Clinical Research Staffing stock photo
July 12th, 2016

Clinical Research Services

Clinical Research Services help optimize your development timelines, whether your company is developing a biologic, drug or medical device. We offer a range of services to help you achieve your objectives.

We have separate legal entities (staffing, recruiting and CRO). Each helps you solve your problems and remain in compliance during your development.

For example, our Clinical Research Organization helped our client to build a custom team and turn around a study that was receiving poor data from clinical trial sites. The client said we produced the cleanest data and technical writing the Client had ever received. Further, we saved the Client at least $900,000 in labor costs in 1 year according to their measures.

During early-stage development, turn to us to vet and find the best consultants experienced in your therapeutic area. Our expertise is in Clinical, Regulatory and Quality. These consultants will keep you on track with your regulatory submissions. They will insure your data and product quality support a successful first time FDA approval.

You will also rely on us to plan for the development of your team. We understand the critical inflection points (e.g. preclinical to phase I) when your company will need new talent. We also understand stages at which you will need to seek investor funding, whether through venture capital or an IPO. You can rely on our Executive Search services to dig deep and source candidates to aggressively find the talent your investors want to see.

As your company moves into Phase III and Phase IV, rely on us to serve as your RPO (Recruitment Process Outsourcing).

June 27th, 2016

Brexit and Biotech

Brexit and Biotech don’t mix.

Graph of Brexit and Biotech vs Dow

While the the biotech index is more volatile than the Dow normally, there is a sharper decline today. This is a reflexion of how Biotech will be impacted by Brexit Tweet: a reflexion of how #Biotech will be impacted by #Brexit http://ctt.ec/k24Ua+ #clinicalresearch #clinicaltrials :

  • London is a popular IPO market for many biotechs
  • Some US biotech IPOs have launched in Europe
  • European Medicines Agency (EMA) headquarters is in London
  • Brexit may impact EU companies looking to raise capital in London
  • Companies like Activas engaged in reverse mergers to move their headquarters to EU countries like Ireland to take advantage of lower corporate taxes
  • Brexit slump is on top of the February 2016 slump due to drug pricing debate
  • There will be US Congressional hearings to scrutinize drug price increases
  • There are likely to be greater currency fluctuations between the Dollar, Euro and Pound
  • New currency exchange rates may make previously arranged deals unattractive (e.g. Bayer/Monsanto)
  • R & D is increasingly global
  • Companies conduct their clinical trials globally
  • The exit will impact regulations on companies selling biotech drugs and devices in the UK

In the short run, this is another setback for pre-clinical and clinical-stage companies who need to fund their research with investor money. A sentiment echoed by Dr Banks in GEN News Pharma and Biotech Respond to Brexit:

“Short-term I expect the impact to be minimal to Pharma, perhaps a financial hit to their stock.  Depending on the burn rate of individual biotechs, the short term effect could be significant if investors are losing patience.  Probably the biggest impact long term for both will be in human resources, but this will depend on what EU exit package is negotiated between Britain and the EU. Only time will tell what that is.”
Peter Banks, Ph.D., Scientific Director, BioTek Instruments (US)

June 20th, 2016

CE Marking Roadshow Comes to SoCal

Akra and von Hahn will speak about CE MarkingCE marking approval in Europe is being influenced by new regulations. These medical device regulations are replacing the current CE requirements outlined in medical device directives that dictate how your product achieves a CE mark.

For more information visit TÜV SÜD Roadshow events


Irvine CA Event Details

 CE Marking Approval in Europe – Irvine 

Organizer:  TÜV SÜD MHS 

Date Time:  August 10, 2016 ,   8:15 AM

Duration (hours) 04

Location:

Avenue of the Arts Costa Mesa  3350 Avenue of the Arts  ,  Costa Mesa  ,  CA   


San Diego CA Event Details

 CE Marking Approval in Europe – Irvine 

Organizer:  TÜV SÜD MHS 

Date Time:  August 11, 2016 ,   8:15 AM

Duration (hours) 04

Location:

Avenue of the Arts Costa Mesa  530 Broadway  ,  San Diego  ,  CA   

 

June 17th, 2016

Staffing Agency Fees

Staffing agency fees include base pay, taxes, benefits and overhead. Staffing Agency Fees are Based On Employee Pay and Benefits shown in chart

 

Using data from March 2016, the Bureau of Labor Statistics (BLS), the average US employee earned earned $23.25 per hour. Employee benefits cost employers $10.70 per hour for a total of $33.94 per hour.

Staffing agencies usually quote their fees as a multiplier of the employee’s base pay.   The BLS data demonstrates that the first 1.46 of staffing agency fees covers wages, taxes and benefits ($33.94/$23.25 = 1.4597).

Agencies typically charge between 1.65 and 2.10 times the employee’s base salary. The rate will reflect the demand of the skill set needed, difficulty of the search and number of available candidates. The fees above 1.46 contribute to the viability of the agency. The fees also cover the agency’s overhead costs (phones, computers, rent, filing taxes, salaries) needed to provide value to the customer.

The value an agency like MEIRxRS provides includes finding the right temp or temp-hire employee.  As the survey from our partner recruiters in Top Echelon demonstrates, agencies uncover the best candidates through their network of referrals, internal databases, and cold calling with just a small fraction coming from ads or social media.

June 17th, 2016

Oncology Research Nurse

An Oncology Research Nurse is needed by our client in Santa Monica, CA. Candidate should have experience in Oncology and wants grow by serving patients enrolled in clinical trials.

Education Requirements:
*Experienced Oncology Nurse (RN required, OCN is a plus)
*CA License
  Qualifications
*Must be able to follow the protocol and see that it is followed
*Good communication skills and work well with patients and doctors
*Full-time Mon-Fri
*Must be commutable to W. Los Angeles

Responsibilities may include:
• Screening patients for inclusion/exclusion criteria for the clinical study
• Consenting patients
• Reviewing and/or reporting adverse events
• Reviewing con-meds
• Physical exams with the Dr or NP
• Communicating with the Sponsor and the Clinical Research Associate
• Nurse will be managing 10-12 study protocols
• Collaboration with other team members (including data managers, CRC’s, radiologist, PI’s, etc.)

Contact:
Jan Clements
MEIRxRS
jclements@meirxrs.com

Contact Jan/Submit Your Resume

Fill out my online form.


Oncology Research Nurse

 

Santa Monica, CA

June 16th, 2016

Biotechnology Jobs vs Biotechnology Careers

Biotechnology jobs are for short-term goals.

Biotechnology careers include your long-term goals. This journey must be managed through a combination of education, certifications and experience. Only then can you arrive at the destination you are most interested in.

Biotechnology jobs include Clinical Trials, Clinical Research, Quality, Regulatory, and Medical Affairs, Engineering and Software. Research in food, pharmaceuticals, biologics, and medical devices are sometimes lumped in with biotechnology.Keywords for biotechnology jobs and biotechnology careers

 

Skip to Search for Jobs

 

Let’s begin your career progression with the end in mind:

Senior Vice President

The Senior Vice President title is usually given to a Vice President with significant experience and or one who oversees multiple Vice Presidents. These include regional Vice Presidents or Vice Presidents of specific therapies.

More information can be found on our Executive Search page.

Vice President

Vice Presidents lead the entire team of a department such as Quality, Regulatory Affairs, Clinical Development, Medical Affairs. It may also include a line of business such as Oncology.  For more information, including job descriptions and major pitfalls visit our Executive Search page.

Head or Executive Director

The titles of Head of and Executive Director are uncommon in biotechnology. Typically, they are endowed when people have a particular expertise and an exacting level of performance is needed. Otherwise, a company could face devastating consequences. Examples include Head of Drug Safety, Head of Health Economics Outcomes Research (HEOR).

More information can be found on our Executive Search page.

Senior Director

A Senior Director is generally a Director with significant experience and may oversee the work of Directors and lower-level positions. Multiple industry certifications, 15 years or more of experience, and a Masters degree in science, technology, engineering or math (STEM) may be required for this level of position.

More information can be found on our Recruiting Page.

Director

By the time someone reaches Director level they ought to be considered a Subject Matter Expert (SME). They may have full responsibility for a subset of their department’s responsibilities, e.g. Director of CMC. Directors have management responsibilities for Associate Directors and below. At least one industry certification is usually required. Directors have 8-15 years of experience, more if the director does not have a Masters-level degree or higher.

More information can be found on our Recruiting Page.

Associate Director

Associate Director positions are not common. Some step directly from Manager positions into Director positions, depending on the size of an organization. Certifications are preferred at this level. More information can be found on our Recruiting Page.

Senior Manager

Senior Managers are responsible for managing their projects and perhaps managing a Manager and or team of specialists. More information can be found on our Recruiting Page.

Manager

Managers are responsible for managing their projects and perhaps managing one or two Specialists. More information can be found on our Recruiting Page.

Associate Manager

Associate Managers are generally responsible for managing their projects or a portion of a larger project. More information can be found on our Recruiting Page.

Associate or Specialist or Technician

Specialists typically have 0-4 years of experience and a relevant degree. In the case of biotechnology these are degrees in science, technology engineering, or math (STEM). These are line level positions that frequently perform repetitive tasks such as documentation, running tests, or assembling materials for submissions. Mentorship and oversight, whether formal or informal is critical at this stage. People who want to climb the ladder should begin looking at industry certifications at this point. More information can be found on our Recruiting Page.

Apprentice

Biotechnology apprenticeship program is exclusively offered through MEIRxRS. It is a plug-n-play training and onboarding program for companies that are looking for innovative way to draw people into biotechnology jobs. The program covers part of the cost of training and employing apprentices while they work toward an industry certification, typically one or two years. More information can be found on our Apprenticeship Program page.The current apprenticeship program includes:

Apply to Biotechnology Jobs

What would you like to do next?

  1. My company needs to find an executive.
  2. I’d like to submit my resume.
  3. Can I talk to a recruiter?
  4. I’d like to speak with someone about my permanent or temporary vacancies

June 8th, 2016

PRESS RELEASE

Rx Research Services receives US Department of Labor Certificate of Registration of Apprenticeship Program

Mentor Mas Hori and his Food Safety Apprentice Karnia recognized by RX Research Labor Certificate

Mentor Mas Hori and his Food Safety Apprentice Karnia

(May 30, 2016 Los Angeles, CA) STEM apprentices to get on the job training and employment as Microbiology Quality Control Technician Quality Control Technician, Regulatory Compliance Associates plus 6 more Apprenticeships in food and biotechnology industries

Imagining a shortened runway to professionalism in STEM employment in the United States is how the Rx Research Services got status as a Sponsor and Training Committee in the Federal & State of CA Apprenticeship program.

Though the Apprentice model is not new, Rx Research Services built on this best practice from the Swiss and Germans to create an American model for STEM Graduates and Veterans.

Entry level jobs are already a part of the rite of passage for young adults.  Apprenticeships, ‘on the job’ paid entry level work experiences utilize Subject Matter Expert Mentors, as well as online ‘plug and play’ learning packages.  This ensures a double win, jobs at Host companies which can realize in a very short time a return on their investment in the form of trained, experienced and certified individuals, doing the higher skills work of the new world economy.

In just over a year, Rx Research Services has completed creation and registration of 9 jobs with the State of CA Department of Apprenticeships.  The Federal DOL has approved two and is working to complete the vetting of the remaining 7 STEM jobs making them ‘apprenticeable’ for positions in the life sciences industries.

From June until December 2015, 3 STEM graduates and 2 Veterans were placed in California companies, the first STEM Apprentice compliance support for the Food Industries to the recently enacted Food Safety Modernization Act, (FSMA).

Practical education in the form of classroom learnings, on line studies and day to day practice at the Host company site, centers on the 5 basic FSMA requirements of the FDA for training, documentation and  implementation of SSOPs; GMP’s; Labeling, HACCP and Recall Planning.  While learning these things, the Apprentices under the mentor’s supervision prepare the documentation and implementation plans Food companies regulated for the first time in their history, need to meet FDA requirements.  Now that almost one dozen companies have Apprentices, with 15 more Apprentices to be placed in 2016, the proof of concept is completed and the program is prepared to launch throughout the State of CA.

May 20th, 2016

Good Manufacturing Practice (GMP) Expo

The Good Manufacturing Practice (GMP) expo is being organized by the International Society for Pharmaceutical Engineering (ISPE) Los Angeles Chapter. Good Manufacturing Practice (GMP)

The event will be held:
Thursday, May 26, 2016
Brouwerij West
110 E. 22nd St.
Warehouse No. 9
San Pedro, Ca 90731

You can learn more and see the agenda at the ISPE LA website.

MEIRxRS will be there because we provide talent that contributes to good manufacturing practice. This includes our Executive Search such as Vice President of Quality, providing 3rd party GMP & Quality Auditors, staffing temporary Quality positions, recruiting permanent Quality Engineers and Quality Assurance Professionals and providing QC Apprentices.

If you would like to schedule a time to meet and discuss either your career or your talent needs please contact :

Paul Dionne
pdionne@meirxrs.com

Attendees
Includes two technical sessions, 1 drink ticket and appetizers
($20 Members, $20 Non-Members)

Register Here

Exhibitors

Includes two attendees, 1 drink ticket per person, appetizers, one exhibit table
($805 Members, $805 Non-Members)

Register Here

 

 

May 17th, 2016

Commercial Development Director / Sales (East Coast, West Coast, Europe)

The Commercial Development Director will set a road map for the sales team. The client is a Contract Manufacturer that provides bulk drug formulation and manufacturing. They also provide primary and secondary packaging capabilities for solid dose drugs. Their technologies include granulation, coating, blending, encapsulation, compression and drying of tablets and capsules.

Preferred Experience

  • Bachelor’s Degree Science/Business
  • Five plus years of selling in the Contract Manufacturing market
  • Operational Experience

Main Responsibilities

  • Create and execute a 12-month plan
  • Prospect for potential new clients.
  • Cold call as appropriate within your market or geographic area to ensure a robust pipeline of opportunities.

Contact:
Paul Dionne
MEIRxRS
pdionne@meirxrs.com

Contact Paul/Submit Your Resume

Fill out my online form.
May 16th, 2016

Lab Apprentices —Building a Workforce in a Tight Labor Market

Lab Apprentices are now available for CLIA, CAP and 17025 labs in California.
Lab apprentices pipet

“We are pleased with [our apprentice] who has been valuable to effectively upgrade our quality control programs, bring a youthful vision and spirit to our workforce, and help us develop a competent team for the future,” said Kevin Kimura of Red Shell Foods, Inc. in Sante Fe Springs, CA.

We are hoping to bring the same satisfaction our food companies have to labs.

Quality is important in all industries, but it is particularly important in labs where getting the correct result the first time is critical. That’s why we require lab apprentices to get a quality certification (CQIA).  A number of labs have recognized that with FSMA regulations coming down, food testing will be a growing book of business.  The apprenticeship program can help them get a jump on their competitors and reduce lab turnover.

Lab apprentices are available under our federally and state-recognized Quality Apprenticeship Program. MEIRxRS  was published this month in the American Society for Quality’s Journal for Quality and Participation (free log-in) detailing the program.

Hiring managers consistently paint the picture of a shortage of skilled workers. Position descriptions frequently include requirements of between two to seven years of work experience. Employers need candidates who can hit the ground running without extensive on-boarding or training. This shortage of experienced and skilled workers has affected regulated industries, particularly in their ability to attract the right talent to serve customers well.

Read more at ASQ’s Journal for Quality and Participation.

 

 

 

 

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