kParalegal

Envivo Pharmaceuticals ( www.envivopharma.com)

The Paralegal will have responsibility for managing corporate, contractual and IP matters relating to multiple projects and products in EnVivo’s pipeline. The Paralegal will develop and update templates, develop and present training programs, perform internet research, and provide support for internal client contracting needs. The Paralegal will also create and maintain contracts and patent databases, both electronic and paper-based. The Paralegal will report to the VP, General Counsel.

Position responsibilities:

•        Drafts, reviews and/or proofreads various corporate agreements and identifies issues for review and decision by supervising attorney.

• Creates, maintains and updates department filing systems (contracts, corporate and patent files).

• Represents Legal Department internally to clients. Communicates advice of the Legal Department to other departments, including research and development. Assists General Counsel in managing legal risks to the corporation.

• Comprehends, adheres to, maintains and communicates department policies, procedures and processes.

• Keeps abreast of changes in laws that affect agreements as well as specific client areas of responsibility.

• Retrieves hard copy agreements from files. Makes copies, scans documents and performs other various light administrative duties as required.

Desired Skills and Experience:

- Bachelor’s degree

- Minimum of 5 years’ paralegal experience, ideally in a biotech company

- Sharp attention to detail, highly organized, task-oriented with excellent sense of prioritization skills, and able to work on matters with minimal direction or ongoing supervision.

- Highly proficient with Microsoft Office applications, including Word, Excel, PowerPoint and Outlook

- Ability to think critically and communicate professionally, clearly and concisely both verbally and in writing

- Ability to work in a fast-paced, dynamic small company

- Responsive to clients

- Motivation and perseverance in every activity

- Ability to draft concise and effective contractual documents

- Familiarity with federal and state laws regarding relevant issues  

- Awareness of industry trends and marketplace changes

- Ability to work independently and to interface with all internal departments

Metamark Genetics is an oncology company focused on the discovery and development of prognostic tests addressing the critical unmet needs in cancer progression and metastasis. We are looking for a Research Associate/Senior Research Associate to join our Prognostic Test Development Group. The candidate will become part of a R&D team developing a novel quantitative multiplex immunofluorescence-based test for prediction of Prostate Cancer progression.

Qualified candidate will have a BS/M.S in relevant scientific discipline (biology, biochemistry, molecular biology, immunology, etc.) with 3+ years of experience in academic laboratory or biotech industry. We are looking for individuals highly experienced with the following:

• Strong background in cancer biology and pathology – required
• Immunofluorescence/Immunohistochemistry/immunocytochemistry      – required
• Immunofluorescence microscopy and analysis -required
• General molecular biology laboratory skills (Western Blotting, PCR, cloning, plasmid purification, sequencing and sequencing analysis) - required
• Mammalian tissue culture (cell line propagation, development of engineered cell lines) through transfections and/or viral transduction) -preferred
• Utilization of in vivo animal model system in target validation (xenograft, knock-out, transgenic) -preferred

Positive, dedicated, diligent, interactive personality with good communication skills is required. The candidate will be an integral part of a research and development team and also have opportunities to work independently.

*Local candidates only, no recruiters, no phone calls

* Metamark Genetics will not offer visa sponsorship for this opportunity

Please submit resume by email to jobs@metamarkgenetics.com

RESPONSIBILITIES
Monitor manufacturing operation for compliance to Standard Operating Procedures (SOP's) and batch records. In addition, ensures that all products are manufactured accurately. Monitor facilities operations to assure compliance with current Good Manufacturing Practices (cGMP's) and written procedures. Perform internal audits of all Quality Systems within the facilities. Perform external audits of Vendors of raw materials/components/contract manufacturers and labs Working knowledge of cGMP's and FDA Guidance Documents. Investigate deviations Evaluate cGMP documentation for accuracy/revisions

REQUIREMENTS
Bachelors degree preferred and 2+ years experience working in Quality Assurance within a cGMP enviornment.  Knowledge of manufacturing operations Good technical writing and computer skills.

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

Lifeguard. Traffic Manager for growing, independent agency specializing in rare disease marketing.

 Job Description:

What you should know:

Employment at Cambridge Biomarketing means more than just managing a schedule. You will be working for a full-service, independent agency that is growing and determined to do it right. You will work closely with all teams to deliver best-in-class projects for our clients. Your deep understanding of process will be idolized. Sound like your kind of place? Read on.

Who we are looking for:

• Cambridge Biomarketing is seeking a strong Traffic Manager to join their growing team to manage a wide range of projects.
• This dynamic position will involve:
  • Drive projects to success
  • Decide, negotiate and enforce Agency deadlines and client deliverables
  • Schedule and Status Reports/Meetings creation and management
  • Relationship management
  • Risk management (schedule, team hours and resources)
  • Provide day-to-day internal project management and guidance in accordance with an established workflow process, to meet deadlines and client deliverables for all print projects.
  • Assess, organize and execute multiple projects accurately, thoroughly, and efficiently.
  • Enforce our process which provides solid guidelines for Agency
  • Communication:
    • Keeps all departments informed of deadlines and changes; distributes information quickly and effectively
    • Understands time needed for each department/team member to complete assigned work and communicates accordingly
    • Understand impact of changes to schedule and coordinates work to stay on schedule
    • Keeps team members informed of deadlines and how changes impact their work

Desired Skills & Experience

Base Requirements

• 5+ years of experience (healthcare/pharma exp. a plus)
• Comfort level working with all Agency departments in a fast-paced, deadline-driven environment
• Demonstrated ability to lead project teams from concept to launch
• Self-motivated, grace under pressure, and able to motivate other team members
• Ability to clearly set and manage expectations internally
• Experience developing and managing schedules and budgets for large and small projects
• Ability to manage both internal and freelance resources

Additional skills

• Willingness to adapt to new process as needed

Lifeguard. Digital Project Manager for growing, independent agency specializing in rare disease marketing.

 Job Description

What you should know:

Employment at Cambridge Biomarketing means more than just managing a schedule. You will be working for a full-service, independent agency that is growing digitally and determined to do it right. You will work closely with all teams to deliver best-in-class digital solutions for our clients. Your masterful orchestration techniques will be essential to our success.  Your deep understanding of technology and process will be idolized. Sound like your kind of place? Read on.

Who we are looking for:

• Cambridge Biomarketing is seeking a strong Digital Project Manager to join their growing digital team to manage a wide range of digital projects.
• This dynamic position will involve:
  • Drive projects to success
  • Schedule creation and management
  • Relationship management
  • Risk management (schedule, team hours and resources)
  • Working with integrated digital team
  • Sound understanding of the Digital Agency model

Desired Skills & Experience

Base Requirements

• 5+ years of experience (healthcare/pharma exp. a plus)
• Understanding of web development technologies
• Comfort level working with digital team in a fast-paced, deadline-driven environment
• Demonstrated ability to lead project teams from concept to launch
• Self-motivated, grace under pressure, and able to motivate other team members
• Ability to clearly set and manage expectations internally and externally
• Experience developing and managing schedules and budgets for large and small projects
• Ability to manage both internal and freelance resources

Additional skills

• Willingness to adapt new technologies and process as needed

Join a financially stable, profitable and rapidly growing medical device company that provides best-in-class product and a dynamic workplace environment with experienced and motivated professionals.

• Ensure that the quality system is implemented and maintained in accordance with the FDA, QSR Part 820, ISO 9001, ISO 13485, and all other applicable regulatory requirements.
• Establish the methods for and oversees all test activities, including incoming inspection, in-process inspection, and final quality testing.
• Directly support requirements traceability activities.
• Directly support all hazard analysis and risk management activities.
• Perform internal audits of quality controls.
• Work on and lead teams to implement corrective and preventive actions, including root cause analysis of problems, planning of activities to fix problems, creating procedures and work instructions to implement changes to quality system, and verifying the effectiveness of such changes.
• Collects, analyzes, and reports information to provide monitoring of quality system performance.
• Complete and assist with 510(k) submissions, PMA Supplements, design dossiers, and technical files.
• Correspond with international regulatory agencies and maintain all licenses worldwide.
• Participate in independent audits and perform internal audits as needed.
• Evaluate the regulatory pathway for product modifications in adherence to FDA and international regulations.
• Evaluate product labeling, brochures, and Directions for Use per current worldwide standards.

Requirements

•              Bachelor’s degree

•              5 to 10 years related experience in the medical device industry

•              Excellent verbal and written communication skills

•              Ability to multi-task in a dynamic, fast paced environment

•         Ability to travel for audits (less than 5% of time)

Compensation and Benefits

•              Competitive salary based on experience and position

•              Blue Cross Blue Shield PPO health insurance.  Company pays 100% of monthly premium

•              Italian chef prepares complimentary lunch daily for the entire staff

•              Free parking available at facility

•              Up to 25% annual contribution to profit sharing plan

•              Over four weeks of paid time off including personal time and national 

•         Guardian Life and Long Term Disability Insurance.  Company pays 100% of monthly premium.

•              Optional Flexible Spending Account (FSA) 

Please submit resume to: kprovost@biomedicalsearch.com

Our client is a globally respected consulting company serving medical device clients in the areas of areas of regulatory/clinical consulting, product development, strategic planning, operational staffing and venture financing.  

Responsibilities

The position is client-facing and can require up to 50% travel. Ideal candidates must be able to work independently as well as under direct supervision and with others.  Key responsibilities are:

• Manages research by identifying potential investigators, conducting pre-trial site visits, training site staff; monitoring trial product accountability; studying clinical requirements; evaluating resources.

• Organizes information by analyzing data; comparing information discovered to information specifications; preparing correspondence.

• Prepares research reports by confirming Case Report Form (CRF) and Severe Adverse Event (SAE) reporting; identifying protocol deviations; summarizing information; citing source documentation while adhering to internal procedures and federal guidelines.

Requirements

• Bachelor’s degree in a scientific, engineering or mathematical discipline 

• Exceptional analytical, problem-solving and research skills 
• Excellent spoken and written communication skills
• Strong Microsoft Office familiarity (Word, Excel, PowerPoint, Outlook)
• Statistical Analysis Software (SAS) Proficiency
• Basic statistical and mathematical knowledge
• Ability to travel up to 50%

Please submit resume to: mrutledge@biomedicalsearch.com

Summary of Responsibilities

Reporting to the VP Manufacturing, the Senior Analytical Chemist is responsible for the generation, review, training and documentation of all analytical testing methods employed in the manufacture of new Radiopharmaceuticals at Molecular Insight in compliance with current Good Manufacture Practices. 

An advanced scientific degree is required in pharmacy or chemistry, with experience in the testing and release of pharmaceutical or radiochemical agents for clinical use. 

Specific Responsibilities

• Hands on development of new test methods and direct validation efforts
• Technical review of reports and documents submitted to QA and to RA for regulatory submissions
• Manage analytical instrumentation laboratory and maintenance schedules
  • Monitor adherence to SOPs and oversee version control and compliance
  • Monitor Radiation Safety compliance for handling and testing radioactive materials 

Summary of Responsibilities

Reporting to the VP Manufacturing, the Senior Analytical Chemist is responsible for the generation, review, training and documentation of all analytical testing methods employed in the manufacture of new Radiopharmaceuticals at Molecular Insight in compliance with current Good Manufacture Practices. 

An advanced scientific degree is required in pharmacy or chemistry, with experience in the testing and release of pharmaceutical or radiochemical agents for clinical use. 

Specific Responsibilities

• Hands on development of new test methods and direct validation efforts
• Technical review of reports and documents submitted to QA and to RA for regulatory submissions
• Manage analytical instrumentation laboratory and maintenance schedules
  • Monitor adherence to SOPs and oversee version control and compliance
  • Monitor Radiation Safety compliance for handling and testing radioactive materials 

Qualifications

• PhD or advance degree in chemistry, biochemistry or pharmacy with 5-10 years experience
• Hands on experience with HPLC, TLC, GC, UV/VIS, LC/MS/MS and USP compendia methods.
• Strong interpersonal and multi-tasking skills.
• Experience with Word and Excel software.
• Motivated individual who can work in a multi-disciplinary team
• Experience in pharmaceutical GMPs 
• Experience in handling of radioactive material and ALARA techniques are desirable.
• Experience in the quality analysis of pharmaceuticals or radio-labeled compounds. 

Summary of Responsibilities

Reporting to the Senior Analytical Chemist, the candidate is responsible to perform test methods and generate data, perform release testing for critical components and final radioactive drug product for clinical supplies for a new prostate cancer imaging agent (Trofex) and a new melanoma therapeutic agent (Solazed). 

An advanced degree is desired, in pharmacy or chemistry. Experience in radiopharmacy or radiochemistry is a plus.  Experience in the analysis of pharmaceuticals or radioisotopes are required and expertise in HPLC and the analysis of chemical impurities is desirable.  The ideal candidate will be fully versed in cGMP requirements for pharmaceutical production and experienced at working with radioactive isotopes.

Specific Responsibilities

• Document, develop and apply strategies to ensure achievement of scientific objectives by monitoring/ evaluating the completion of tasks. 
• Perform chromatographic analytical testing for QC analysis of raw materials, intermediates, and small molecule drug products in cGMP environments
• Perform compendia testing to release parenteral pharmaceuticals.
• Generate and execute Standard Operating Procedures and analytical Test Methods,
• Complying with Quality control systems and Documentation requirements  
• Expertise in troubleshooting and maintenance of HPLC
• Assist in the identification of chemical impurity profiles of NCE’s.

Qualifications

• BS with >5 years, or MS with >4 years or Ph.D. with 0-2 years industrial experience. 
• Radiation safety training for handling gamma and Beta emitters,
• Experience in Good Laboratory Practices or Good Manufacturing Practices 

The Documentation Specialist will be responsible for maintaining and managing the company’s quality assurance documentation system(s) and files in a state of compliance with current regulations. Overall responsibility includes maintaining records for the quality management systems, which may include document review, writing, change control and archiving. The position is expected to maintain associated databases, files and reports as appropriate. The Documentation Specialist will also coordinate across development disciplines to ensure complete record management, and to aid in the design of efficient document control systems.

Responsibilities:

• Establish and maintain a compliant filing system (paper and electronic) for development knowledge management, as well as accurate and efficient document retrieval (onsite and offsite storage)
• Assist in the internal transition of paper to electronic files as required and coordinate legacy document transfer and filing for licensed product development compounds, as well as company-directed development activities
• Track deviations, CAPAs and change control and issue status and reminders on a timely basis to assist in proper closeout of these events
• Accurately issue documentation numbers to adequately track controlled documents
• Assist in new document creation and the revision processes
• Maintain the SOP history files and track the periodic SOP review
• Manage all controlled QA documents
• Manage the repository of company’s development files
• Issue control numbers for various documents and reports
• Assist in publishing various documents, including procedures and quality reports
• Assist in the development of Quality metrics for the function and in tracking other Quality metrics
• Assist in the QA review of various documents, including regulatory dossiers and reports
• Propose quality improvements to document control systems to maintain compliance and improve efficiencies
• Assist in the implementation of QA policies and procedures
• Regularly meet with the Director of QA to resolve issues, maintain time lines and plan in order to meet the company’s needs in the area of document control

Education/Experience Requirements:

• Associate/Bachelor degree in a relevant discipline or equivalent experience, or applicable combination. A technical background in research and development is preferred
• 5+ years’ experience with documentation systems, and 1-2 years’ experience in the drug, biopharmaceutical or medical device fields
• Experience in implementation and maintenance of electronic document management systems
• Demonstrated knowledge of document control systems within the FDA-regulated environment
• Must be well organized and able to grasp system concepts and communicate their applications.
• Excellent oral and written communication skills for effectively interfacing with all departments internal and external to the company
• Ability to handle multiple assignments in a fast-paced environment
• Competency in MS Office, Adobe Acrobat and documentation database systems
• Willingness to work in a dynamic environment with changing priorities
• Capable of quickly learning new quality systems
• Requires a flexible work schedule to accommodate multiple program priorities and international activities as needed

TITLE/ROLE: Senior Clinical Systems Analyst   

AREA: Statistical Programming

POSITION SUMMARY:
This position is responsible for developing and executing on procedures for raw data handling for Vertex clinical trials, from specification and receipt of data to handoff to other functions including DM, Biostatistics, and Statistical Programming.  This position will support business process related to standardized specification and data handling for many kinds and sources of data being used in Vertex clinical trials.   This position consults with end users to ascertain current business needs, clarify project objectives, and may support the deployment of business tools.  This position is responsible for high-level, complex trouble-shooting and issue resolution.

KEY RESPONSIBILITIES:  
-  Manages raw data acquisition and data downloading activities
-  Contributes to cross-functional / cross-department process improvement initiatives related to raw data handling and Electronic Data Integration Specification (EDIS) template improvements
-  Executes data conformance and checking tasks using programmatic tools for EDIS conformance checking and test transfer approval of clinical trials data
-  Contributes to the design of the Vertex Clinical Data Standards for the dataset structures of external data types
-  May assist with business administration for multiple systems (JReview, SAS Hosted Environment and IntraLinks, WebSDM, Open CDISC, etc.) including user administration, study registration, troubleshooting and vendor/GIS communication
-  Ensures project documentation is completed in timely manner while overseeing the quality of delivery, and general management of projects
-  Performs training on business processes by preparing and delivering relevant materials and exercises
-  Applies strong analytical skills to understanding business problems and technical solutions
-  Conducts presentations of technical issues, initiatives and projects at internal meetings
-  May develop or revise SOPs, Work Instructions, Guidelines, or other procedures

TECHNICAL AND COMMUNICATIVE SKILLS
-  Strong technical skills
-  Strong understanding of pharmaceutical drug development business processes, particularly in areas of DM, Statistical Programming, and Biostatistics
-  Has knowledge of software validation and system development life cycle concepts
-  Displays excellent verbal and written communication skills
-  High performance team player
-  Ability to multi-task activities independently and in an organized manner
-  Working knowledge of CDISC and programming

PREFERRED EDUCATION AND EXPERIENCE:
-  M.S. (or equivalent degree) and 4+ years of relevant work experience, or
-  B.S. (or equivalent degree) and 6+ years of relevant work experience

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases. Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science Magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist, and most recently was named the top employer in Science magazine's 2011 annual survey.

VERTEX is an Equal Opportunity/Affirmative Action employer. All employment decisions are made without regard to race, sex, national origin, color, religion, age, disability, veteran status or any other status protected by applicable law.

To Apply for this position, please CLICK HERE

Our client is seeking a Technical Writer with previous lab experience in authoring SOPs, technical protocols and reports to join their team to.  In addition to authoring SOPs/ technical protocols/ reports you will also contribute to data review and data interpretation/trending.  This position requires a BS in a scientific discipline, previous technical QC lab experience, and experience with GMP documentation.

Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

StratAcuity, CHEMISTRY IS EVERYTHING.

Looking for a candidate to ensure compliance with packaging standards and regulations.

Responsibilities:

-          In charge of proper packaging labels for all products

-          Train staff on labeling guidelines

Requirements: BS/MS with industry experience in label proofreading. Knowledge of CFR and CTFA label guide Regulations   

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in science, engineering and green technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise,advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

Sunovion Pharmaceuticals Inc. is dedicated to discovering, developing and commercializing scientifically advanced therapeutic products that are focused on helping patients suffering from central nervous system and respiratory disorders, as well as other illness.

HR Generalist                          2987           Marlborough, MA

The Human Resources Generalist will work closely with the HR Business Partners (HRBP’s), HR Centers of Excellence and management on HR initiatives that support business objectives. The role will engage with managers and employees to provide support in the areas of employee relations, performance management, talent management, benefits, and compensation. This position requires a high level of confidentiality and a passion for excellence to support the business.

•Serve as point of contact for managers and employees regarding HR policies, procedures, and programs
•Assist and support HRBP’s with various HR related functions including performance management, employee relations, employee engagement and recognition, corrective action, talent & succession planning, compensation, and staffing.
•Provide guidance and counsel to management team regarding applicable legal and regulatory compliance issues, company policy and effective management of their employees. Seek guidance of HR Business Partners as needed.
•Under direction from appropriate HRBP, manage employee relations inquiries. Evaluate issues and support resolution process including ownership of assigned investigative steps and action plan development and follow up. Provide coaching to key stakeholders within context of ER and PIP related discussions.
•Work with Compliance on any compliance related investigations.
•Coordinate aggregation and reporting of HR related matters such as employee relation activities, performance, compensation, promotions, etc. including trend lines.
•Manage the employee exit process. Conduct exit interviews, analyze data for trends and make recommendations for change, as appropriate.
•Ensure timely and effective administration of human resources programs; builds collaborative relationships across organization, to provide consistent and efficient services.
•Recommends new approaches, policies, and procedures to affect continual improvements in efficiency of department and services performed.
•Perform other duties as deemed appropriate for position level as directed.

Basic Qualifications

•Bachelor degree required in business or other related discipline.
•Minimum of 3-5 years experience in HR as well as working in a fast paced customer/client centric professional environment. Previous life science experience preferred.
•PHR or SPHR preferred

To learn more and apply, please visit Career Opportunities at the Sunovion Pharmaceutical website:http://www.sunovion.com/careers/find-career.html

PAREXEL will be exhibiting at the SoCRA Annual Conference from September 21-23 at the Rio in Las Vegas - booth 21. We are scheduling on-site interviews for qualified candidates now! Please apply to this posting if you are attending and are able to meet up with us.

If you live in the Las Vegas area but are not attending SoCRA, we encourage you to apply for the opportunity to interview September 21-23 at the Rio.

As a Clinical Research Associate (CRA) at PAREXEL, you have the opportunity to be a true clinician and work on complex therapeutic studies. In addition you will act as the on-site resource for the other study team members.

You will have the greatest impact on drug and medical device clinical trials by working on-site with the clients, focusing on the clinical trial, while leveraging the resources of our in-house monitoring team. Because of our unique structure, you will spend less time on the administrative aspects of the trial, and will be able to focus on what you were trained to do ' developing close relationships with the sites and having a positive impact on the success of the trial.

Our travel model encourages efficiency so you have more time for meaningful work activities. We are also organizationally and technologically equipped to support your focus on the clinical aspects of your work whether you are on the road or in your office.

We are seeking independent professionals who have the ability to see the big picture and communicate effectively. If you are organized, have strong attention to detail, are able to build lasting relationships with internal and external clients, and demonstrate excellent communication skills ' we want you to be the new face at PAREXEL.

Our management is committed to our internal environment of excellence, offering development opportunities and sponsoring initiatives for those employees who bring professional level skill and dedication to their careers. At PAREXEL, you will maximize your ability to reach your personal development and professional career goals.

To qualify, you should have a minimum of 1.5 years of on-site clinical monitoring experience (3+ years for Senior CRA).

PAREXEL will be exhibiting at the SoCRA Annual Conference from September 21-23 at the Rio in Las Vegas - booth 21. We are scheduling on-site interviews for qualified candidates now! Please apply to this posting if you are attending and are able to meet up with us.

If you live in the Las Vegas area but are not attending SoCRA, we encourage you to apply for the opportunity to interview September 21-23 at the Rio.

As a Clinical Research Associate (CRA) at PAREXEL, you have the opportunity to be a true clinician and work on complex therapeutic studies. In addition you will act as the on-site resource for the other study team members.

You will have the greatest impact on drug and medical device clinical trials by working on-site with the clients, focusing on the clinical trial, while leveraging the resources of our in-house monitoring team. Because of our unique structure, you will spend less time on the administrative aspects of the trial, and will be able to focus on what you were trained to do ' developing close relationships with the sites and having a positive impact on the success of the trial.

Our travel model encourages efficiency so you have more time for meaningful work activities. We are also organizationally and technologically equipped to support your focus on the clinical aspects of your work whether you are on the road or in your office.

We are seeking independent professionals who have the ability to see the big picture and communicate effectively. If you are organized, have strong attention to detail, are able to build lasting relationships with internal and external clients, and demonstrate excellent communication skills ' we want you to be the new face at PAREXEL.

Our management is committed to our internal environment of excellence, offering development opportunities and sponsoring initiatives for those employees who bring professional level skill and dedication to their careers. At PAREXEL, you will maximize your ability to reach your personal development and professional career goals.

To qualify, you should have a minimum of 1.5 years of on-site clinical monitoring experience (3+ years for Senior CRA).

 CODING SPECIALIST -- CLINICAL DATA

6+ month contract at Millennium Pharmaceuticals via Randstad

To apply, email your resume to Kayla.Vatalaro@mpi.com.

Position Summary:  Codes all applicable clinical trial data with standardized terminology and participates in the development of database standards and data management procedures that relate to clinical data coding

Duties and Responsibilities:

• Codes adverse events, concomitant medications and other data as needed using standardized terminology (MedDRA, WHODD) and in compliance with company coding conventions and guidelines
• Develops and reviews coding listings to ensure accuracy, completeness and consistency of the coded data.
• Contributes to the revisions of the MPI coding convention document
• Monitors timelines to ensure deadlines are met for data cuts and database lock activities
• Participates in serious adverse event reconciliation process by ensuring coding in Pharmacovigilance database is consistent with adverse event data captured on Case Report Form
• Assists the Senior Manager, Coding with projects as assigned

Qualifications:

Experience:  BS/RN/RPH or degree in health-related field with 2-3 years of coding experience in the pharmaceutical/biotechnology industry; knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management; experience in the oncology and inflammation fields desired

Other:

• Detail orientation
  • Effective written and verbal communication skills, interact professionally with personnel at all levels; dependable and a team player
  • Capable of working on multiple projects simultaneously, independently manage responsibilities according to deadlines
  • Expertise using MedDRA and WHODD
  • Knowledge of coding tools (dsNavigator preferred)
  • Certified MedDRA coder preferred