17:I[59529,["/_next/static/immutable/chunks/2corl6wyj4669.js","/_next/static/immutable/chunks/31r--0f39g9ze.js","/_next/static/immutable/chunks/0ecdjrtw9-w3j.js","/_next/static/immutable/chunks/1nbyhb2cfdaol.js","/_next/static/immutable/chunks/1hodejexxhw_x.js","/_next/static/immutable/chunks/39f9_79wvgc2y.js"],"default"] 18:T779,

Target PR Range: 19-28/hr DOE

Job Details:Bachelors’ degree & 2 YOETo perform experiments, organize data and analyze results under minimal supervision. With minimal supervision, plans, conducts or monitors experiments, records and organizes data, analyses results, generates robust and reliable data and/or Ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.

Responsibilities include:
Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision
Plans, monitors or conducts, analyzes and records experiments, and provides interpretation of data
Effectively transfers experimental methods from literature to the lab and makes modifications as necessary
Develops and implements new protocols with moderate review
Engages coworkers in scientific discussions ? Communicates data and interpretation to work group
Skilled at developing systems to ensure quality data
Skilled and/or knowledgeable in the use of standard laboratory equipment and with one or more major laboratory instruments/techniques ? Effectively trouble-shoots equipment and experimental difficulties
Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents
Participates in department-wide support efforts such as safety, recruiting and committees
May train staff and/or supervise others
Coordinates and organizes resources needed to complete the task
Understands when to seek input and when to make independent judgments;

Skills: ; degree in Biology, Biochemistry or Analytical Chemistry ; experience in a Biopharmaceutical working environment

19:T1786,

Top 3 technical skills that are required for the role:
1. Lead, support, review and approve supplier change request (SCR), Validation, TMV, PPAP, SCAPA, QMS etc.
2. Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities Quality Plans, Control Plans, and FMEAs
3. Familiar with the Medical industry requirements such as ISO 13485, 21 CFR 820 standards etc.

Education Required:
Years’ Experience Required: Bachelor’s Degree in Engineering/Scientific/Electronic or technical field
Years’ Experience Required: Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience .

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hrs weekly

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite. Location: 60 Middletown Ave, North Haven, CT 06473

What is your timeline for scheduling interviews? Now.

What product line will this person support?
Robotic Surgical Technologies support contract manufacturer

Must Have Technical Skills:
* Bachelor’s degree in mechanical/production engineering with Min 9-12 years of relevant experience.
* Strong expertise in DFM&A principles and manufacturing methods for plastics, metals, and packaging components & Systems.
* Proven experience in analyzing project feasibility for cost savings and efficiency improvements.
* Proficiency in CAD – Creo/SW and PLM/PDM tools (preferably Windchill).
* Solid understanding of project management methodologies, including planning, tracking, and cross-functional collaboration.
* Strong verbal & presentation skills for effective collaboration with global teams.
* Well versed with MS Powerpoint, Excel for reports preparation, data analysis/advance operations.
* Proficient in conducting Production Part Approval Process (PPAP) to ensure compliance with technical specifications and quality standards.
* Skilled in performing detailed Root Cause Analysis to identify issues, implement corrective actions, and drive continuous improvement.

The Supplier Quality Engineer is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies. Primary duties are focused on all QMS related matters pertaining to supplier selection, processing supplier change request, part/process qualification, manufacturing, QMS development, and technical quality/service/costs improvements. Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, PPAP, SCR, Quality Plans, Control Plans, and FMEAs

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

1a:Td21,

Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

* Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
* Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
* Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
* Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
* Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
* Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
* Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
* Act as a mentor for clinical staff including conducting co-monitoring and training visits.
* Collaborate and liaise with study team members for project execution support as appropriate.
* If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
* If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

* Bachelor’s Degree Degree in scientific discipline or health care preferred. Req
* Requires at least 4 years of year of on-site monitoring experience.
* Equivalent combination of education, training and experience may be accepted in lieu of degree.
* In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
* Strong therapeutic and protocol knowledge as provided in company training.
* Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
* Written and verbal communication skills including good command of English language.
* Organizational and problem-solving skills.
* Effective time and financial management skills.
* Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
* Ability to travel about 70% of the time 1b:Tecb,

This person will be responsible for validating and qualifying new packaging materials (foil, Tyvek, film) for absorbable suture products. They will be responsible for process development activities and creating the validation plans in compliance with company standards. They will be the project lead and communicate project deliverables and timing to engineering management.

Top 3 technical skills that are required for the role:

Packaging Experience
Validation Experience – Process Development, OQ, IQ, PQ
Familiarity with Cognex and Keyence based vision inspection systems

Education Required: BS (or above) Engineering Degree; Mechanical, Manufacturing, Packaging

Years’ Experience Required: 3-5

Responsibilities may include the following and other duties may be assigned. Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques. Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

1c:Te65,

PR: 53-57.50

HM’s Top Needs:

1. Strong Clinical Evaluation experience, writing Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Follow Up Plan (PMCF P), Post Market Follow up Report (PMCF R), Summary of Safety Clinical Performance (SSCP), Periodic Safety Update Report (PSUR)

2. Strong project management skills

3. Strong proactive communication skills

Education Required: Baccalaureate degree and minimum of 4 years relevant experience OR advanced degree with minimum of 2 years relevant experience

Years’ Experience Required: see below

Will the contractor be working 40 hours a week? If not, weekly estimate?

Work Location: Remote

Do they need to be local to any MDT office and if so where? No

Does this person need to be on site? If so, full time or part time? No

Job Description:

The Senior Clinical Evaluation Medical Writer is responsible for authoring, reviewing, and managing clinical evaluation documents and reports in compliance with regulatory requirements and industry standards. This role involves synthesizing clinical data, scientific literature, and regulatory guidelines to create clear, concise, and evidence-based documentation that supports the safety and performance of medical devices. The writer collaborates closely with cross-functional teams to ensure the timely delivery of high-quality clinical evaluation reports (CERs) and related documents. Strong analytical skills, attention to detail, and the ability to communicate complex medical and scientific information effectively are essential for success in this role.

Job Responsibilities:

· Review and summarize scientific literature

· Appraise, analyze, summarize, and discuss clinical evidence from all the available sources.

· Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence.

· Maintains database of peer-reviewed literature.

· Develop state of the art (SOTA) on product family for its intended purpose.

· Create & maintain plans and reports for regulatory authorities, including but not limited to Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up Plans (PMCF-P), Post-Market Clinical Follow-up Reports (PMCF – R), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR).

· Reports instances of complaints/adverse events from literature.

· Create responses for audit/submission queries.

Job Requirements:

· Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.

· Experience writing clinical evaluation documents

· Medical Device experience

· Strong project management skills

· Strong communication skills

· Ability to deliver and manage projects assigned and work with other stakeholders to achieve desired results.

· Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

1d:Tdc7,

Job Description
The Customer Experience Specialist plays a critical role in ensuring a seamless order-to-delivery experience for customers. This position serves as a key liaison between customers, sales, logistics partners, and internal operations teams to ensure accurate order processing, timely shipments, and proactive communication.
The role combines strong customer service skills, logistics coordination, and operational problem-solving to support efficient supply chain execution and maintain high levels of customer satisfaction.

NOTE: This role is a hybrid position that is a combination of an onsite requirement and a remote aspect. All candidates must be within commuting distance of the Woburn, MA office and have flexibility to come to the office as needed
Job hours; M-F, 12:00 PM – 8:30 PM

Key Responsibilities
Customer Service & Order Management

*   Serve as the primary point of contact for customers regarding orders, delivery timelines, and product availability.
*   Process and manage customer orders within ERP systems, ensuring accuracy and completeness.
*   Provide timely responses to customer inquiries, including order status, shipping updates, and product information.
*   Maintain accurate customer records and order documentation.
*   Coordinate closely with the sales team to support customer needs and ensure alignment on order fulfillment.

Logistics & Shipment Coordination

*   Coordinate shipments with internal warehouse teams, third-party logistics providers, and freight carriers.
*   Monitor order fulfillment and shipment status to ensure on-time delivery.
*   Track and resolve shipping issues, delays, or discrepancies in a timely manner.
*   Prepare and review shipping documentation including packing lists, invoices, and export documentation where applicable.
*   Support international shipments and ensure compliance with applicable import/export requirements.

Order-to-Delivery Process Support

*   Monitor the end-to-end order lifecycle from order entry through delivery confirmation.
*   Identify potential supply chain disruptions and proactively communicate updates to customers and internal stakeholders.
*   Work cross-functionally with operations, planning, finance, and quality teams to resolve order issues.
*   Assist with backlog management and delivery prioritization.

Continuous Improvement

*   Identify opportunities to improve order processing, logistics coordination, and customer communication.
*   Participate in process improvement initiatives such as Kaizen or operational workflow improvements.
*   Support documentation of customer service and logistics processes.
*   Contribute to performance tracking metrics such as on-time delivery, order accuracy, and customer satisfaction.

Qualifications

*   5+ years of experience in customer service, order management, logistics, or supply chain operations.
*   Experience working with ERP systems (SAP, Oracle, NetSuite, or similar). Strong preference for SAP
*   Strong understanding of order processing and logistics coordination.
*   Experience working with freight carriers and logistics providers preferred.
*   Proficiency in Microsoft Office, particularly Excel.

Pay Rate Range: $30-35/hr depending on experience

1e:T20df,

Position Summary:
The Senior Manager, Drug Safety & Pharmacovigilance (DSPV) will support pre- and post-marketing pharmacovigilance activities across both DSPV Operations and Safety Science. This position will be responsible for supporting day-to-day safety operations, including individual case safety report (ICSR) management, vendor oversight, regulatory reporting compliance, quality and compliance monitoring, and safety data reconciliation. The Senior Manager, DSPV will also support safety scientist activities, including medical review of ICSRs, clinical safety data review, signal detection and assessment, preparation and review of aggregate safety reports, review of safety information in clinical and regulatory documents, and contribution to risk management and product labeling activities.

Responsibilities:
PV Operations and Compliance

Manage the day-to-day pharmacovigilance operations performed internally and by PV service providers, including clinical trial and post-marketing case processing activities.
Monitor compliance with global regulatory requirements and reporting timelines for expedited safety reports.
Perform quality review of ICSRs, safety forms, narratives, and other safety documentation to ensure completeness, accuracy, consistency, and regulatory compliance.
Monitor PV vendor performance, including review of key performance indicators (KPIs), compliance metrics, quality findings, and operational issues, and facilitate timely resolution and escalation as appropriate.
Perform safety data reconciliations, including SAE reconciliation with clinical databases, vendor reconciliations, and other safety data reconciliation activities.
Support PV activities involving business partners and licensing partners to ensure compliance with pharmacovigilance agreements, Safety Data Exchange Agreements (SDEAs), contracts, and applicable procedures.
Support the development and maintenance of safety-related plans, including Safety Management Plans, Vendor Oversight Plans, and SAE Reconciliation Plans.
Lead or coordinate investigation of PV deviations and quality events and drive the development, implementation, and effectiveness monitoring of corrective and preventive actions (CAPAs).
Support PV inspection and audit readiness activities and maintain pharmacovigilance documentation in an inspection-ready state.
Participate in regulatory inspections and internal or external audits involving pharmacovigilance, including preparation of requested documentation and responses to findings.
Contribute to the development, revision, and implementation of PV SOPs, Work Instructions, procedural documents, and training materials.
Support departmental project management activities, including safety team meetings, tracking deliverables and timelines, meeting documentation, and appropriate archiving of PV records.

Safety Science and Medical Review

Perform medical review of ICSRs from clinical trials and post-marketing sources, including review of adverse event coding, seriousness, expectedness, causality, narratives, listedness, and overall case quality.
Contribute to ongoing medical and safety review of clinical study data and identify safety findings, trends, inconsistencies, or potential issues requiring further evaluation.
Review MedDRA coding and other safety-related coding of clinical and post-marketing data, as appropriate.
Contribute to the planning, preparation, authoring, review, and quality control of aggregate and periodic safety reports, including DSURs, PADERs, PSURs/PBRERs, periodic line listings, and ad hoc safety analyses.
Review and contribute to safety sections of key clinical and regulatory documents, including Investigator’s Brochures, clinical study protocols, informed consent forms, statistical analysis plans, clinical study reports (CSRs), and other relevant documents.
Support routine safety signal management activities, including review of adverse event data, aggregate data, literature, regulatory information, and other relevant safety sources; evaluation, validation, assessment, documentation, and tracking of potential safety signals in accordance with company procedures and applicable global regulatory requirements.
Assist in the development and maintenance of Risk Management Plans and other risk-management documentation.
Support preparation and review of responses to health authority inquiries and requests for information related to product safety.
Support REMS activities, where applicable, including operational activities, vendor oversight, review of REMS materials, and compliance monitoring.
Act as the DSPV subject matter expert in cross-functional safety governance activities and safety review meetings, as assigned.
Additional duties assigned as needed.

Education/Experience Requirements:

Bachelor’s degree in life sciences or related field required. Healthcare professional or relevant health/biomedical science degree; RN, BSN, PharmD, PA, NP, or similar healthcare-related qualification preferred, particularly for responsibilities involving medical review of safety cases. Equivalent combination of education and applicable job experience may be considered.
6+ years of experience in Drug Safety/Pharmacovigilance within the pharmaceutical, biotechnology, or CRO industry, with experience in both clinical development and post-marketing pharmacovigilance environments.
Strong experience with ICSR processing and/or medical review, including assessment of seriousness, expectedness, causality, coding, case narratives, and query management; and regulatory reporting compliance.

Additional Skills/Experience:

The ideal candidate will embody company core values: Courage, Community Spirit, Patient Focus and Teamwork.
Driven, intelligent, passionate about making a difference for patients with rare diseases.
Experience with reconciliation activities, case quality review, and vendor oversight.
Experience with safety surveillance and signal detection activities.
Experience contributing to aggregate safety reports such as DSURs, PADERs, PSURs/PBRERs, and other periodic or ad hoc safety analyses.
Experience reviewing safety information in clinical study documents, including protocols, Investigator’s Brochures, informed consent forms, CSRs, and safety data outputs.
Experience with pharmacovigilance/safety database systems such as ARGUS, ARISg, or equivalent systems.
Experience in MedDRA and WHO Drug coding conventions.
Working knowledge of FDA regulations, ICH guidelines, GCP requirements, EU pharmacovigilance requirements, and other applicable global requirements for clinical and post-marketing safety.
Knowledge of REMS programs and/or REMS program management preferred.
Strong analytical and critical-thinking skills with the ability to interpret individual and aggregate safety data and identify potential safety issues.
Strong written and verbal communication skills and the ability to communicate safety information clearly to cross-functional stakeholders.
Ability to work independently while effectively collaborating in cross-functional and matrixed team environments.
Strong organizational, prioritization, and time-management skills with the ability to manage multiple projects and competing priorities.
Detail-oriented with a strong commitment to data quality, regulatory compliance, and timely execution.
Proficient in Microsoft Word, Excel, and PowerPoint.
Experience in nephrology and/or rare diseases is preferred.
Ability to travel 10% domestically and internationally, including occasional nights and weekend travel.
All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Comp based on experience $132-172K

1f:Ta9c,

Target PR Range: 90-100/hr DOE

Summary of Position:

Reporting to the Global Medical Information Lead, the Medical Information Manager will be responsible for developing, managing, and delivering high-quality, accurate, and compliant medical content to support HCPs. You will also ensure timely and accurate responses to medical inquiries across our therapeutic areas. This role necessitates a comprehensive understanding of medical information with a strong emphasis on project management, medical writing, and strategic thinking.

Position Responsibilities:

· Support the creation and approval of Medical Information content including FAQs, SRLs, and Custom Response documents.

· Ensure the MICC agents are equipped with up-to-date scientific content.

· Review and triage Medical Information Request Forms (MIRFs) submitted by MSLs ensuring accurate, timely, and compliant delivery of medical responses in alignment with internal processes.

· Monitor and analyze inquiry trends and insights to inform scientific communications and strategic planning.

· Partner with cross-functional teams to ensure scientific accuracy and compliance with regulations.

· At times, serve as a member of the Medical Review Committee and Promotional Review Committee to ensure scientific accuracy of Medical and Promotional assets.

· Provide support to ongoing global medical congress initiatives.

Other duties within broader Scientific Communications as periodically assigned.

Candidate Requirements:

Advanced degree in life sciences (e.g. PharmD, PhD, MD, or equivalent required).
Minimum of 3 years of relevant experience in Medical Information, Medical Communications, or related function in the biotech industry.
Experience in content creation, review, and approval processes; strong knowledge of regulatory guidelines and compliance requirements.
Strong scientific writing and written communication skills.
Ability to interpret clinical data and present it clearly and accurately.
Ability to thrive in a fast-paced environment with strong ability to simultaneously handle multiple activities, prioritizing and pivoting as necessary.

*CO/NYC candidates might not be considered

20:T821,

Target PR Range: 59-69/hr
*Depending on experience

As the Marketing Specialist you will own the hands-on technical build, dynamic coding, data integration, and deployment of automated donor journeys and campaign communications. Sitting within the Digital Experience team, you will act as the technical builder in Salesforce Marketing Cloud (SFMC), translating strategic lifecycle blueprints into highly functional, personalized, and deliverable email experiences.
You will write dynamic code using AMPscript, SSJS, and SQL to leverage data from Data360 and Health Cloud, ensuring precise audience targeting and personalized touchpoints for donors. You will collaborate closely with the Email Designer, strategy leaders, and cross-functional teams to build, QA, test, and deploy inbox-ready communications that drive engagement, conversion, and retention.

You will report to the Senior Manager, CRM Lifecycle Strategy, with no direct reports.

Minimum Requirements:

* Bachelor’s Degree in Computer Science, Web Development, Marketing Technology, or equivalent combination of education and experience.
* 3+ years of hands-on technical email development within Salesforce Marketing Cloud.
* Proven proficiency with AMPscript, SQL, HTML, CSS, and Server-Side JavaScript (SSJS).
* Strong technical experience with SFMC Content Builder, Journey Builder, Automation Studio, and Data Extensions.
* Experience with SFMC Data Cloud integration and complex B2C audience segmentation preferred.
* Experience working within Jira for sprint planning and workflow management.
* Familiarity with email client rendering quirks, inbox deliverability factors, and accessibility best practices.
* Travel: Up to 30% as required.

Additional Expectations:

* High degree of organization and attention to detail.
* Ability to perform in a fast-paced environment with frequent interruptions.
* Technical proficiency with marketing platforms

*CO/NYC candidates might not be considered

21:Te92,

Job Description:

The Clinical Research Associate conducts site monitoring responsibilities for Clinical trials, according to Standard Operating Procedures, ICH guidelines, and GCP.

Essential Duties and Responsibilities:

Manage and monitor site activities for assigned clinical studies, working individually or co-monitoring with other Clinical Research Associates (CRAs).
Monitoring activities will include but not be limited to site qualification, site initiation, interim monitoring, and close-out visits.
During monitoring visits, the CRA ensures compliance with the protocol and applicable Company or Sponsor Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines.
Perform site evaluation visits of potential investigators. Evaluate the capability of the site to successfully manage and conduct the clinical study.
Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the case report forms, monitoring activities and study close-out activities.
Assist in resolving any issues to ensure compliance with site file audits.
Direct communication with investigational sites on visit planning, query resolution, action item resolution, and any other activities to support site management.
Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Perform investigational product inventory. Ensure return of unused materials to designated location or verify destruction as required.
Serve as primary contact with the site; coordinate all correspondence; ensure timely transmission of clinical data with the study site.
Perform study close-out visits per the study specific Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
Ensure internal and study-related trainings are completed per Lotus and/or study timelines.
Pre and post visit follow up include compliance to timelines indicated in the Monitoring Plan (MP) for Confirmation Letters, Follow up Letters and Monitoring Visit Reports (MVR).

Education and/or Experience:

Bunionectomy experience required
Ability and willingness to travel up to 75% of the time (land and air).
College degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
In lieu of the university /college degree or certification requirement, a minimum of 5 years of relevant clinical research experience in health care, pharmaceutical, or CRO settings may be considered and minimum of 2 years field monitoring experience as a CRA.
Phase I experience preferred
Valid Driver’s License.

Skills and Abilities:

Proficient knowledge of the drug development process, ICH guidelines, GCP, and the clinical trial process.
Experience using electronic CRF platforms and processes.
Exceptional attention to detail.
Ability to interact effectively within and across team environments.
Excellent organizational skills.
Proficient computer skills with good working knowledge of a range of standard computer software required (e.g., email, document, spreadsheet, and presentation software).

22:Tb3c,

Job description

The Manufacturing Engineer owns engineering support for our manufacturing operations. The role takes processes and equipment from specification and validation through scale-up, and then keeps improving them in day-to-day production, while staying compliant with FDA QMSR (21 CFR 820) and ISO 13485.

Primary Responsibilities

Process development and scale-up

Set up new manufacturing processes and improve existing ones.
Lead scale-up and commercialization of new processes so they hit targets for yield, capacity, throughput time and productivity.
Help design and build lean production lines, with attention to flow, throughput time, material movement, layout and space.
Work with R&D, Quality and Operations so products move from development through approval and into production smoothly, on time and cost-effectively.

Equipment and validation

Own the equipment lifecycle: specification, procurement, installation and validation.
Write and run Factory Acceptance Tests (FATs), both on-site and at vendors, for equipment used in processes where we own the product or process design.
Write and execute IQ/OQ/PQ protocols and reports for equipment, process and product validations, in line with regulatory requirements.
Set up preventive maintenance and calibration programs.

Documentation and materials

Create and maintain manufacturing documentation: equipment files, pFMEAs, TMVs, bills of materials, part numbers, product routings, manufacturing procedures and logs.
Specify and order the components, consumables and materials needed for validation and production.

Production support and training

Provide daily engineering support to Production, and keep driving better operating performance without compromising regulatory compliance.
Lead knowledge transfer for new processes and train product builders and technicians.

Qualifications

Bachelor’s degree in engineering (mechanical, biomedical, chemical or manufacturing preferred) or equivalent.
1+ years in a manufacturing or process engineering role. Medical device or other regulated-industry experience strongly preferred.
Hands-on experience with process validation (IQ/OQ/PQ), equipment qualification and pFMEA.
Strong technical writing skills, with a record of producing protocols, reports and procedures.
Execution-focused: comfortable moving between hands-on work and guiding technicians and cross-functional partners.

23:T14ce,

Target PR Range: 86-96/hr
*Depending on experience

As a Manufacturing Program Manager, you are responsible for leading large programs that involve multiple manufacturing, testing and storage locations across the globe.

The scope of the programs you lead typically includes assembly, labeling, packaging, testing, storage and release of new or modified medical devices and drug-device combination products.

You are responsible for creating and implementing program execution strategies, creating and maintaining program milestones and timelines, facilitating product and design transfer kick-off meetings, aligning global and site cross-functional project execution teams, planning material use, sourcing and distribution across the network, enabling regulatory submissions and supporting product launches.

Your role involves turning business goals into actionable project plans, establishing clear deliverables and milestones, communicating to stakeholders, removing barriers to success, managing risks, and driving collaboration across Manufacturing, Engineering, Science & Technology, Supply Chain, Quality and Regulatory.

You are expected to be a proactive, organized, leader with executive presence and strong communication skills that enable achievement of program goals and delivery of exceptional value.

Responsibilities:

Using a collection of program management tools, independently define and document the program scope, execution strategies, resources, deliverables and milestones.
Manage the program per its approved financial plan, ensuring that actual charges post as anticipated and communicate/resolve any financial variances.
Articulate the program execution strategy, deliverables and milestones to appropriate internal and external stakeholders maintaining a clear, consistent narrative to foster engagement, understanding and alignment.
Work collaboratively with the program team to implement effective program governance structures, work breakdown structures, roles and responsibilities, integrated timelines and communication plans.
Develop risk mitigation and contingency plans; implement as needed to keep the program on track.
Identify and realize opportunities that result in acceleration, efficiency and cost avoidance/reduction. Understand and integrate changes in the global landscape for device and combination product industrialization, global quality and regulatory requirements and pathways for approval/market access in programs to deliver acceleration and value.
Ensure the program team and stakeholders are aligned and the program is being executed efficiently. Manage competing timelines and make difficult decisions regarding priorities across the program. Drive rapid identification, communication and resolution of issues. Enable informed decision making, robust cross-functional problem solving and continuous improvement of program management practices and tools.
Plan and facilitate global meetings, document minutes and actions, follow-up on closure, and hold team members accountable for decisions and deliverables.
Ensure that programs and projects are technically and financially closed out upon completion and any on-going responsibilities are formally transferred to appropriate parties.

Qualifications:

Bachelor’s degree or equivalent in engineering or science. Advanced degrees and certifications such as Program Management Professional are a plus
10+ years of combined professional experience in manufacturing, engineering, science & technology or technical operations for a pharma/biotech/device manufacturer.
Minimum of 5 years of global program and/or project management experience is required.
Minimum of 5 years of relevant experience in a drug product fill/finish, device manufacturing or combination product packaging plant environment is required.
Experience with industrialization/qualification of drug product fill/finish, device manufacturing and combination product assembly, labeling and packaging operations is required.
Experience with product transfer from development to operations is required.
Exposure to quality systems, design controls, product labeling, regulatory submission strategy/preparations and product launch/commercial supply are a plus.
Must have above average skills using MS Excel, MS Project, MS PowerPoint, MS Teams and SharePoint. Power BI/Smartsheet and open AI skills are a plus.
Must have the ability to create program charters, execution strategies, milestone tables, Gantt timelines, MS Project schedules, work breakdown structures, RACI matrices, risk registers and material demand and supply plans.
Excellent program and stakeholder management, written/verbal communication, active listening, negotiating, influencing and multi-tasking skills are required. Must be able to effectively facilitate cross-functional resolution of complex scientific, technical, analytical and business issues.
Strong financial skills and business acumen are preferred.
Proficiency in multiple languages is a plus.

24:T71a,

Pay Range: $50-60/hr
*depending on experience

Job Scope: Responsible for case processing and/or QC of clinical trial ICSRs and postmarket case processing from sanctioned countries.
Key Responsibilities:
* Triage, Intake, case entry and QC of ICSRs originating from Biogen sponsored studies or other assigned cases
* Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders
* Perform retrospective quality checks on processed cases
* Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting
* Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management
* Provide investigation details into late regulatory reporting of CT cases

Essential Skills and Qualifications Required:
* Knowledge of Global and local safety regulations
* Excellent written and verbal communication skills
* Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva
* Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
* Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
* Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required

Education and Experience Requirements for Job:
Education : Bachelors degree in science or healthcare related field
Experience : 4+ years experience in pharmacovigilance
(No Value)

25:Td8f,

Target PR Range: 48-58/hr DOE

You will be responsible for sourcing and attracting top R&D Engineering talent to our team. This includes building trusted relationships with hiring managers, developing and maintaining partnerships with HR Business Leaders, and collaborating with various COEs throughout HR. Our Talent Acquisition team takes a consultative approach to recruiting that allows us to use our expertise to find exceptional talent that matches our hiring teams needs.
Develop multiple talent sourcing options for both active and passive candidates, utilize advanced sourcing techniques to identify candidates (e.g., cold calling, job boards, advertising, database and internet searches, networking and referrals) and anticipate organization needs by ensuring an ongoing talent pool.
Lead recruiting activities and portions of strategic talent acquisition projects, processes and programs to fulfill business needs and organizational priorities.
Collaborate with HRBPs and hiring managers to conduct moderately complex offer negotiations and finalize the hiring process.
Craft clear, appropriate and engaging job descriptions that adhere to our employer brand
Provide a consultative approach to hiring managers using data driven recommendations throughout the recruitment and hiring process.
Ensure the highest quality candidate experience by maintaining consistent contact with candidates and dispositioning candidates within set time frames.
Other incidental duties assigned by Leadership

What you’ll need (Required):
Bachelor’s degree in Business, HR, or other related fields and 5+ years of experience in Recruiting/Talent Acquisition
Experience recruiting for engineering roles, including mechanical, electrical, biomedical, manufacturing, reliability, product development, quality, systems, and R&D engineering positions.
Experience recruiting within regulated industries, including medical device, life sciences, biotech, pharma, healthcare, automotive, aerospace, or similar environments.
What else we look for (Preferred):
Prior expertise with Workday or other ATS Systems (e.g., Taleo)
Proven expertise in usage of MS Office Suite
Prior experience in utilizing sourcing skills and systems (e.g., LinkedIn Recruiter, Zoominfo)
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating, consultative and relationship management skills
Proven success adhering to and leading project schedules and managing moderate sections of projects
Substantial knowledge and understanding of policies, procedures, and requirements relevant to talent acquisition
Ability to manage competing priorities in a fast paced environment
Ability to interact professionally with all organizational levels and to build productive internal/external working relationships
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

*CO/NYC candidates might not be considered

26:Te17,

Role Overview
We are seeking an experienced Clinical Trial Manager to provide both strategic leadership and hands-on oversight of early-stage oncology trials, including first-in-human trials. Reporting to the Director of Clinical Operations, you will oversee all aspects of trial management -from start-up through close-out – ensuring trials are delivered on time, on budget, and fully compliant with regulatory and quality standards. As the primary point of contact for cross-functional teams, CROs, vendors, and investigative sites, you will provide strategic guidance, operational oversight, and proactive risk management.
This is a hands-on role in a fast-paced, collaborative environment, offering the opportunity to directly influence the advancement of innovative therapies for patients.

Key Responsibilities

Work with a cross-functional trial teams to manage all aspects of clinical trials ensuring trials are executed on time, on budget, and in compliance with SOPs, ICH/GCP, and regulatory requirements.
Identify and anticipate trial issues or risks that may impact budget, resources, and timelines; plan mitigation strategies with the cross-functional team and escalates as necessary.
Manage outsourced activities with CROs and vendors (e.g., biomarker and specialty labs), including oversight of performance, compliance with ICH/GCP and SOPs, development of oversight plans, and review of monitoring reports to maintain trial quality and compliance.
Manage trial budgets and contracts, including forecasting, invoice review, and expense tracking for accurate reporting.
Monitor trial progress, including participant enrollment, clinical data review, sample collection, and adherence to timelines; provide regular trial status updates and metrics.
Guide trial teams and investigator sites to ensure consistent interpretation and execution of trial protocols and procedures.
Contribute to the development and review of trial-related documents (protocols, ICFs, clinical trial plans, CRFs, manuals, reports, and regulatory documentation).
Ensure Trial Master File (TMF) completeness, accuracy, and inspection readiness, whether managed internally or outsourced.
Participate in the development and refinement of departmental SOPs, processes, and best practices.

Qualifications/Experience

Bachelor’s degree in Life Sciences or related field (advanced degree preferred) with 3+ years of clinical trial management experience.
Proven track record in CRO and vendor management, including oversight of performance, issue resolution, and budget management.
Ability to lead trials independently, ideally within a small, fast-paced team environment.
Working knowledge of data management, biostatistics, and pharmacovigilance.
Global trial experience, including management of multi-country trials from start-up through close-out.
Thorough understanding of FDA regulations and ICH GCP guidelines.
Proficiency with clinical trial systems (EDC, CTMS, TMF) and expertise in trial master file organization and regulatory documentation.
On-site monitoring experience (preferred).
Excellent communication skills, with the ability to collaborate effectively across teams.
Highly organized with strong problem-solving, critical thinking, and prioritization skills.
Ability to travel domestically and internationally, up to 20%.

27:Tcd9,

HM’s Top Needs:

1. Proactive

2. Good communication

3. Proficiency in Microsoft Office (Excel, Word, PowerPoint) with a basic understanding or willingness to learn Systems & Technology (Safety Databases & Tools).

Education Required: at the minimum, a high school diploma

Years’ Experience Required: 0-2

Will the contractor be working 40 hours a week? If not, weekly estimate? The goal is a 40h/week. However, it can be slow at time during the onboarding period

Work Location:

Do they need to be local to any MDT office and if so where? No

Does this person need to be on site? If so, full time or part time? No

Responsibilities may include the following and other duties may be assigned. Provides project or program support to a functional group or business process. Monitors program/project/system status, budgets and timetables. Applies knowledge of and experience in company operations to assist in the development, implementation and administration of program/system guidelines and procedures. Gathers and compiles information for reports. Provides technical support, which may include program/system training, program/system documentation, data extraction, data review, tracking and coding.

OFFICE SUPPORT CAREER STREAM: Individual contributors who provide organizational related support or service (administrative or clerical) for other members within the organization. The majority of time is spent in the delivery of support services or activities, typically under supervision.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works on clerical and administrative assignments that may require application of prior experience. Works under moderate supervision, making minor adjustments to methods and processes.

Organizational Impact: Works to deliver on day-to-day objectives with direct impact on achievement of results for the job area, including moderate scheduling or customer satisfaction implications. Work consists of tasks that are typically routine, with some deviation from standard practice .

Innovation and Complexity: Checks and makes minor adjustments to work methods to solve problems that are routine and typically exist in current work processes and systems . May be required to highlight areas of concerns/problems and puts forth solutions in own job area.

Communication and Influence: Communicates typically with internal contacts within and outside of immediate team. Obtains and provides information requiring some explanation or interpretation .

Leadership and Talent Management: May provide guidance and assistance to new or entry level employees.

Required Knowledge and Experience: Requires full job knowledge of systems and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience.

28:Tcd3,

Top 3 technical skills that are required for the role:

1. Hands-On Experience with Electromechanical Fixtures/Equipment

2. Technical Writing

3. Mechanical Design Experience / CAD

Education Required: Bachelors Degree in Engineering

Years’ Experience Required: 1-4 Years

What product line will this person support? Catheter Manufacturing

Responsibilities may include the following and other duties may be assigned. Evaluates, selects and orders equipment that is most appropriate and cost effective for the manufacture of company products. Oversees the installation, modification, upgrade and maintenance of manufacturing equipment. Maintains current records on equipment manufacturers’ technical notices, upgrades and safety issues. Studies equipment performance and reliability. Establishes programs and solutions for increasing uptime and for equipment problems that affect the manufacturing process. Provides technical support to the manufacturing equipment repair and process engineering organizations. Defines and writes preventative maintenance schedules.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation – while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master’s degree

29:Tca1,

Duties:

* Initiates and completes routine in vitro studies in an independent, efficient, and timely manner, without supervision. Interprets the outcome of those experiments and proposes appropriate follow-up independently; troubleshoots effectively.

* Designs and executes non-routine cell-based in vitro and biochemical assays based on literature analyses; conducts exploratory experiments with minimal supervision.

* Independently applies basic scientific principles, performs literature searches and extracts relevant information from literature and published protocols, attends scientific meetings, and keeps abreast of literature in own field.

* Independently operates and is responsible for lab equipment and maintenance; troubleshoots effectively.

* Proposes new experiments/technologies based on science as well as overall understanding of drug discovery/development process; Demonstrates expertise in field and contributes to training technicians and junior level scientists

* Communicates and defends their own work in the context of team and department goals effectively both orally and in writing; writes protocols, procedures, and technical reports; provides input for scientific reports.

* Reports and treats data with a high level of integrity and ethics. Maintains accurate and up-to-date electronic lab notebooks.

* Complies with applicable regulations, performing all work in a safe and compliant manner; maintaining proper records in accordance with Standard Operating Procedures and policies.

Skills:

* Experience in aseptic mammalian tissue culture techniques and basic molecular biology techniques including nucleic acid extraction, RT-PCR, Western Blot, ELISA, transfection is required. Experimental design, execution, and interpretation in these areas will be required.
* Experience in human pluripotent stem cell culture is desired.
* Proven problem-solving ability and eagerness to learn. Ability to evaluate new technologies and assist in incorporating them into our research.
* Written and verbal communication skills: concise and accurate reporting of technical data and information
* Proficiency with computers and data analysis software such as Microsoft Excel and GraphPad Prism.
* Ability and willingness to work effectively in a highly collaborative environment.

Education:
* Master’s Degree with 3+ years’ experience in related scientific discipline or Bachelor’s Degree with 7+ years’ experience in related scientific discipline or equivalent experience in related field; pharmaceutical, biotechnology or CRO experience is highly desirable; non-PhD applicant required.
* Supplemental technical courses in area of expertise
* Ability to operate laboratory equipment with independence
* Ability to draft technical reports
* Demonstrate written and verbal communication skills
* Concise and accurate reporting of technical data and interpretation thereof
* Proven problem-solving ability
* Able to act for supervisor in his/her absence
* Appropriate level of understanding of applicable regulations

Max PR: 32.71/hr

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