Are you looking for a challenging and fulfilling career? AMS Practice Management connects talented professionals to unique global opportunities with in-demand industries. We can help you take the next step toward reaching your goals and building a career you love.
We are currently seeking dynamic, talented, and experienced professionals to take on innovative assignments with our global clientele.
Principle Regulatory Affairs Specialist – Greater Worcester, MA area
Do you have a passion for women’s health? AMS Practice Management is searching for a Principal Regulatory Affairs Specialist to join a premier medical device organization.
The Principal Regulatory Affairs Specialist is a leader in obtaining and maintaining government approval for medical devices and related materials. This individual is responsible for document preparation, information management, file maintenance, and coordination of tasks across multiple departments. Part of their strategic directive is to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs. The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes. They help review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. In addition, they determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Explain regulations, policies, or procedures
Maintain data in information systems or databases
Ensure compliance with regulations
Advise others on regulatory and compliance matters
Evaluate applicable laws and regulations to determine impact on company activities
Provide technical review of data or reports
Coordinate regulatory documentation activities
Identify and interpret relevant regulatory guidelines
Bachelors in Science, Masters preferred.
7 yrs min exp, med device exp.
Soft ware or electrical background plus.
(510) exp, traditional & special.
Exposure to EU & MDR regs.
Must be seen as an expert in their practice
RAC certified preferred.
Pharmacy Technician – Franklin, TN
AMS Practice Management is in search of a Pharmacy Technician for a premier life sciences client in Franklin, TN. This position is a 2-month contract covering for an employee out on leave.
In this role you will be doing data entry and taking inbound phone calls from nurses or sometimes patients. Under the guidance of registered pharmacist, takes the appropriate actions to ensure the accuracy of patient medication files for enrolled or prospective patients and the accurate fulfillment of prescriptions for enrolled patients.
After receipt of patient authorization, contacts physicians, physician offices, dialysis facilities, and other pharmacies regarding the accuracy and fulfillment of prescriptions for enrolled or prospective patients
Ensures that patient medication profiles are accurate and sent in a timely manner
Ensures that patient prescription needs are met in a timely manner
Speaks with physicians or nurses to verify correct information about a specific prescription
Regularly requests prescriptions and refills from physicians by telephone and/or facsimile. Follows up as necessary to ensure the timely receipt of new prescriptions
Contacts pharmacies to execute patient medication transfers to Rx system
Collaborates with Patient Service Coordinator for all communication with patients regarding prescription issues or other identified anomalies pertaining to prescriptions
Ensures issues are resolved according to procedures escalating the more complex issues to supervisor as necessary
Enters, scans, and links prescription and patient data into Pharmacy Management System
High School Diploma required
Pharmacy Technician Certification required
Registered as a pharmacy technician in the state of Tennessee
1 – 2 years’ related experience.
Retail or Mail Order Pharmacy Experience Preferred – Excellent customer service, communication, organizational and interpersonal skills required
Job Type: Contract
Quality Safety Technician – located in Oregon, OH
AMS Practice Management is in search for a 3rd Shift QS Technician for a premier life sciences client in Oregon, Ohio.
In this role you willconduct quality audits of products assuring company standards are maintained and product integrity is preserved. Consult with management to resolve quality, production, and efficiency problems. Function as an information source to employees when quality issues occur. The schedule for this role is full-time, Wednesday thru Saturday with a pay rate $18.40 per hour.
Under close supervision, acquires job skills and learns company policies and procedures to complete routine tasks. Fulfill duties in accordance with requirements of the QSR regulations, the ISO-9001 standard, Corporate and on-site policies and procedures.
Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
Develop plans by conducting analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
Works on assignments that are routine in nature, determine whether or not communications regarding company equipment are complaints and whether or not complaints might be reportable to the FDA.
Analyze equipment complaints to determine the probability that the reported problem is resolved and, if not, whether additional action to resolve the problem needs to be taken.
Assures laboratory equipment and instrumentation is calibrated and properly maintained
Performs operation, including routine maintenance/cleaning for analytical instruments to ensure proper operation.
Document investigation steps and results.
Communicate with company personnel to investigate complaints.
Follow all policies, guidelines, and Standard Operating Procedures (SOP’s) as required.
May refer to senior staff for assistance with day-to-day problems that may arise.
Escalates issues to supervisor for resolution, as deemed necessary.
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
Assists with various projects as assigned by direct supervisor.
Other duties as assigned.
EXPERIENCE & REQUIRED SKILLS:
Minimum 0 – 1 years of related experience.
Understands basic concepts and principles of dialysis.
Mathematical aptitude required with a good background in algebraic skills and measurement skills.
Basic computer skills with database, spreadsheet, and word-processing programs.
Strong oral and written communication skills.
Strong attention to detail.
Degree in Chemistry, Microbiology,or related field is preferred.
Physical Demands & Working Conditions:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Involves moderately active work involving walking and/or standing for considerable lengths of time. Bending to floor level is required and the employee must be able to routinely lift objects weighing up to 50 lbs as high as 5 ft above floor level.
AMS Practice Management is a premier provider of Talent acquisition and consulting services across the Regulated Industry, Manufacturing, and Information Technology (IT) industries.
We are an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Job Type: Contract
Salary: $18.40 /hour
Immigration Coordinator – Greater Boston area
We are looking for an Immigration Coordinator to support the talent acquisition team within a leading medical device organization. This individual would support the Immigration Specialist primarily with administrative tasks associated with visa sponsorship (H-1B, J-1, TN, etc), permanent resident applications and employer compliance as it relates to the immigration and visa-services function. One would prepare various immigration and visa-related letters (i.e. Client Letters, employment verification letters); review and updatesforeign national employees’ I-9 Forms; and update and maintain the Immigration database and monitor work authorization expiration dates.
Create and accurately maintain files for all work visas, permanent residence cases and other immigration matters and act as a resource for the immigration team.
Coordinate LCA process, including posting and removing LCA notices and printing certified LCAs for signature.
Coordinate recruitment stage in the Green Card process
Assist in visa transfers and extensions
Prepare and maintain H-1B Public Access Files and PERM Audit Files to ensure government compliance.
Responsible for handling all invoicing for services rendered by external Counsel and/or immigration vendors.
Ensure I-9 compliance by monitoring, collecting, and updating foreign national employees’ work authorization documents.
Draft and issue employment verification letters for internal employees, and client letters for contractors upon request
Additional support as needed.
Bachelor’s degree in Business Administration, HR Management or related field preferred.
0-2 years of experience in an operational and/or administrative support role in human resources (prior experience with immigration preferred).
Must be able to maintain strict confidentiality in dealing with all documents, files and communications
Expert skills within the Microsoft Office Suite (Word, PowerPoint, Excel) and experience with Applicant Tracking systems.
Proven organizational, critical thinking and administrative skills with keen attention to detail and strong time-management.
Strong interpersonal and customer service skills.
High attention to detail with strong organizational skills
Excellent written and verbal communication skills
Self-starter with ability to work independently and as a collaborative member of a team
Fast-learner with excellent time-management skill
Training and Development Specialist/Instructional Developer
We are looking for a Training and Development Specialist for our client in the Greater Boston Area.
Do you enjoy developing learning activities and materials? This individual will apply their knowledge of instructional methods and adult learning theory to support the business team in professional development.
Develops evaluation and performance measurement tools to measure post-learning knowledge, retention, and behavioral outcomes. (background in instructional design a plus but not required)
Developed e-learning tutorials for a software-as-a-service application, supporting the deliverable schedule.
Partner with Process Owners and/or Subject Matter Experts on course development build storyboards, recorded voice-overs, and edited course timings maintain content library for Training and Development.
Identifies measurable objectives/outcomes and develops instructional materials (presentations, in-class activities, assessments, e-learning modules, documentation, work instructions, OJTs).
Develop and delivers highly engaging, creative, and effective classroom/online instruction.
Deliver quality customer-service per standards; resolve problems, satisfy requests
Review and revise when applicable annually all education programs (agendas, course outlines, slide presentations, etc.) in conjunction with Process Owner/Subject Matter Expert (SME) to ensure optimal capacity usage.
Provide feedback to Process Owner/SME to improve future offerings.
Service as a back up to LMS Administrator and develop content and site construction layout of T&D information sharing sites and tools (Websites via WordPress, SharePoint Site, Blogs, Newsletter etc).
Ability to support Training Plan Summaries (review and approvals) – write Training Plan Summaries for Training Department when needed
2-5 years of experience in medical devices and/or pharmaceuticals or other regulated environment, training and development or related occupation/experience teacher/instructor (adult level) etc.
Preferred experience in Learning and Development or Training environment required. Dynamic group presentation skills.
Strong background in instructional design, development and delivery.
Knowledge of technology and instructional design for learning tools.
Experience with ComplianceWire or similar learning management systems required.
Strong experience with authoring tools Articulate 360 Storyline or Captivate v9 or v10 required
Video creation experience preferred
Strong interpersonal and communication skills and ability to work effectively with a wide range of customers/business partners with diverse training and development needs.
Impeccable attention to details – First Pass Quality
Ability to manage activity log and manage work to meet deadlines
Strong organizational skills and an ability to prioritize and complete simultaneous projects with minimal supervision
Experience working in a regulated industry and/or in the delivery of GxP or Quality Systems training preferred
Working knowledge of FDA and ISO 13485 Quality Systems Training requirements – preferred
Sr. Level Training Process Manager – Greater Boston Area
We are looking for a Senior Level Training Process Manager for our client in the Greater Boston area.
This individual would lead improvement projects as directed to drive sustainable training and development (T&D) programs including project leadership to ensure cross-functional coordination, communication and execution.
Develop relationships with manufacturing sites, distribution centers and customer/technical service centers, Training and Development business partners to confer and identify their training needs to enhance employees’ skills and the organization’s overall quality of work.
Creating and maintaining Training Matrices ensuring alignment with Curriculum
Manage curriculum with the Learning Management Systems (preferably Compliance Wire); deploying training (understanding of how to create user groups, user group criteria, curriculum, assignments and user accounts),
Accountable for partnering with process owners and subject matter experts to ensure continued applicability, relevance and effectiveness for all training programs and training modules.
Write, design, develop, and deliver training plans that outlines provision of specific training processes, functional area/department needs, training requirements and training objectives along with quality, effective, innovative and engaging training solutions tailored to the needs of learners.
Support Quality Systems Training CAPAs as needed.
Create/revise Training and Development procedures, work instructions and processes and ensure current, compliant to respective regulatory requirements.
Create/revise day-to-day job aides and ensure current to execution steps.
4-5 years of experience in medical devices and/or pharmaceuticals or other regulated environment, training and development or related occupation/experience preferred.
Understanding of training design principles, curriculum development, adult learning theories, and training effectiveness.
Experience with Compliance Wire or similar learning management systems required.
Comprehensive knowledge of training plan, curriculum, and aid design and development.
Strong organizational skills and an ability to prioritize and complete simultaneous projects with minimal supervision.
Experience working independently as well as within cross-functional teams in a collaborative, professional environment.
Demonstrated written and oral communication skills.
Familiar with the FDA and ISO 13485 Quality Systems Training requirements.
Trainer or teaching and facilitation experience preferred.
Broad understanding of US and International regulations including 21 CFR 820, 806, 803, 210, 211 preferred
Talent Acquisition Specialist
Bring your passion to the AMS team.
A technical expert in finding the right person for a job. Must demonstrate a tactical approach to reviewing job descriptions, identifying, sourcing and screening candidates and understanding the client’s culture to make a perfect fit.
Must produce and present many employ-able and qualified candidates for technical positions in the various industries AMS Practice Management serves.
Must be tech-savvy and looking to grow with us.
This position may be remote.
Pharmacovigilance Safety System Operations Specialist – Greater Boston Area
We are in search of a Pharmacovigilance Safety System Operations Specialist for a premier client in Waltham, MA. In this role you will provide day-day support for the Pharmacovigilance(PV) operations using the in-house PV system. Experience with ARISg is highly desirable.
Purpose and Scope:
Utilizes broad knowledge of U.S. Quality Systems requirements in Pharmacovigilance (PV) Software (SW) Safety System area to develop and execute strategies that support our client’s medical device products. Establishes the approach by developing best practices that maximize value for our client by enhancing compliance and reducing cost. Serves as the lead responsible for defining and implementing global Safety system strategies required to effectively monitor and enhance products. Works closely with Renal Therapies Group (RTG) and Global Manufacturing & Quality (GMQ) as necessary to ensure alignment of integration strategies where synergies exist.
Must be on-site.
Bachelor’s Degree required in sciences, engineering, or related technical field; Advanced Degree preferred.
Minimum 3+ years of related experience in the Pharmacovigilance area.
Must possess a unique combination of Safety system specification, installation, maintenance, and management with increasing levels of responsibility management and program management roles.
Has a track record of successful product launches.
Post Market Surveillance Specialist – Greater Boston Area
We are in search of a Post Market Surveillance Specialist for our premier client in Waltham, MA.
In this role you will be responsible for receiving, reviewing, and processing all product inquiries and product complaints for manufactured and distributed products (equipment, drug, and device) as required by applicable regulations, standards, and company policy. Must have previous experience with MDR/ADE reporting and complete follow through with the complaint closure process.
Purpose and Scope:
Responsible for receiving, reviewing, and processing all product inquiries and product complaints for manufactured and distributed products (equipment, drug, and device) as required by applicable regulations, standards, and company policy. Helps provide customer support and serves as a liaison between manufacturing facilities, distribution centers, customer/technical service, and customers/patients regarding product complaints. Partners with Pharmacovigilance resources on any possible adverse event (MDR/ADE) or reportable complaints, as well as with Corporate Quality Engineering on product investigations and trends.
This is not a remote position.
Bachelor’s Degree required, preferably in a healthcare related field. Associate’s Degree may be considered with additional years of relevant experience.
Minimum 2 – 5 years of related experience in the healthcare/device industry or exposure to medical device quality system regulations; understanding of drug/device safety requirements are required; with an Advanced Degree no prior experience may be considered.
Please note we have multiple levels within this job function available depending on prior experience.
Business Development Executive – IT – Greater DC Area
The Business Development Executive is a seasoned sales professional responsible for meeting the company’s growth imperative by providing concierge talent acquisition service to the companies AMS Practice Management serves. This individual will be connecting with IT organizations around the globe that need support in talent acquisition services. At AMS, we pride ourselves on not just placing anyone, we are accountable for the candidates we find, with the commitment that the placement client will find value and convert our individual to a permanent member of their community. We are changing the way contractors are viewed one placement at a time. We are looking for a BDE that cares about the relationships they create, commits to service excellence, and is personally accountable to their business line.
Bachelors degree, Masters preferred
3 years or more of experience in the IT realm; could be as senior level executive or in staffing business as an Account Manager or Technical Recruiter is ideal, but what is more important is drive to succeed and aptitude for the business.