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Global Project Manager Salary in Waltham, MA

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Agile Project Manager

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Applications Manager

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Applications Project Manager

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Architect Project Manager

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Assistant Project Manager

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Associate Project Manager

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Business Project Manager

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Capital Project Manager

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Clinical Project Manager

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Customer Project Manager

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Design Project Manager

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Digital Project Manager

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Electrical Project Manager

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Facilities Project Manager

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Finance Project Manager

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General Project Manager

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Healthcare Project Manager

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Implementation Project Manager

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Infrastructure Project Manager

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International Project Manager

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Marketing Project Manager

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Principal Project Manager

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Program Coordinator

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Project Assistant

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Project Control Manager

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Project Controls Manager

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Project Coordinator

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Project Integrator

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Project Management Consultant

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Project Manager

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Project Officer

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Project Specialist

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Security Project Manager

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Software Project Manager

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Support Project Manager

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Systems Project Manager

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Technical Project Manager

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Technology Project Manager

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Testing Project Manager

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Training Project Manager

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Utilities Project Manager

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Clinical Trial Leader (Cary/Wilmington, NC or Waltham, MA)
Allucent, Waltham
DescriptionAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Trial Leader (CTL) to join our A-team (hybrid*/remote). As a CTL at Allucent, you are responsible for providing leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial activities on a global, multi-country, or regional basis. The CTL is responsible for coordinating and managing the planning, implementation, tracking, and ensuring the clinical deliverables as per the trial contract, budget, timelines and with quality.In this role your key tasks will include:Coordinating and managing CRA activities across all geographies, liaising with sponsor and Project Manager and other functional leads to ensure clinical monitoring deliverables (timeline, budget, quality, productivity) are met, including: Managing the trial start up and site activation in collaboration with PM, Global Regulatory Lead and, if applicable, Global Site Activation Manager (GSAM). Oversight of critical documentation collection, maintenance and filing. Develop the Monitoring Plan and site monitoring templates and tools as well as providing input into Trial plans & tools. Review trial-specific documents upon request as well as develops or reviews subject-facing materials. (if necessary)Customizes the annotated Site Visit Reports according to trial specific requirements. Selection of investigators and sites; SEV report review and approval. Site initiation management; SIV report review and approval Monitoring Visit Report (MVR) review, management, resolution and escalation. Where applicable, works with PM and / or patient recruitment manager to support the project recruitment timelines and (site) recruitment plan as well guiding the CRA team Manages successful trial close-out, identifies critical activities to make timely and efficient close-out. Responsible for timelines, budget and quality of Clinical Monitoring team deliverables, identification of risks and issues and escalation to PM, Line Manager, and GCO management . Provides information and input about planned activities and status to PM and attends Project Review Meetings if/when needed. Conducts project co-monitoring (if required) & if needed temporarily conducts site management / monitoring in case of immediate need and lack of resources. Coaches/mentors CRA team including providing performance feedback as appropriate, assisting in developing and delivering project-specific training and providing input related to Project Specific Training Matrix. Prepares and chairs CRA calls and actively participates in internal trial team calls and client calls. Oversees / attends CRA handovers as appropriate. Serves as a site contact for protocol clarifications and subject enrolment if CRA unavailable. Monitors and manages trial materials supplies ensuring Investigational Product and other trial supplies are shipped to sites.Reviews data listings and query reports to identify trends and ensures proactive re-training is conducted with CRAs and site staff. Oversees the process of protocol deviation and Trial non-compliance documentation, tracking and escalation. Participates in the development of trial newsletters communication. Requests appropriate Clinical Operations staffing, workload and resources and reports trial deliverables and resource needs. Assists, where appropriate, the PM in discussions with clients on trial documentation issues or technical related documentation concerns that may arise. Reviews trial systems (CTMS, CRF, IRS, central lab portal, etc.) updates on regular basis, ensures systems reports are up to date and reports generated are current and correct. Oversees eTMF status. Reviews trial reports and analyzes trends to recognize risks, provides input into mitigation plans and implements mitigations belonging to clinical activities Contributes to optimization of trial processes to increase efficiencyCoordinates and provides support for trial related (site) audits & inspections Contributes to corrective and preventive action plans where needed and ensures their timely implementation and closure Ensures project consistency within and across projects by following Allucent / relevant SOPs.Assists and supports in the preparation of various training material used by Allucent (including SOPs training, as well as specific trial related). Assists in the preparation and conduct of Kick-Off Meetings, Investigators' meetings and other committees' or Trial meetings as requested. Prepares Country Level Site Facing Budgets and manages Investigator and Site Payments as applicable. Supports PM in the management of trial vendors as required. Project contract awareness and oversight; i.e.:Forecast and report on the site management units throughout project life cycleIdentify changes in scope and liaise with the Project ManagerManages client expectations related to Clinical deliverables in accordance with contracted services and Allucent QMS. Provides input into proposals when required. Actively participates in the preparation, attendance and presentation of bid defenses or any other presentations to potential clientsComplete routine administrative tasks in a timely manner (e.g. timesheets, travel expense claims, training)Other responsibilities as required.RequirementsTo be successful you will possess:Candidate must be legally authorized to work in the specified Country where job is being advertised. A degree in life sciences or nursing qualification preferred, but not required A minimum of 5 years clinical research experience (including a combination of SCRA + CTL/CTM, PM or Regulatory/Auditing experience) with at least 1- 2 + years CTL/CTM experience (depending on selected level CTL / Sr. CTL)In-depth knowledge of ICH GCP, clinical trials and the critical elements for success in clinical trialsStrong therapeutic background Possesses experience and knowledge in the CRO industry that will support Allucent's management of clinical trials SkillsStrong written and verbal communication skills including good command of English language Professional and strong client focusedAbility to work in a fast-paced challenging environment of a growing company Administrative excellence with attention to detail and accuracy Leadership and mentoring skills with ability to mentor and train other CRAs in a positive and effective manner Excellent team player with team building skillsStrong organizational skills to be able to manage a full workload across multiple projects.Demonstrates flexibility for creating solutions and process improvement Analytical, financial and problem resolution skills Proficiency with various computer applications such as Word, Excel, and PowerPoint, CTMS, eTMF required Ability to successfully manage people/project issues Mature management skills demonstrated by calm and thorough review of situations. 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Demonstrates the ability to define and meet project requirementsBenefitsBenefits of working at Allucent include:Comprehensive benefits package per locationCompetitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on locationLeadership and mentoring opportunities Participation in our Buddy Program as a new or existing employeeInternal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platformsDisclaimers:Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices."The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."
Sr. Graduate and Alumni Career Development Coordinator
Bentley University, Waltham
Job Description SummaryReporting directly to the Director, Graduate and Alumni Career Development, the Sr. Graduate and Alumni Career Development (GCD) Coordinator’s primary responsibility is to support the day-today operations of the Graduate and Alumni Career Development (GCD) department, within the Strategy & Innovation Division (SID). Our department and division collaborate closely with fellow team members, as well as faculty, staff, and students across campus as we impact the university’s Falcons Forward 2030 strategic plan, build a purposeful and inclusive innovation culture at Bentley, and develop our programs and services to pursue the highest achievable career outcomes for our current students and alumni. The Sr. GCD Coordinator plays a critical role in owning and coordinating key aspects of GCD’s work and will have opportunities to work on a variety of projects and tasks under the direction of the Director of GCD. 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The role will evolve over time to include supervision of Graduate Student Workers.Essential Duties:Graduate Career Development Responsibilities:Provide high level customer service, represent the department, and support relationship-building efforts by serving as a key point of contact. Create a welcoming and inviting atmosphere as the first representative of the department for all constituents, including students, alumni, employers, colleagues, and vendors. Provide administrative support for Director and 3 full time career coaches. This includes, but is not limited to: managing in-coming queries via phone, email and in-person; tracking employer and alumni engagement as it relates to the GCD team in Excel; calendar management; procurement and tracking of budgets, invoices, vendors, conferences, and memberships. Develop opportunities to streamline and improve efficiencies.Coordinate marketing and social media content to build visibility with key audiences and track performance. Develop and recommend content and design for, then execute on weekly graduate student newsletter and monthly alumni newsletters, social media plan, grad and alumni website updates (using Drupal), lobby smart TV, and promotional flyers (using Canva). Offer creative ideas to improve impact.Trained to be a “super user” on office’s career management platforms, Handshake and 12twenty, to help students, employers, and staff understand and maximize their use, in addition to other internal systems (such as Excel and Workday) to track and manage student and alumni data and trends, as well as specified resource platforms (Vmock, Gallop Strengths, Career Leader, Big Interview, Interstride, LinkedIn).Organize and maintain GCD’s document sharing and storage systems on Sharepoint, Teams, and career management platforms.Support success of department programs and events, including managing all logistics: tech and media needs, room bookings, and catering orders; posting event on Handshake or 12twenty; liaise with The Conference Center, facilities, and tech; develop marketing materials, coordinate communications, invites and promotions, and facilitate as needed. As this role matures, the incumbent will partner with the Director on more process improvements; program development, ownership and management; tracking progress toward strategic priorities; and supervision of Graduate Student Workers. Alumni Career Development Responsibilities:Provides support (tracking of attendees, scheduling zoom or in-person rooms) to weekly Alumni Career Strategy group, run by 2 volunteers, and for other alumni events and programs.Track and support Alumni Career Coaching schedule with part-time Alumni Career Coach.Manage alumni email and inquires which may include speaking with employers interested in posting jobs for alumni, following up on leads, and posting the jobs for alumni and/or referring opportunities to the Employer Relations as appropriate.Provide detailed and timely responses to employers and alumni to gain access to alumni resources.Take initiative to streamline and enhance process for increased efficiency for all alumni interactions Other Duties: Other duties as assigned to support the strategic goals of the department and division.Support ad hoc requests from Director and leadership of SID. Minimum Qualifications:High school diploma or GED equivalent required. Associate’s or Bachelor’s degree preferred.Minimum 3+ years of similar program coordinator experienceKnowledge of event planning and Microsoft Office - Outlook, PowerPoint and ExcelExcellent organizational, communication, teamwork and project management skills required.Demonstrated ability to learn and master new technology and platformsCommitted to delivering a high level of customer serviceExcellent communication skills (verbal and written) required and professional presentation (PPT skills preferred)Track record of successfully taking administrative projects from conception to completionAlignment with Bentley values and interests especially regarding a commitment to promoting diversity, equity, inclusion and belonging.Proven skills with Excel, graphic design in PowerPoint, Outlook calendar management, MS Teams. Experience with marketing and promotions preferred.Strong digital communication skills including with social media platforms, especially LinkedIn and InstagramAttention to detail with the ability to work in a fast-paced environmentExperience with anticipating leadership needs and problem-solving preferredSelf-starter and ability to work independentlyMust be detail and data oriented. Strong analytical skills, a plus Work Environment:Typical office setting with extensive sitting and computer work. There will be minimal virtual/remote work and only as approved by manager. Ability to travel within campus and off campus for meetings and other work-related events. Bentley University requires references checks and may conduct other pre-employment screening.DIVERSITY STATEMENTBentley University strives to create a campus community that welcomes the exchange of ideas, and fosters a culture that values differences and views them as a strength in our community.Bentley University is an Equal Opportunity Employer, building strength through diversity. The University is committed to building a community of talented students, faculty and staff who reflect the diversity of global business. We strongly encourage applications from persons from underrepresented groups, individuals with disabilities, covered veterans and those with diverse experiences and backgrounds.PI240620020
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Job DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that positively impacts a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer!Our Single Use Flexibles Solutions Business Unit is part of our Single-Use Division. Our innovative single-use technologies enable customers to accelerate their biological manufacturing processes to build flexibility and operate more dynamically within their upstream and downstream workflows. We provide customers with configurable Bioprocess Containers (BPCs) and fluid transfer assemblies that help ensure manufacturing flexibility and mitigate risk of particulates.The Senior Product Manager develops and implements global product strategies to accelerate the growth of our single use 2D Bioprocessing Containers line. This role also leads the product portfolio's day-to-day tactical aspects, supporting market analysis, planning, and commercial strategy. Key success metrics of this position are revenue growth, portfolio profitability, and new product introductions. A Day in the Life:Lead the life cycle of the existing product portfolio. Responsibilities include driving product line strategies, pricing /margin optimization, management across the customer value continuum, and customer intimacy efforts.Own the revenue and margin targets, overcoming challenges and driving to the targeted forecast.Develop, implement, and run new and/or existing products in a portfolio by creating and implementing product marketing plans, leading New Product Introduction (NPI) teams, and providing data related to competitors, the market, positioning, revenue and unit forecasting, and pricing strategies.An effective performer will maintain close relationships with field organization (e.g., sales and technical support) through training and active participation in the sales process, including customer visits, participating with pricing tactics, and customer support.Champion successful launches through requirements, development, and commercialization.Understand and analyze market environment, including strengths, weaknesses, and product competition. Analyze, interpret, and report regularly to management regarding sales forecasts, product supply, and competition.Serve as product champion and provide strategic direction for all product and portfolio-related projects to other Marketing, R&D, Operations, and Commercial groups.Provide input to business unit annual strategic plan development, including STRAP and AOP.Education:Bachelor's degree in a scientific field or business required. MBA or equivalent experience is highly preferred.Experience:6+ years experience of in life sciences industry, product management, or market developmentBioproduction or Life Sciences industry experience preferred.Experience leading cross-functional teams in a highly matrixed organization and working directly with customers.Strong leadership, project management and planning skills.Experience working with customers, commercial teams and a diverse range of sales channels strongly preferred.Knowledge, Skills, and AbilitiesShown ability to influence and lead convincingly, driving cross-functional teams to succeed in challenging and ambiguous situations. Experienced working in a matrixed organization.Must work well with others - inspires trust and open communication amongst team members and peers. Passionately shares Thermo Fisher Scientific's 4i values.Global mindset, excellent communication and presentation abilities, including strong active listening skills.Results and proactive dedicated, the ability to think critically to overcome potential business hurdles to complete tasks.We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits!Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Business Administrator, Administration & Finance
Bentley University, Waltham
Job Description SummaryReporting to the Director of Divisional Initiatives and Business Management, the Business Administrator, Administration & Finance, supports the Division of Administration & Finance across a range of responsibilities.Essential Duties: This position works closely with the Director of Divisional Initiatives and Business Management and with the Vice President and Chief Financial Officer / Treasurer (VPF) on a wide variety of administrative and important initiatives in the Office of the VPF and across the division. Essential functions include:Partners closely with the Director and the VPF to prepare for meetings and presentations and create presentation materials. Develops reports and presentations to present to the president, cabinet, trustees, and other constituencies.Supports special projects and division wide initiatives. Organizes meetings and events for the VPF and the division.As a key member of the Director’s team, assists the Director with distributing work across the team and oversees select divisional processes that the Business Operations Assistant works on, such as onboarding and offboarding processes.Communications duties may include the design and creation of internal communications vehicles for the division such as newsletters, dashboards, and website maintenance. Will be responsible for creating and maintaining the Office of the VPF website and policy landing page.Supports policy development and dissemination by collaborating with the Director to develop, implement and promote policies, procedures, and guidelines related to the division.Assists with the creation of and monitoring of department budgets; specifically acting as the cost center manager for several areas including the Office of the VPF, the Office of the President, and the Trustees. Assists other VPs at the direction of the Director and VPF. Supports the development, utilization, and advancement of operational and performance metrics, identifies streamlining and efficiency opportunities across all units within the division, and embraces a continuous improvement model.Other duties as assigned.Minimum Qualifications:Bachelor’s degree and a minimum of 4 years administrative and/or financial experience in a fast-paced, complex office environment.Advanced proficiency in Microsoft Word, Excel and PowerPoint.Previous experience managing budgets and operational resources is necessary.Demonstrated ability to relate to individuals at all levels with poise and diplomacy; ability to triage and set priorities, perform multiple tasks simultaneously, maintain confidentiality of sensitive and confidential information, meet tight deadlines, and work under pressure.Demonstrated ability to take initiative, organize, prioritize and manage conflicting goals and agendas. Dedicated team player with strong customer service orientation.Strong written and verbal communications skills.Preferred Qualifications:Previous experience in project management preferred.Work EnvironmentTypical office setting with extensive sitting and computer work.Ability to travel around campus for meetings and work-related events.Possibility of work from home on average 2 day(s) per week.Bentley University requires references checks and may conduct other pre-employment screening.DIVERSITY STATEMENTBentley University strives to create a campus community that welcomes the exchange of ideas, and fosters a culture that values differences and views them as a strength in our community.Bentley University is an Equal Opportunity Employer, building strength through diversity. The University is committed to building a community of talented students, faculty and staff who reflect the diversity of global business. We strongly encourage applications from persons from underrepresented groups, individuals with disabilities, covered veterans and those with diverse experiences and backgrounds.PI241092106
Program Manager, Center for Health and Business (Part-Time 21 hours)
Bentley University, Waltham
Job Description SummaryLaunched in October 2023, based off the former Health Thought Leadership Network, the Bentley Center for Health and Business (CHB) focuses on impactful education, actionable research and meaningful collaborations. The CHB is currently in a major growth phase with new programs/initiatives for learners at all levels, international research collaborations/workshops and a presence at global events highlighting our growth, capacity and perspectives on the business of health.Reporting to the Program Director, this position supports the administrative and operational activities of the Center. Duties include managing all events and workflow in the Center, take a lead role in managing/mentoring student workers, identify opportunities for marketing and promotion of the CHB, oversees data management, primary interface with other University departments and CHB affiliates, manages the website and social media presence, assist with reconciliations of financials with the Business Service Center, management of CHB programs and additional tasks as assigned. As a key member of multiple new programs at Bentley, we are looking for an enthusiastic and creative team player who seeks opportunities to lead and can work independently. Willingness to learn is extremely important in this newly created role.Essential DutiesAdministrative OversightAct as primary contact for internal and external associates.Prepare reports, memos, brochures, schedules, expense reports, correspondence and other documents.Make travel arrangements as needed.Manage team calendars when appropriate.Manage data associated with department programs.May prepare presentation materials.Hire, train, submit time and supervise student employees.Data ManagementContinue to build the CHB database by inputting information on events, connections, impact metrics and networks.Create and update process management documents.Collaborate with Bentley’s Marketing Department on further enhancing our presence.Program ManagementManage programs and events for the CHB, including planning and executing.Participate in planning and execute marketing plans and program logistics.May attend meetings or events and document content.May design, gather and summarize program evaluations.Maintain current website and its content, strategize and develop targeted marketing materials for each of the CHB's programs and events, build beneficial relationships with all departments on campus, as well as the 90+ CHB affiliates.Financial SupportWork with the Business Service Center to reconcile CHB transactions, process invoices, create spend authorizations, expense reports and other financial transactions as needed.Marketing/Website and Social MediaManage current website, implement social media marketing and outreach, and design materials for e-marketing or print publications.Attend training on Drupal and social media.Create newsletters biannually.Manage students to create and post social media content. Minimum QualificationsA bachelor’s degree.Two to four years of work experience.Excellent project management skills, ability to manage multiple competing priorities in a rapidly changing environment.Excellent interpersonal and leadership skills.Established computer/tech skills (Word, Excel, Outlook, PowerPoint, OneDrive, Teams, Google Drive, Zoom).Established social media skills (such as Twitter, Instagram, LinkedIn, and other social media). Experience with Drupal a plus.Prior Workday software experience a plus.Outgoing self-starter and ability to work independently.Must have strong work ethic, be detail oriented and can present information clearly, concisely and objectively.Must demonstrate initiative and dedication to finishing tasks expediently/when due; must have excellent follow up and follow through skills.Must be respectful and aware of diversity of the student, staff and faculty population; make effort to work with cultural differences and open to learning about such differences.Work EnvironmentTypical office setting with extensive sitting and computer work.Academic institution with an inviting and vibrant campus community focused on using business for good.Ability to travel around campus for meetings and other work-related events.Position will require some night and weekend responsibilities, including representing the CHB at events, approximately once monthly on average.This position is primarily in the office. Virtual/remote work can be discussed. Flexible work environment & hours can be discussed after an evaluation period.Bentley University requires references checks and may conduct other pre-employment screening.DIVERSITY STATEMENTBentley University strives to create a campus community that welcomes the exchange of ideas, and fosters a culture that values differences and views them as a strength in our community.Bentley University is an Equal Opportunity Employer, building strength through diversity. The University is committed to building a community of talented students, faculty and staff who reflect the diversity of global business. We strongly encourage applications from persons from underrepresented groups, individuals with disabilities, covered veterans and those with diverse experiences and backgrounds.PI241168676
Manager, Marketing Communications
Thermo Fisher Scientific, Waltham
Job DescriptionManager Marketing CommunicationsR-01249569 *This will be a site based role in Waltham, MA*We are looking for a bold and upbeat Marketing Communications (MarCom) Manager. As a MarCom Manager at our company, you will support a cross functional team in the development and execution of various communications and campaign materials to deliver exceptional results across multiple geographies and support our strategic goals and targets.In this position you will play a key role in providing communications expertise while closely working with business partners from marketing and product management, as well as cross-functional teams and external vendors to implement collateral.If you are a hard-working, organized and creative person who can think strategically while also being able to working on details of a specific project, and you love to plan, organize and interact with people, we would love to hear from you! Key Responsibilities:Support marketing strategies, campaigns and tactics focused on delivering the write message to our customersLead communication plans throughout the year to ensure projects are initiated on time, and completed on target and within budgetCommunicate and collaborate effectively with Product and Marketing Managers and other cross-functional teams (Digital, Regional, R&D, Tech Writers, etc.)Write clear, streamlined, customer-focused creative briefs, as neededInfluence the creation of content for marketing collateral including white papers, presentations, case studies, eBooks, protocols, videos, selection guides and customer success storiesWrite, edit and proof brochures, spec sheets, application notes, case studies, mailers, product announcements, presentations and web contentChampion global editorial calendar development and managementCreate and optimize sales enablement tools to ensure proper utilizationAnalyze and report effectiveness of materialsBuild long-term relationships with influencers and key collaboratorsStrong project management, relationship management, and critical thinking skillsEnsure and monitor global brand, regulatory and legal complianceSkills, Qualifications & Requirements: 5+ years' work experience in a similar role and field (marketing, communications, marketing communications or agency) requiredBachelor's or master's degree in marketing, Communications, Business Administration, Management or equivalent preferredIndustry knowledge a plusExperience working in a matrixed organizationWork both independently and as part of a teamExcellent communication, presentation and interpersonal skillsStrong project management and organizational skillsExtremely detail-orientedHigh level of intensity and comfort level with changeExceptional copy writing and editing skillsStrong computer skills required, experience with project management and budgeting software a plusTravel up to 5%, domestic or internationally
Facilities Project Manager
US Tech Solutions, Waltham
Duration: 12 monthsJob Description:The Hard Services Project Manager will lead small projects or support large programs, utilizing project management methodologies, tools, and templates to ensure seamless transition from project phase to operational phase. They will collaborate with cross functional teams to align project goals with operational needs, oversee the planning, execution, and delivery of hard services, and develop and implement comprehensive operational readiness plans. Regular updates and reports on project status and risks will be provided to stakeholders to ensure alignment with business requirements and operational efficiency.Key Responsibilities:• Oversee the planning, execution, and delivery of facilities management services for the new R&D lab/office site.• Ensure the seamless transition of hard services from project phase to operational phase.• Collaborate with construction, engineering, and facilities teams to align project goals with operational needs.• Manage and coordinate maintenance, utilities, and infrastructure systems to ensure they meet operational standards.• Develop and implement facilities services readiness plans, including commissioning and handover processes.• Monitor project progress, identify potential issues, and implement corrective actions as needed.• Ensure compliance with all relevant health, safety, and environmental regulations.• Provide regular updates and reports to senior management and stakeholders.• Develop scope for third party service providers.• Ensures that all work is carried out with regards to standards and external regulations.• Ensures efficient and effective management of project information, quality of data and integrity of information supplied.• Works within the governance structure of the KSQ program.Required Skills:• Strong project management skills, including planning and scheduling for complex projects.• Proficiency in project management software to develop and manage schedules.• Excellent communication and Required Skills:interpersonal skills to effectively collaborate• Exceptional organization and time management skills to prioritize tasks• Attention to detail and a commitment to accuracy in maintaining schedules.• Ability to work well under pressure and adapt to changing priorities and requirements.• Strong leadership skills with the ability to influence to achieve project goals.• Indepth knowledge of hard services, including HVAC, electrical, plumbing, and building management systems.Required Qualifications :• Bachelor's degree in facilities management, business administration, engineering, or a related field.• Certification in project management, such as PMP (Project Management Professional), is highly desirable.• Proficient in the use of project management software.• 5 years of experience in facilities management, in a lab environment.• Experience with commissioning and operational readiness processes.• Ability to work independently and collaboratively in a teamoriented environment.• Experience in establishing facilities management organizations and initiating operations at new sites.• Attention to detail and a commitment to accuracy in maintaining and updating schedules.Education and Experience:Bachelor's degree in facilities management, business administration, engineering, or a related field.About US Tech Solutions:US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Recruiter Details:Name: AishwaryaEmail: [email protected] Id: 24-12207
Validation Engineer (CSV)
GQR, Waltham
Title: Validation Engineer (CSV)Location: Waltham, MAStatus: 6-month contractHourly rate: $60Please note that this role is not able to provide sponsorship or work on a C2C basis.Position Overview:The Computer System Validation Specialist will support the validation activities for computer systems and computerized equipment, ensuring compliance with policies and procedures. This role encompasses both local and global enterprise systems, as well as SaaS (Software as a Service) solutions, and reports to the Manager of Validation.Key Responsibilities:Conduct validation activities, including requirements gathering, validation planning, design qualification, test plan and script creation, test script execution, discrepancy management, and preparation of system descriptions and validation summary reports.Perform system-based risk assessments to determine GxP applicability, assess associated risks, and define validation activities based on risk levels.Assist the Validation Team with all aspects of the computer system and computerized equipment lifecycle during projects and operational phases, including the development, review, and execution of validation documentation.Provide validation support during the operational phase by conducting change impact assessments, determining required testing levels, authoring and executing test scripts related to changes, and preparing change qualification reports.Support periodic reviews of computer systems and user access reviews for computerized equipment.Assist in the business administration of the electronic validation lifecycle management system (ValGenesis).Train end users on the ValGenesis system.Manage and update validation templates in ValGenesis.Qualifications:Bachelor's degree in a Science or Engineering discipline.Minimum of 5 years of relevant experience in computer system validation.Experience with computer systems supporting R&D functions such as Clinical, Pharmacovigilance/Drug Safety, Medical Affairs, Supply Chain, Regulatory Affairs, and Quality Assurance is advantageous.Familiarity with ValGenesis is a plus.Practical experience with quality risk management and risk-based validation approaches.Knowledge of cGMP regulations and guidelines, including U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9, and Q10.Understanding of industry standards and best practices for computer system validation, such as GAMP 5 and ASTM E2500.Skills and Abilities:Ability to objectively review and make judgments within the wider context of quality and compliance.Strong troubleshooting skills.Effective collaboration and teamwork with cross-functional teams.Capability to manage a high volume of simultaneous projects and validation activities.This role is critical in maintaining the integrity and compliance of computer systems and ensuring they meet regulatory standards and internal policies.
CSV/ Validation Engineer
Beacon Hill Staffing Group., Waltham
Beacon Hill Life Sciences is partnering with a Biotechnology company in the Boston area who are seeking a CSV/Validation Engineer to join their team. This is a contract through the end of the year and will be hybrid- must be able to commute on-site to Waltham, MA 2-3 days per week. KEY AREAS OF JOB ACCOUNTABILITY: The holder of this position is charged with supporting computer system/computerised equipment validation activities and ensuring compliance with company policies and procedures. Position scope includes local and global enterprise systems as well as SaaS (Software as a Service) solutions. This role will report into the Manager of Validation.Perform validation activities supporting requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports.Perform system-based risk assessments in determining GxP applicability of the system, associated risk and resulting validation activities per risk.Support Validation Team on all aspects of the computer system/computerised equipment lifecycle during projects and operational phase, including but not limited to development, review and execution of validation documentation.Provide validation support during the operational phase by performing change impact assessments, determine the required level of testing, authoring and executing test scripts related to the change and change qualification report.Support periodic review of computer systems.Support periodic user access review of computer systems/computerised equipments.Support business administration of the electronic system (ValGenesis) used for validation lifecycle management.Support training of end users on the electronic system (ValGenesis) used for validation lifecycle management.Support management of Validation Templates in ValGenesis in terms of authoring/updating templates.ACADEMIC/TECHNICAL QUALIFICATIONS:Bachelor's degree in a Science or Engineering discipline required5+ years relevant experience in computer system validation.SPECIALIST/TECHNICAL QUALIFICATIONS/KNOWLEDGE:Experience computer systems supporting R&D functions like Clinical, Pharmacovigilance/Drug Safety, Medical Affairs, Supply Chain, Regulatory Affairs and Quality Assurance is a plusExperience with ValGenesis is a plusPractical experience with quality risk management and risk-based validation approaches.Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10. Understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500ABILITIES AND JUDGEMENT:? Ability to objectively review.? Ability to make judgements in the wider context of quality/compliance? Ability to perform effective trouble shooting? Ability to collaborate and work with cross-functional teams? Ability to manage high volume of simultaneous projects/validation activitiesRelocation is not approved for this posting. This is a hybrid position.Please apply with your updated resume and contact information to be considered. Thank you for your time and interest!