting. The ideal candidate will have experience in Direct Team Management; General Market Data Policies; Analyzing, Interpreting and Processing Data; and Data Reporting. This manager will also be expected to come in with a strategic focus to also work alongside the director and team to further improve data management processes and identify opportunities/initiatives for automation within data collection. This manager will also be responsible for coaching the team on how to provide a proactive, forward-facing, service oriented group with a clear understanding of the value of the corporate strategic assets ("the data") of which they are in effect the custodians. They will help implement a series of clearly defined best practices across all business lines and all product lines to support the global business in a timely, efficient & compliant way. They will also maintain implementation of the company's robust processes to support the sales cycle and the client on-boarding process while adhering to their core principles of source compliance & consistency. Requirements: 7+ years of relevant work experience and 2-3+ years of people management experienceGeneral understanding of 3rd party and exchange rulesExtensive Microsoft Office skills and Excel and PowerPoint are essential. Visio knowledge is preferred. Excel proficiencies include Pivot Tables/Charts, VLOOKUP, INDEXMATCH, VBA Macro Thoroughness, attention to detail and the ability to think and work both independently and within a team environmentService oriented toward both internal and external clientsGreat organizational, prioritization and time management skillsProject Management experience a plusData Analytics experience a plus (exposure to SQL, Tableau and Python are nice to haves)Good written, oral, interpersonal, and presentation skills with the ability to interact with all levels within an organizationCollege or University degree required   location: Bedford, Massachusetts job type: Permanent salary: $105,000 - 130,000 per year work hours: 9am to 5pm education: Bachelors   responsibilities: Manage team's day-to-day activityBuild and implement procedures for new product rolloutsOversee and execute projects/procedures to drive increased operational efficiency in both new and existing workflowsManage the preparation and distribution of comprehensive usage reporting of ICE Data Services client base to various third-party vendors on a recurring basisEnsure said reporting is compliant with contractual obligationsValidate invoices and payment requests from sources against usage reporting and other contractual obligations (e.g., internal license and connectivity fees.)Liaise with vendors and internal stakeholders to resolve issues regarding usage reporting or billingMonitor changes in source policies and their impact to the client base, as well as internal workflows and proceduresPrepare and maintain consistent usage and expense analytics based on various usage and invoice reports. E.g.: Variance Reports and Trend AnalysesLead, support, and/or participate in multiple MDO specific, and cross-departmental projects   qualifications: Experience level: ManagerMinimum 7 years of experienceEducation: Bachelors (required)  skills: Data AnalysisExcelSQLTableau 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. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.