Designing and Implementing Best Practices for Pharmaceutical, Biotechnology & CROs














    Principal Consultants

   
     
   
Consultants Experience



President and CEO, Rikki Hansen Bouchard, M.P.A.-Outsourcing, Contracts, Strategic Planning, Investigator Services, Proposals, Project Management
Rikki has over 20 years of pharmaceutical development and contract research organization experience. Her expertise includes account management, strategic partnering, project management, contract management, marketing, proposal development, business and technology solutions, site grants and contracts. She has held positions with two of the world's largest CROs as the Vice President of Contract Management and Proposals and Vice President of Worldwide Business Operations. (401) 624-7288, rikki@rhbassociates.com

Associate-MD, MBA, Drug Development Consultation, Due Diligence Review, Medical Expertise
Location: San Diego, CA

Over 18 years experience managing business and development operations in the pharmaceutical, medical device, biotechnology and CRO industries. Former President and CEO of a medical information technology firm; Vice-President and General Manager for San Diego Operations for one of the largest global CROs; President and COO for a number of start-up companies as well as serving as Medical Director for several large Pharma companies.

Associate-Attorney, Contracts, Training, Investigator Negotiations
Location: San Diego, CA

Six years of experience in Pharma/Biotech performing a wide variety of corporate transactional work; including preparation of clinical trial agreements for multi-center international clinical trials; prepare supply agreements, manufacturing agreements, master services agreements, consultant agreements and confidential disclosure agreements. Expertise in the implementation of HIPAA procedures and agreements.

Associates-Attorney, Contracts, Training, Investigator Negotiations
Location: Wilmington, NC

Over four years of experience managing the Contracts division of one of the world's largest CROs. Advised on all legal issues related to the commercial and operational aspects of CRO business, including drafting and negotiating contracts worldwide. Expertise in Clinical Trial Services Agreements, Clinical Consulting and Investigator Agreements for US, Latin America, Europe and Asia. Extensive knowledge in pharmaceutical industry, including FDA regulations, ICH guidelines, Good Manufacturing Practices guidelines, Good Laboratory Practices guidelines, and HIPPA.

Associate-Attorney, Contracts, Investigator Negotiations
Location: RTP, NC

Over 16 years of experience, including negotiation of agreements for a large Pharma client. Created and implemented a document automation system designed to streamline the high volume clinical contracting process.

Associate-Attorney, RN, MBA-Operations, Project Management, Investigator Negotiations, Outsourcing, Medical Writing, Training
Location: RTP, NC

He has over 15 years of in the Pharmaceutical, CRO and Biotechnology Industries. His professional experience extends from his being a Registered Nurse with expertise in clinical product development, program management, down-stream product lifecycle management, marketing, and program development for biotechnology and pharmaceutical companies. He also has significant expertise in major account development and management, strategic planning and tactical implementation for pharmaceutical and biotechnology companies. He has held positions as Head of Therapeutic Development for a leading University Research Institute and Managing Director for successful start-up companies. He is a Six Sigma Black Belt.

Associate-Attorney, Contracts, Investigator Negotiations
Location: RTP, NC

Over 20 years in the pharma and academia serving as general counsel and intellectual property attorney. Specializing in Investigator contract negotiation with academic centers, and large hospital groups.

Associate-Attorney, Contracts, Investigator Negotiations
Location: RTP, NC

20+ years contract experience including management, negotiations, review, bidding, investigation and litigation. Previously headed the Legal Department of a large ARO. Specializes in Investigator contracting with academic institutions and complex CTAs.

Associate-PhD, MBA, Strategic Sourcing, Product Strategy, Operations, Training
Location: Greater Los Angles, CA

Over 20 years of experience in strategic development, pre- and early clinical development and evaluation, project and partnership management, and clinical outsourcing; contract negotiation, change management and governance models. Six Sigma Black Belt.

Associate-Paralegal, Outsourcing, Contracts, Investigator Negotiations, Training
Location: Malvern, PA

Contracts manager, negotiator, and outsourcing specialist with extensive experience in the pharmaceutical and biotech industries. MBA and skilled negotiator with a proven track record for developing and implementing standards, policies and procedures to support companies' strategic goals. Experience also includes paralegal assistance to major law firms and corporations, with emphasis in the areas of general corporate, contracts, mergers and acquisitions, bankruptcy, licensing, trademarks, litigation and regulatory compliance.

Associate-MBA, Outsourcing, Contract Management, Licensing & Acquisitions, GCP and GMP Quality Assurance, Clinical Project Management, Technical Writing, Training, and Process Development
Location: Moorsetown, NJ

Over twenty-five years experience in the pharmaceutical, biotech, diagnostic, generic, and consumer industries that spans from discovery through commercialization in multi-therapeutic areas with a combination of scientific, regulatory, QA, manufacturing, and business credentials. Her expertise includes vendor assessment leadership, due diligence reviews, negotiations, supplier relationship management, Quality Assurance, Technical Training, and SOP writing.

Associate-MBA, Outsourcing, Contracts, Proposals, Training, Relationship Management
Location: Lincroft, NJ

20+ years in the pharma and CRO industry heading marketing, contracts and proposals groups as well as acting as a clinical project manager. Most recently served as a Vice President of one of the world's largest CROs.

Associate- Contracts, Finance, Investigator Negotiations
Location: RTP, NC

She has fifteen years experience in the pharmaceutical industry with experience in strategic planning, organizing solutions, proposal development, contract management, marketing, and finance. She has worked in management for one of the largest Pharma companies, as well as, an academic CRO and a startup SMO.

Associate-Outsourcing, Clinical Compliance
Location: RTP, NC

Clinical outsourcing professional with 20+ years of pharmaceutical industry experience, with an extensive background in the clinical research area; consulting focus is on assisting biopharma clients in optimizing the outsourcing process.

Associate-Healthcare Planning, Contracts, Proposals, Training, Finance, Investigator Negotiations
Location: Southern Florida

Over 30 years of experience in Healthcare. Expert in outsourcing management, contracts and proposals, as well as pricing models, and investigator services. Has been responsible for the management of preferred relationships and development of contracting models.

Associate-Operations, Project Management, Strategic Drug Development, Training, Investigator Negotiations
Location: Bay Area, CA

Over 10 years of experience in the industry with a background in exercise physiology and a degree as an RN. She has worked as a project manager, clinical manager, been responsible for patient recruitment both on-site and in an internet start-up. Her specialties include oncology, cardiovascular disease, urology, reproductive medicine, and orthopedics.

Associate-Medical Writing
Location: Greater Boston, MA

Over 20 years of experience as a PhD level academic researcher for a major Boston Medical Research Institution. Has worked as a freelance medical writer for the last 10 years. Specialty areas include protocol writing, manuscripts, abstracts, integrated reports.

Associate-Medical Writing
Location: Allentown, PA

Specializing in medical and technical articles for publication in journals and trade magazines. Over 20 years experience as a freelance writer with a Masters in genetics and hundreds of articles published.

Associate-Outsourcing, Contract Management, SOP Development
Location: Bay Area, CA

Over 7 years experience in outsourcing management and twelve years experience in SOP development and IND auditing within the pharmaceutical industry.

Associate-RPh, MS Drug Regulatory Affairs, Project Management, Operations, Regulatory Affairs
Location: New Jersey

Eleven years in the pharma and CRO industry, working in regulatory and medical affairs, project and clinical management. Assists with training, regulatory strategy, government contracting, arbitration.

Associate-Computer Programming, Web Portals, Technology Solutions
Location: RTP, NC


Application architect, designer, project manager, works closely with companies to understand needs and translate them into IT solutions. Fourteen years with large Pharma. Five years architecting and managing infrastructure projects and solutions in support of business. Six years establishing standards for desktop hardware, OS, and application deployment. Seven years engineering, designing, deploying LANs, network applications, and corporate telecommunications infrastructure. Twelve years facilitating local Microsoft user group.

Associate-Technology Development, Pricing Models, Proposal Development
Location: RTP, NC

She has over 8 years of experience working in a CRO developing tools and models for financial analysis, pricing models and proposal generation tools. Her expertise is in the programming of Excel based tools.

Associate-MBA, Outsourcing, Contracts, Training
Location: Bay Area, CA

Thirteen years of experience in outsourcing and provider relationship management and contracting. Expertise in Provider selection, outsourcing strategy, contract management and governance.

Associate-Contracts and Proposal Development
Location: Charlottesville, VA

Over thirteen years of experience with one of the world's largest CROs in the development of proposal systems, pricing and proposal defense. Expertise in outsourcing models, training, and contract management.

Associate-Project Management, Clinical Trial Management, Investigator Negotiations, Training
Location: Bay Area, CA

Over 13 years of experience in the industry with an emphasis on oncology clinical trials. She has worked as a project manager, clinical manager, been responsible for negotiation of investigator contracts and regulatory document processing.

Associate-Contract Management and Negotiations
Location: King of Prussia, PA

Over 10 year experience in developing and negotiating contracts and change orders for a major global CRO.

Associate-MSM, Investigator Contracts
Location: Madison Heights, MI

Over ten years of experience in preparing and negotiating investigator agreements for a major academic medical center.

Associate-Market Research, On-line Surveys, Focus Groups, Management Simulations
Location: RTP, NC

Uses a range of market research tools to solve management problems and drive business decisions. Over ten years of experience in healthcare market research.



   
   
   
     
RH Bouchard & Associates, Inc.
18 Brightman Avenue
Tiverton, RI 02878
Phone: 401-624-7288
Fax: 401-624-7289
Mobile: 508-292-7904
rikki@rhbassociates.com

 
 
Copyright 2007