Records Archiving Project Associate Job at Robert Half (Baltimore)

Clinical Research Project Associate

Clinical Research Project Associate - Monday - Friday (7:30 AM- 4:00 PM) - Great...

Location

United States , Lenexa

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Associates or BS degree, or equivalent experience with HS diploma/GED
Experience in an administrative capacity managing documentation and multiple systems, preferred
Proficiency in computerized information systems and standard application software, including MS Office
Strong skills in MS Word, PowerPoint, Excel, and Outlook, with experience in maintaining Excel trackers and building PowerPoint slides

Job Responsibility

Organize classify, index, file, retrieve and store records and documents in the document storage filing system
Overseeing internal and client project reporting, ensuring accuracy in reports for project status and financial tracking, along with system updates and queries
Ensure that material submitted for archiving corresponds to that described in chain of custody documentation
Maintain the documentation storage to ensure that it is organized and has a clear path to entry and exit and remains in compliance with SOPs
Support the project manager to facilitate sponsor audits by performing review of index file and providing notification of missing documents
Maintain the templates and forms used in support of document storage to ensure that they are current and readily accessible to project teams
Preparing and maintaining study files, ensuring compliance with filing/naming guidelines in the electronic trial master file, and tracking document status

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Senior Manager, Commercial Training

We are looking to bring on an exceptional training professional who can contribu...

Location

United States , Morristown

Salary:

135000.00 - 175000.00 USD / Year

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor's Degree required
A minimum of 3 years of overall pharmaceutical/biotechnology experience
Prior pharmaceutical/biotechnology sales and sales training experience required
corporate/home office training experience highly preferred
Launch experience a plus
Ability to work onsite in the Morristown, NJ office on a hybrid basis (minimum 3 days per week)
Ability to travel up to 20% (to National and/or POA meetings as required as well as field rides with representatives), which may include overnight and/or weekend travel
Knowledge of multiple physician types, including hepatologists and gastroenterologists (specific knowledge of liver or other metabolic diseases is highly preferred)
Proven track record for delivering strong, consistent results in a pharmaceutical sales organization and being an effective, results-oriented project leader
Must possess a strong ability to manage multiple projects across functional areas, and work independently when appropriate, in teams and as a sub-team lead

Job Responsibility

Identify commercial training and development needs
support the US Commercial team (products/technical/skills) needs analysis
develop and implement training and development programs across the field functions
Lead the development of high quality effective sales training materials including leaders' guides, and participant guides, while ensuring a blended learning approach, e.g., virtual, regional, face-to-face, national meetings, pull through training
Provide input on behalf of the Commercial Training function to the development of new marketing materials and messages
Deliver initial training, providing new employees with the requisite level of disease and product knowledge and skills
this includes development, coordination and certification
Provide ongoing training, support and coaching to the customer-facing teams in line with the brand strategy
design and deliver training and development solutions focused on developing competencies
Ensure that best practices in account management (Selling Skills model) and sales effectiveness are embedded in the sales process

What we offer

401(k) plan with company match
Rewards and recognition program
Health care benefits (medical, prescription drugs, dental, and vision insurance)
Short and long-term disability coverage provided
Plan coverage for domestic partners
Paid parental leave benefits and adoption assistance
Tuition reimbursement assistance
A generous Paid Time Off program that includes 20 vacation days, 11 holidays, 4 personal days, and 2 volunteer days per calendar year
Numerous well-being and work/life programs

Fulltime

New

Site Contract Associate Ii

Parexel are looking for a Site Contract Associate I to join our Site Contracts t...

Location

Serbia; Romania

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Fluent command of German and English (written and oral) is required in addition to the local language
Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint
Some experience of working on contracts/agreements
Strong negotiation, diplomacy, and excellent organizational skills with demonstrated experience handling multiple projects
Excellent interpersonal, verbal and written communication skills
Strong problem-solving skills
Ability to successfully work in a “virtual” team environment
Must have strong analytical skills with the ability to create or interpret legal language and budgets
Maintain grace under pressure while displaying a high level of professionalism
Align internal and external resources to achieve objectives

Job Responsibility

Draft, review and negotiate all site agreements including but not limited to clinical study agreements, service agreements, team member agreements and other types of related documents like letters, notices, etc.
Provide context to comments received from sites in light of local legal and business framework, common practices, and past negotiation experience for the purpose of further review up the decisioning chain
Apply and scrutinize site contract and related documents and their revisions against negotiation and budget parameters (as applicable)
Ensure final documents comply with applicable laws, regulations, and guidelines, including ICH – GCP
Ensure the best interest of both clients and Parexel are met
Serves as key communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
Manage the contract execution process, including obtaining required signatures and ensuring timely execution of the document by all parties
Follow record maintenance and archival guidelines to ensure they are met
Develop and maintain positive relationships with clinical trial sites
Develop and maintain a thorough understanding of the clinical trial protocol, budget, and timelines to ensure that contract terms align with the overall trial goals and objectives

Fulltime

Logistics Support Specialist

At Boeing, we innovate and collaborate to make the world a better place. We’re c...

Location

Australia , Brisbane

Salary:

Not provided

Boeing

Expiration Date

Until further notice

Requirements

Cert IV or equivalent in a discipline relating to product support, and typically 9 or more years work experience, or an equivalent combination of technical education and experience.
Demonstrated ability to analyse and interpret aerospace systems and associated technical information to develop high quality, compliant LSA products.
Extensive experience with definition, set-to-work and operation of Product Support and life-cycle analysis-related business systems.
Expertise and ability to collect, organize, synthesize, and analyse data
summarize findings
develop conclusions and recommendations from appropriate data sources at the department level.
Complete knowledge of processes and tools to maintain, archive, and retrieve digital files. Complete ability in constructing/building and providing reports and presentation material as needed for assigned projects.
Knowledge of research tools (e.g., search engines, library databases), methods (e.g., search parameters), and appropriate resources (e.g., external experts) to gather needed data.

Job Responsibility

Develop and update core product line, and project/customer-specific LSA data and document products, in accordance with Insitu Pacific Quality Management System (IPQMS) processes, and customer requirements.
Update LSA records, data and documented products based on internal/external reviews, source data changes, equipment modifications, and customer improvement requests, and resolve source data gaps and inconsistencies with originator.
Support customer verification reviews and take corrective action based on outcome.
Contribute to plans and estimates of proposed changes to the LSA products and services.
Monitor performance to project plan and budget and coordinate actions to meet project objectives. Participate in or conduct customer technical and program reviews. Resolve identified discrepancies and initiate corrective actions.

What we offer

Generous study assistance and education options
Salary packaging and Career Development support
Health and wellbeing benefits including annual flu vaccinations and access to an Employee Assistance Program
Access to discounts for health insurance, travel and accommodation
Paid study leave, paid parental leave and Defence Reservist leave
Formal reward and recognition program

Fulltime

Senior Associate Supply Chain Compliance Management

In this vital role you will be part of the External Planning and Delivery Team, ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Any degree and 5-9 years' supply chain experience in GMP-regulated pharmaceutical / biotechnology industry, or related business fields
at least 2 years' experience working in teams, projects, and programs (this experience may run concurrently with the required GMP-regulated experience referenced above)
Experience in Supply Chain, External Manufacturing, or Quality within a GMP environment
Strong knowledge of GMP documentation practices and quality systems
Experience managing SOPs and document control systems
Familiarity with document management systems and training compliance tracking
Experience supporting audits or regulatory inspections
Strong organizational and project management skills
Excellent written and verbal communication skills
Ability to operate independently while partnering cross-functionally

Job Responsibility

Own and manage all team SOPs (GMP and non-GMP), work instructions, and guiding documents
Lead periodic SOP reviews, revisions, and lifecycle management in alignment with Amgen quality systems
Ensure alignment of team procedures with global policies, regulatory requirements, and CMO oversight standards
Coordinate cross-functional reviews and approvals of procedural documents
Maintain document control and ensure inspection readiness at all times
Monitor and report performance metrics (e.g., cycle time, aging, on-time closure)
escalate overdue items
Monitor and report (SOP, training, regulatory commitments, deviations and change management) trending and provide leadership with insights and action plans for improvement
Own and track all team training requirements (GMP and non-GMP)
Manage training completion, driving closure of overdue items

Fulltime

Associate Quality Control (Analytical)

Amgen is one of the world's leading independent biotechnology companies. For ove...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Chemistry, Biochemistry, Life Science or related technological field and 2 years of directly related experience OR Associate's Degree in Chemistry, Biochemistry, Life Science or related technological field and 4 years of directly related experience OR High School Diploma in Chemistry, Biochemistry, Life Science or related technological field / GED and 6 years of directly related experience
1-2 years of relevant laboratory experience in the commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred
Knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods
Experience with Quality Control testing and laboratory operations for common testing methods and equipment (e.g. including but not limited to UPLC, HPLC, LC-MS, GC-HS, LOD, Auto-titration, KF, Optical Rotation, wet chemistry, FT-IR, pH, conductivity, TOC, Potency, ELISA, Capillary Electrophoresis, DNA Testing)
Good communication skills (technical writing and verbal communication/ presentation)
Interact effectively with variety of communication and working styles and ability to work well in teams
Ability to manage multiple simultaneous activities in a rapidly changing environment
Problem solving skills and troubleshooting skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

Job Responsibility

Perform analytical testing of in-process control, drug substance intermediate, final release, stability and plant cleaning samples in a GMP pharmaceutical environment
Support laboratory operations including but not limited to equipment qualification, calibration, cleaning and maintenance, reagent/ buffer preparation
Responsible for maintenance of chemicals and consumables inventory
Ensure proper handling, storage, disposal of all chemicals used in the lab
Responsible for laboratory housekeeping and document archival duties
Participate in laboratory investigations and assist in timely closure of investigations, CAPAs and deviations
Participate in method verification and method validation/ transfer for new product introduction (when required)
Perform review of laboratory data/ records
Assist in SOP/ protocol/ report writing
Assist in periodic review of laboratory procedures and risk assessment

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Coordinator, Curricular Programs, MBA Registrar Services

Are you a higher ed professional looking to utilize and contribute your program ...

Location

United States , Boston

Salary:

Not provided

HBS

Expiration Date

Until further notice

Requirements

High School Diploma, GED, or equivalent is required
5+ years of experience in administrative support role(s) is required
Education beyond high school may count toward experience
Microsoft Office (Word, Excel, PowerPoint, and Outlook) experience is a must
Excellent communication and organizational skills
Outstanding customer service focus
Strong attention to detail
Discretion, judgment, and an ability to work with sensitive information in a confidential manner
Strong command of Microsoft Office programs especially Excel

Job Responsibility

Oversee ongoing updates to the Student Information System database (SIS) to ensure accuracy in date, start time, end time and location details as well as faculty/staff access, student enrollment records and grade reporting
Assist with creation of all courses in SIS
manage lesson and enrollment loads
Liaise with Operations on classroom spaces for Elective Curriculum (EC) use
Participate in the Required Curriculum (RC) sectioning and discussion group formation process
Oversee capacity limits of EC course sections through course selection and cross registration processes, including work with HBS Doctoral Program and MBA Tech Fellows
Manage Independent Projects (IP) posting site
respond to companies, organizations, alums and faculty who submit project ideas, publish for students and archive at term close
Oversee use of online registration tool for Independent Projects (IP) and field questions from students and potential supervisors
Data analysis and reporting on EC courses to support faculty and MBA program leadership

What we offer

Generous paid time off including parental leave
Medical, dental, and vision health insurance coverage starting on day one
Retirement plans with university contributions
Wellbeing and mental health resources
Support for families and caregivers
Professional development opportunities including tuition assistance and reimbursement
Commuter benefits, discounts and campus perks

Fulltime

Sr Associate QA

The International & Distribution Quality (IDQ) team supports products to and in ...

Location

China , Shanghai

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in pharmacy or related majors
Above 3-5 years experience in a pharmaceutical company
preferred to have quality function experience in a distribution company, manufacturing site and/or auditing function
Has knowledge of local regulations related to Good Distribution/Supply Practice (GDP/GSP) and Good Manufacturing Practices (GMP)
Good written and spoken English and Mandarin
Strong project and time management skills
ability to plan tasks and timetable in advance
Patient, be able to work independently and under pressure
Strong initiative, mature, attentive to details and a good team player
Problem solving

Job Responsibility

Support activities to maintain the quality system and execute tasks in compliance with Amgen’s Quality Management System, GDP/GMP requirements and any local applicable regulations
Completes required assigned training to permit the execution of required tasks
Conduct GSP remote and on-site Due diligence visit and/or Inspection, may extended to GMP related
Alerts any quality, compliance, supply and safety risks
Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
Conduct Product complaint outbound work per the guidelines, such as reconciliation of Product complaint samples
Provide quality guidance for commercial programs including patient support programs and Product Complaint training
Consolidation of information on complaint sample returns and replacements. Handling of complaint‑related OBT activities. Tracking and follow‑up of complaint return samples
Updating and maintenance of complaint training materials. Continuous optimization of complaint‑related communication and responses in collaboration with cross‑functional teams across Amgen China
Provide support for supplier onboarding. Submission of payment requests for reagents

Fulltime

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Records Archiving Project Associate

Job Description

Job Responsibility

Requirements

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