Clinical Research Staffing stock photo
April 19th, 2016

Calculating the Cost of a Recall – 14 costs

Calculating the cost of a recall before it happens will help your executives understand how much to allot toward preventing a recall.

Calculating the Cost of a Recall - Value of Recalled Goods

Value of Recalled Goods 2014

You may think your company is under the government’s radar.

But, you are wrong!

Almost one-third recalls conducted in 2014 are from small companies under 5 employees.

Using data from the FDA and USDA we worked on calculating the cost of a recall. The average market value of products recalled in 2014 was $1,563,551 with a median of $33,598.  Small businesses make up the vast majority of recalled product. The visible cost of a product recall is just the tip of the iceberg. The majority of the total cost of a recall are the hidden costs as listed below:

$________________ Cost of Manufactured Goods

$________________ Product Disposal Costs

$________________ Change in Insurance Premiums

$________________ Business Interruption

$________________ Customer Reimbursement

$________________ Customer Damages

$________________ Retailer Reimbursements

$________________ Transportation

$________________ External Professional Fees

$________________ Sanitizing Production Facilities

$________________ Warehousing Costs

$________________ Internal Time and Expense

$________________ Loss of Brand/Reputation

$________________ Government Fines and Penalties

Take Action!

  1. Follow FDA Warning letters and USDA Recalls to monitor actions against your competitors, suppliers and vendors.
  2. Contact MEIRxRS about mock audits or to audit your suppliers.
  3. Share this page with your colleagues.
  4. Insure vacancies on your Quality team are filled quickly using full-time recruiting services
  5. Learn about our Quality Control Apprenticeship Program

Contact MEIRxRS for Auditors

Fill out my online form.
April 13th, 2016

Clinical Research Staffing Agencies

Clinical Research Staffing Agencies cut the Time to Succeed

Clinical research staffing agencies cut the time for your clinical trials to succeed

Clinical research staffing agencies like MEIRxRS reduce your employment costs, reduce risk and increase flexibility.

Because balancing the demands of both your investors and FDA regulators isn’t easy.

We reduce your employment costs by allowing you to only pay for the skill set you need, with very little training or ramp-up time. And our thorough search process will insure we find the talent required for your clinical trials to produce high-quality results for FDA approval.

Contracting offers tremendous staffing flexibility to complete projects and meet deadlines. The option for a contract-to-direct conversion also provides flexibility by allowing you to “try” the candidate before “buying” as a direct hire. In today’s changing economy, flexibility is often the key to survival.

Contracting eliminates the risk tied to workers’ compensation, unemployment, benefits, and the normal exposure related to having traditional employees.

Quality, Regulatory, Medical and Clinical Expertise

We’ve been interviewing candidates in our fields for over 25 years so why do it yourself? Our team includes CEO, Rosemarie Christopher, who has been a member of Regulatory Affairs Professional Society for over 25 years, ASQ for 24 years and serves on USC School of Pharmacy, Board of Councilors. She has been recruiting in this line of business for 24 years. Lewie is our recruiter dedicated to just regulatory and quality searches. He has been with us 10 years and is an active member of the Orange County Regulatory Affairs Professionals. Jan is our recruiter dedicated to clinical research and medical affairs positions. She has been with us for 20 years

What would you like to do next?

  1. Speak with someone about my staffing needs
  2. Submit my resume
  3. See our Staffing Capabilities
  4. Learn about full-time recruiting services

Speak to Someone About My Staffing Needs

Fill out my online form.
March 17th, 2016

Startup Incubator Labs in Southern California

Startup Incubator Labs are a great place for founders to build their pharma, biotech or medical device company. We’ve built a list of area labs for you. If you’re thinking to start your own business, looking to network with or do business with local startups use this list to find an incubator that’s a fit for you.

View Startup Labs SoCalBiotech Referral Group in a full screen map

Labs Included:

Log in and leave a message below to welcome people to your lab or let them know of your experience.

March 11th, 2016

Clinical Project Manager (Part-Time Contract ) – Philadelphia, PA

A Clinical Project Manager (part time contract) is needed for a Contract Research Organization (CRO) to work in their office in the Philadelphia area. This position will report directly to the Chief Medical Officer and includes responsibility for coordinating and managing all aspects of clinical study activities to maintain regulatory compliance and meet company timelines and goals for the clinical development program.  Looking for a highly-motivated and results-oriented individual.

REQUIREMENTS:

  • BA/BS, Health/Biology/Life Science required; Master’s degree is preferred
  • 5+ years clinical study management experience in biopharmaceutical industry, including 2+ years as a clinical study lead or project manager is required; global clinical trial experience is highly preferred
  • Study project management experience and prior management of contracted resources/CROs is required; site monitoring and clinical quality compliance experience are preferred
  • Strong knowledge of Good Clinical Practices and current knowledge of FDA regulations for pre-IND/IND applications; international clinical trial experience and knowledge of other country regulatory requirements is preferred
  • Strong operational management and attention to detail is required
  • Willingness to travel up to 30% of time, including domestic and international travel is required
  • Advanced computer skills including proficiency in Word and Excel are required; experience with PowerPoint is preferred
  • Excellent communication skills (oral and written) and interpersonal skills are required
  • Must be comfortable working in veterinary sites surrounded by pet animals

Contact:
Jan Clements
MEIRxRS
jclements@meirxrs.com

Contact Jan/Submit Your Resume

Fill out my online form.
February 2nd, 2016

Clinical Affairs Director – TX or Upper Midwest

Clinical Affairs Director will lead and manage the Clinical Affairs Department globally, reporting to the VP of R&D.

REQUIREMENTS

  • PhD Molecular Biology/Biochemistry with 7 years clinical research experience, or MS with 10 years clinical research experience
  • Clinical trials management experience leading to successful 510(k) and/or PMA submissions
  • Minimum of 10 years’ experience in a GMP and/or FDA regulated environment
  • 3 years International clinical trials experience

The Clinical Affairs Director will lead and manage a department globally. The main focus is the clinical validation of new in vitro diagnostic products. Will collaborate with Research, Regulatory, Scientific Affairs,and Sales & Marketing departments. Will ensure that the conduct of clinical research studies are in accordance with regulations and standards (e.g. 21 CFR part 812, CLSI, ICH, etc). Will also be responsible for the department’s administrative duties and the preparation and monitoring of the departmental fiscal year budget. Reports to the VP, R&D. Travel may be 20% of the time; International travel may be 10% of the time. Position may be at the office in TX or the upper Midwest.

Contact:
Jan Clements
MEIRxRS
jclements@meirxrs.com

Contact Jan/Submit Your Resume

Fill out my online form.
January 22nd, 2016

Personality Profiling: STEM Professionals in the New Economy

STEM Professionals need a range of skills to succeed in the new economy. Learn what key characteristics employers are looking for in technical hires.

ASQ Inland Empire Sections 706 and 711 will be profiling the STEM professional for the new economy that will be presented by our very own Rosemarie Christopher.

In this day and age, companies are being more selective as far as educational background, social media reputation, personality profiling and skills testing, subsequently making it harder for those that are looking to be hired land a job.

Topics

  • What makes you a GREAT performer in the new economy
  • Interpersonal traits that make you the power team leader at work
  • Understanding your personality profile to advance  your career

Her presentation will go over these issues, and help you explore your strengths and weaknesses in the workforce to help you better prepare for entering the workforce and landing that job, keeping it, and moving forward in your professional career.

Locations

ASQ Chapter 711 Meeting
Wilden Pump
22069 Van Buren Street
Grand Terrace, CA 92313 (map)
01/20/2016 @ 7:15pm PST

ASQ Chapter 706 Meeting
Ali Baba Persian Restaurant
17513 Chatsworth St.
Granada Hills, CA 91344 (map)
02/16/16 @ 5:30pm PST

ASQ Chapter 708 Meeting
Holiday Inn
2725 Palomar Airport Rd
Carlsbad, CA 92009(map)
04/13/16 @ 5:30pm PST

Download the Presentation

* indicates required



Professional Interests


January 20th, 2016

Clinical Studies Manager – Austin, TX

Clinical Studies Manager plays a major role in coordinating clinical studies, from qualification of clinical study sites through monitoring of clinical study activities and completion of clinical trials.

Required Education/Training:

  • Minimum MS/PhD in Molecular Biology, Biochemistry or related discipline with at least 3 years’ related experience in clinical trials OR
  • Minimum BA/BS degree in Molecular Biology, Biochemistry or related discipline with at least 6 years’ related experience in clinical trials

Required Work Experience:

  • Training & work experience in document and record management for clinical study (GCP)
  • Must have good understanding of 21 CFR Part 812 regulations and CLSI guidelines
  • Experience in a GMP and/or FDA regulated environment
  • Experience working independently in a fast-paced environment with rapidly changing priorities, as well as working well in a team-oriented environment
  • Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Can exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Strong organizational skills and exceptional time management and prioritization skills
  • Excellent verbal and written communication skills
  • Must work onsite
  • Travel may be required, including approximately 10% International travel

Clinical Studies Manager Key Responsibilities

This position is responsible for managing clinical study activities. The position plays a major role in coordinating clinical studies, from qualification of clinical study sites through monitoring of clinical study activities and completion of clinical trials. The position helps to ensure that clinical studies are executed in compliance to applicable regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH). The position also involves writing of study protocols, reports, SOPs and other documents.

  • Manage the planning and execution of clinical studies
  • Play a leading role in the qualification of clinical trial sites
  • Coordinate collection and tracking of clinical study specimens
  • Participate in clinical site training, monitoring, and support
  • Play a role in the analysis and interpretation of clinical trial data
  • Establish scientific methods for design and implementation of study protocols and data collection systems that meet quality and regulatory requirements
  • Prepare clinical study final reports
  • Monitor adherence to protocols during clinical studies and determine study completion
  • Participate in project core teams by presenting clinical study status updates and data
  • Manage clinical trial resources and timelines in coordination with project core teams
  • Interact with various internal/external groups to facilitate completion of studies for inclusion in regulatory submissions for in vitro diagnostic devices
  • Conform to applicable regulations and standards and company quality policies

 

Contact:

Jan Clements

MEIRxRS

Jclements@meirxrs.com

 

Contact Jan/Submit Your Resume

Fill out my online form.
January 9th, 2016

Clinical Pharmacist, Los Angeles

Requirements

  • Oncology experience
  • 2 years experience after boards
  • Current pharmacy licensure in State of California
  • Eligibility to obtain an NPI and DEA number
  • Good standing with State Boards of Pharmacy
  • ASHP accredited residency in Primary Care or equivalent experience

Summary

  • Provide clinical pharmacy services for providers and patients at an oncology research institute.

Contact

Paul Dionne
818-552-2625
pdionne@meirxrs.com

January 8th, 2016

VP Clinical Operations in San Diego, CA

Education & Experience:

  • Oncology experience
  • MS/PhD degree or similar
  • Extensive operations experience
  • Minimum 10 years clinical research experience
  • Minimum 8 years direct management

Position

  • Lead clinical operations team for an oncology company with 6 open clinical trials (phase I-III)

For more information about this type of page visit our VP of Clinical Operations page.

Contact

Paul Dionne
818-552-2625
pdionne@meirxrs.com

January 8th, 2016

VP Medical Affairs in San Diego

Education & Experience:

  • MD required
  • Oncology experience required.
  • Minimum of 10 years’ experience
  • Minimum 5+ years of supervisory experience

Position

  • Build a Medical Affairs team
  • Lead MSLs to develop and maintain key opinion leader relationships
  • Develop and execute the Medical Affairs strategy (pre-launch and post launch)
  • Phase IV clinical trial strategy

For more information about this type of page visit our VP of Medical Affairs page.

Contact

Paul Dionne
818-552-2625
pdionne@meirxrs.com

 

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