Clinical Research Staffing stock photo

Clinical Affairs Director – TX or Upper Midwest

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.

STEM Professionals in the New Economy

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

Subscribe to our mailing list

* indicates required



Professional Interests


Clinical Studies Manager – Austin, TX

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.

Clinical Pharmacist, Los Angeles

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

VP Clinical Operations in San Diego, CA

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

VP Medical Affairs in San Diego

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

 

Medical Device Compliance Auditor – 2 positions

January 7th, 2016

Medical Device Compliance Auditor for Boston or Minneapolis Area

Medical Device Quality and Regulatory Compliance professionals needed for two opportunities to assess non-active medical devices and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related client and project management

  • 50% Audit
  • Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD), Canadian Medical Device Regulations (CMDR), Japanese Pharmaceutical Affairs Law (JPAL) and International quality system standards (e.g. ISO 13485)
  • 50% Technical Document Review
  • Perform evaluations of regulatory submissions including: Clinical, Design Dossier, Technical File Review

Requirements:

  • BS Degree in a science related field, advanced degree preferred
  • 5 years of experience in an industrial medical device environment in either Orthopedic Implants, Single Use Medical Devices, Sutures and Staplers, or Catheters
  • 2 years of Quality preferred
  • Direct auditing experience Medical Device Directives is a plus
  • ASQ Certification (CQA, CBA, etc.), ISO 13485 and/or Lead Auditor Certification is desired
  • Regular domestic travel and occasional international travel is required

 

Contact:

Lewie Casey

Talent Manager

MEIRxRS

lcasey@meirxrs.com 818-552-4173

Contact Lewie/Submit Your Resume

Fill out my online form.

GMP Regulations for Friday the 13th

November 13th, 2015

GMP Regulations for Friday the 13th

Happy Friday the 13th! Remember, if you need a GMP or Quality specialist who knows the regulations below then don’t be scared. Call MEIRxRS.

United States – Food and Drug Administration GMP Regulations


Australia – Therapeutic Goods Administration


Canada – Health Canada


China


European Union – European Medicines Agency


India – Central Drug Standard Control Organization


Japan – Pharmaceuticals and Medical Devices Agency

Quality Apprenticeship Program Featured on CA.gov

November 11th, 2015

Quality Apprenticeship Program Featured on CA.gov

Quality Apprenticeship on CA.gov website

Quality Apprenticeship on CA.gov website

The State of California, Department of Industrial Relations has listed our two Quality Apprenticeships: Chemistry Quality Control Technician and Microbiology Quality Control Technician. These represent two out of the three apprenticeships available in the Health Services category.

The Division of Apprenticeship Standards (DAS) creates opportunities for Californians to gain employable lifetime skills and provides employers with a highly skilled and experienced workforce while strengthening California’s economy. MEIRxRS apprenticeship program supports this mission by requiring apprentices to work toward an industry certification while they are enrolled in the apprentice program. Each certification requires a mix of training and experiential learnings. Apprentices are paired with mentors who can provide guidance and support for the duration of the one to two year apprenticeship.

Our apprentices can be deployed in any FDA-regulated industry (food, biotech, pharmaceutical, medical device, nutraceutical, and cosmeceutical). Our grants cover the cost of training and mentoring the apprentice. If a mentor is not available within the host company, MEIRxRS will identify one.

The Quality Apprenticeship program helps businesses in multiple ways. Apprentices can help the company achieve a business objective. Currently, apprentices are helping small companies to comply with Food Safety Modernization Act (FSMA) regulations. Others are helping food companies pass third-party certification audits required to land new customers. To see apprentices in action watch the video on our FSMA page or read Four Ways to Use Apprentices to Improve Food Quality.

The apprenticeship program is designed to help military veterans, mothers returning to work, recent graduates and people coming off disability (such as cancer survivors) to return to the workforce.

What Do You Want To Do Next?

  1. Learn about the Quality Control Technician Apprentice Program
  2. Speak with someone about my staffing needs
  3. Learn about full-time recruiting services
  4. Submit my resume

Save the Date: SoCal Food Industry Conference March 2016

November 2nd, 2015

The 2016 Southern California Food Industry Conference theme will be Feeding A Hungry World: Knowledge, Nutrition, Compliance.

SAVE THE DATE – Outlook Calendar Item

March 10, 2016
8:30AM – 3:00PM

Disneyland Exhibit Hall
1150 Magic Way
Anaheim, CA 92802

CONTINUING EDUCATION CREDITS AVAILABLE

Speakers Include:

  • Dominique Brossard, University of Wisconsin, Madison, On Science and Communications
  • Jim Painter, Sun Maid Growers Fats in Vogue, Wheat Woes, u-oh GMOs
  • TBD: FSMA
  • TBD: Water Conservation

EVENT HELD IN CONJUNCTION WITH 2016 SCIFTS Suppliers’ Night Expo, which is an excellent opportunity to find new suppliers or showcase your own products.

March 10, 2016
3:30 p.m. until 8:00 p.m.

Disneyland Hotel Exhibit Hall
1150 Magic Way
Anaheim, CA 92802

 

Logos of our membershipsmore Logos of our memberships