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发帖数: 1329 | 1 From: HR Communications
Sent: Friday, September 20, 2013 11:10 AM
To: +Billerica-All Users; +Hackensack-All Users; +Perceptive-East Windsor; +
Perceptive-Wayne; +Waltham-All Users
Subject: Featured Job Openings for Northeast [on behalf of Rose Barsumian]
Featured Job Openings for Northeast
Do you know the perfect candidate for a job at PAREXEL?
These Featured Jobs highlight open positions in your local area and there
may be others so please check the Employee Referral website for a full
listing of job opportunities. Think about friends, family and former
colleagues that are a good fit for these and other open positions at PAREXEL
. Refer them through the Employee Referral website and fabulous prizes
could be yours!
Featured Jobs
Detailed job descriptions can be found on the Employee Referral website.
Senior Quality Manager, Process QM – Decentralized
• Provide leadership and guidance to Operations staff in process
application and adherence, and for identifying areas for efficiency gains
and improvement within the function
• Support and/or lead the development and implementation of new
systems and tools for the Functional Groups (FG); direct Process Quality
Management staff in this role
• Oversee development and delivery of training; support functional
staff in the development and implementation of operational QC processes,
quality gates and quality metrics
Senior Quality Specialist, Process QM – Billerica, MA
• Provide support to Operations staff in the implementation of and
adherence to processes, controlled documents, tools and templates to enhance
quality of deliverables
• Identify process gaps and/or improvement opportunities; process
authoring and review; support process reengineering; develop related
training materials and/or deliver training
• Provide GCP and process expertise to designated operational group
(s); support for identification, management and prevention of project
quality issues; provide audit and inspection support and oversee the
collection and reporting of project quality metrics
Project Financial Analyst II – Billerica, MA
• Develop actual/forecasts versus the budget for professional fees
and pass through expenses (3rd party vendor costs, investigator fees, travel
expenses, etc.); review and discuss with project team
• Complete month end responsibilities including revenue recognition
and forecasts, variance analysis, SOX compliance tasks, PERFORM updates,
profitability analysis, etc.
• Review variances identified by SOX controls and escalate to
Project Leader; provide financial analysis of revenues & costs (actual &
forecast) and recommend actions to address variances
• Develop and distribute consolidated worldwide monthly reports
detailing the financial status of assigned projects and/or programs
Compliance Manager, Regulatory Research Compliance – Billerica, MA
• Experience with GCP compliance and other regulations and laws,
PAREXEL procedures and processes to host and coordinate audits and provide
expert advice to internal and external clients
• Effectively lead, manage, develop and implement assigned projects
• Provide leadership, management support and guidance to the team
• Exhibit a high degree of flexibility and initiative, demonstrate
the ability to follow up on multiple tasks and projects and possess the
ability to handle confidential information diplomatically
Portfolio Director, Strategic Accounts – Phase II/III – Decentralized
• Oversee all aspects of ongoing clinical trials within a
designated Regional/Client Grouping; maintain and cultivate client
relationships for future business development opportunities
• Lead PAREXEL team in the eyes of the customer and ensure client
satisfaction
• Minimum undergrad degree in a science/health related field
required, advanced degree preferred; (MS, MBA, PhD); extensive Project
Management experience of domestic and international studies
• Strong client interaction and financial knowledge, conflict
resolution and risk management and prior CRO experience preferred
Consultant, Resource Management – Waltham, MA
• Engage with business leaders to influence resource related
decisions and challenge assumptions
• Assign team members for proposals, bid defense meetings and
awarded projects
• Possess a decisive confidence to work with all levels of
management and functional areas
• Excellent analytical skills along with extensive experience using
Excel and PowerPoint
• Bachelor’s Degree required; MBA a plus
Project Leader/Senior Project Leader – Peri-Approval (PACE) –
Decentralized
• Provide leadership to the cross functional project team to ensure
performance meets and/or exceeds expectations for domestic or international
projects
• Lead, manage and oversee large and complex clinical studies or
clinical study programs
• Lead project operational components, including forecasting,
financial measurements and quality parameters; direct and participate in
capabilities presentations, bid defenses, and client meetings
• Late phase experience with large scale post-marketing EAP,
registry and remote monitoring trials preferred
Project Leader/Senior Project Leader –Phase II/III – Decentralized
• Provide leadership to the cross functional project team to ensure
performance meets and/or exceeds expectations for domestic or international
projects
• Lead, manage and oversee large and complex clinical studies or
clinical study programs
• Lead project operational components, including forecasting,
financial measurements and quality parameters; direct and participate in
capabilities presentations, bid defenses, and client meetings
• Global Phase II/III study experience
Principal Biostatistician – Billerica, MA
• Work independently on clinical trial projects; act as a
statistical expert; provide broad support, including trial design, protocol
and CRF development on specific studies
• Lead production and quality control of randomization, analysis
plans, statistical reports,
statistical sections of integrated clinical reports, and other process
supporting documents
• Understand regulatory requirements related to the specific
therapeutic areas and the implications for statistical processing and
analysis; PhD in Statistics or related discipline with 3+years’ experience
or MS in Statistics or related discipline with 5+ years’ experience
Medical Operations Leader, Drug Safety – Billerica, MA
• Utilize your strengths in strategy and planning, client
relationships and operational execution
• Provide direction for all Medical Services and Pharmacovigilance
projects including Serious Adverse Event (SAE) management, medical
monitoring, clinical event data monitoring committees and clinical and post-
marketing related projects and activities
• Work with clinical trial safety management, safety databases,
regulatory reporting of serious adverse events, medical monitoring and
project management
• Lead, mentor and support your team to deliver client projects
while improving quality and satisfaction
Director, Biostatistics – Decentralized
• Responsible for strategic advice and operational execution in
drug/device/diagnostic developments up to submissions and approvals, as well
as successful reimbursement applications
• Thorough understanding of the drug/device/diagnostic development
process
• Proven expertise in optimizing trial design, development programs
, submission strategies and successful regulatory interactions
• 15 years’ experience in the pharmaceutical industry, with
therapeutic area knowledge; demonstration of successful direct interactions
with relevant regulatory agencies like FDA/EMA/PMDA/SFDA
Senior Requirements Analyst – Billerica, MA
• Facilitate communication between stakeholders; document
agreements and open issues in the various documents such as Application
Requirements and Data Transfer Specifications
• Represent requirements using alternative views, such as SDTM,
annotated CRFs and Use Cases
• Knowledge of the clinical data lifecycle, industry tools to
support data flow, and the use of CDISC Standards (SDTM, CDASH, ADaM)
• 2+ years’ experience working with CDISC standards and standards
specifications; 4+ years’ experience in gathering requirements from
stakeholders
Associate Live Study Manager – Decentralized – California, New Jersey &
Illinois
• Participate in study design team meetings with the Project
Manager, Requirements Analyst
• Provide support to the Project Manager on study related duties
during pre-go-live activities
• Responsible for live study support activities including client
contact
• Excellent customer service and computer skills, high attention to
detail and proficiency in MS Office
Data Analyst/Data Modeler – Billerica, MA
• Act as a liaison between project management, business analysts
and architects/delivery teams
• Translate business requirements and business intelligence
reporting requirements into functional or technical specifications; perform
data profiling to ensure data requirements in the project deliverables
• Understand business process and data modeling concepts including:
Data Flow Diagrams, Process Models, ER diagrams, Dimensional Data Models,
Context Models and Use Case Scenarios
• Knowledge of data warehousing or business intelligence
methodologies, especially Kimball Dimensional Modeling; experience with Data
Modeling tools such as Sparx Enterprise Architect
Senior Systems Engineer – Billerica, MA
• Lead complex systems projects both regionally and globally
• Provide consultation and direction to IT Management and
Infrastructure teams in multiple disciplines
• Experience in Virtualization VMWARE and Hyper-v, Cisco UCS and
Netapp storage
• Experience in design, implementation and management of Enterprise
Infrastructures and Systems
Associate Java Developer – Billerica, MA
• Develop enterprise services to integrate complex applications per
SOA standards, according to requirements, following an Agile Methodology
and the PAREXEL Software Development Lifecycle
• Perform and document unit testing of all code managed in a source
code controlled environment
• Bachelor’s Degree or higher in Computer Science; 1-3 years’
hands-on development experience
• Java programming experience with Java/J2EE based Internet
applications that include a combination of Java and J2EE integration
technologies like SOAP, JMS, Web Services, JNDI, JDBC
Senior Manager, Portfolio & Project Leadership – Billerica, MA
• 6 years’ pharmaceutical, clinical research or consulting
industry experience at a management or expert level
• Demonstrated ability to motivate others
• Experience implementing process and operational improvements
• Prior line management experience preferred
Proposal Coordinator – Clinical Logistics – Billerica, MA or Durham, NC
• Responsible for the coordination of Operations, Portfolio
Operations Leadership, Legal, Business Development and Finance to prepare,
review and negotiate proposals and contracts
• 5+ years’ experience in healthcare, clinical research, project
management or contract research organization
• Master’s degree or equivalent in a related field of
specialization, with an advanced degree desirable or relevant work
experience/degree
Senior Depot Coordinator/Supervisor – Billerica, MA
• Liaise on a daily basis with the Senior Clinical Supply
Coordinator; oversee depot activities regarding material flow, capacity and
storage requirements; provide guidance to Depot Coordinators and Depot
Technicians; implement and maintain production schedules and align resources
for day to day work
• Knowledge of the cGXP guidance, or willingness for education in
cGXP regulations
• Warehouse experience in clinical logistics or related field
within the biopharmaceutical industry
• Multinational work experience with Good Clinical Practice and
Good Manufacturing Practice
Clinical Logistics Leader – Billerica, MA
• Lead the Clinical Logistics Services teams by combining clinical
logistics experience with insight into client pressures and an ability to
develop the right solution for the client
• Educated to B.A./B.S. or Master’s degree or equivalent (e.g.
PharmD) in biology, pharmacy or other health-related discipline,
international trade, business administration or logistics
• 7 years’ pharmaceutical, clinical research or consulting
industry experience
• Experience implementing process and operational improvements;
direct management experience
Manager, Regulatory Affairs – Decentralized
• Assist the team with the identification and review of regulatory
issues which impact Liquent’s customer’s standards, processes, and
solutions, related to management of regulatory information
• Minimum BS/BA, preferably in a science-related field and 5 years
’ Life Sciences experience in defining requirements for and/or
implementation of regulatory solutions; travel up to 50%
• Understanding of regulatory processes from early development
through product retirement
• Experience filing various types of submissions (IND, CTD, NDA,
NDS, MAA, Annual Reports, labeling changes, etc.) and producing paper and
electronic output for delivery to regulatory agencies
Upon the hire of a candidate referred to PAREXEL via the Employee Referral
website, the referring employee is automatically entered into both monthly
and quarterly drawings. Four prize choices are available to monthly winners
– 16 Gig iPod Nano, Digital Picture Frame, Digital Camcorder and Portable
GPS – and the quarterly drawing is valued at up to $2500 USD!
Additionally, after 90 days of the referred candidate’s employment with
PAREXEL, the referring employee is eligible to receive an Employee Referral
Bonus. These payments are based on the hired employee’s position and
geographic location and can be found on the Bonus Awards page of the
referral website.
The employee referral program is an important hiring tool and an essential
element to the company’s success – attracting talented candidates to
maintain a strong workforce. As the company continues to grow, please
consider participating in the recruitment process by referring your network
of experienced contacts to fill these Featured Jobs or any open positions.
For more information on this program or to refer a friend visit the Employee
Referral website today!
Kind regards,
Rose Barsumian
Talent Acquisition Assistant |
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