Are you interested in biotechnology and the regulations surrounding this highly progressive industry? If so, CBR International Corp. may be interested in you. We are a global, full service, biopharmaceutical and device consulting firm located in Boulder, Colorado.

Individuals with either Biotech/Pharmaceutical Industry experience or FDA experience are HIGHLY encouraged to apply. We offer competitive salaries, benefits, bonus programs, and career development. Positions do not necessarily require relocation.

CURRENT OPPORTUNITIES:

• Vice President/ Senior Clinical Program Manager
Job requirements:
• Master’s, PhD, DVM or MD from an accredited college or university.
• Additional related certifications, highly desirable.
• 5+ years of relevant clinical research experience required.
• Knowledge & understanding of FDA CFR & ICH GCP & strategies for implementing systems & processes to meet their requirements is fundamental.
• Skill in: Guiding clinical consulting teams, working with employees and regulatory agencies; Communicating clearly and concisely, both orally and in writing; Operating personal computers; Managing multiple projects, duties and assignments; Ensuring compliance with all company policies and procedures, including safety rules and regulations.
• Must be able to plan, organize and lead long term clinical consulting programs
• Must be able to effectively manage two to six people
Job description:
Supervising routine internal & external audits, system audits, vendor audits & for-cause audits as necessary. Managing and conducting audits of clinical & regulatory documents ensuring the quality, accuracy & completeness of the various documents, including but not limited to Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures & IND/NDA components.
Working with senior CQA personnel in regulatory authority inspections. Writing, reviewing and revising CQA SOPs. Providing consultancy to other departments on quality/regulatory related issues. Assisting with the development & execution of CQA goals to ensure regulatory compliance

5 year plus medical/clinical writing. Position open immediately. Please call 720-746-1190 for details.

•Vice President/Senior Managing Scientist
Job requirements:
• Master’s or PhD degree in a scientific or technical field required
• 5+ years of direct work experience including providing scientific advice and expertise in drug and/or device/diagnostic development
• 3+ years of relevant work experience including direct involvement with drug and/or device/diagnostic development in a project management role.
• MUST have experience as a TRUE Project Manager (not just a project leader in a group) - a Project Manager who has experience overseeing various programs for a company. Certification in Project Management preferred.
• Sound understanding of biotech, diagnostic or drug product development activities & of multi-project planning & coordination.
• Proficiency with using Microsoft Project, Outlook, project management tools, spreadsheets, Power Point, Visio & document management tools.
Job description:
Responsible for all project management activities related to the commercialization of products. Provides leadership & strategy for a team that supports the development & launch of both diagnostic & therapeutic products. Manages new product technology & product transfers as well as major functional projects. Builds bench strength in the project management organization & maintains a team with clear accountability that drives for results. Provides training & coaching to department, project team & key stakeholders on project management.

Responsible for providing Senior Scientific advice to clients and consultants. Writes, reviews and edits client documentation for submission to regulatory agencies world wide. Understands and is sensitive to client needs and can correctly position communications to address the issues which are most important to the client.

Responsible for communicating issues affecting project timelines to Senior Management. Applies project management tools, processes & principles to ensure consistent success. Utilizes & builds cross functional teams to address projects from a matrix perspective. Develops project plans, schedules, & work breakdown structures for assigned projects, while managing competing timelines & prioritize critical tasks. Identifies project resource needs, resolves resource conflicts & assembles project team members.

Implements tools, techniques & processes to enable informed decision making by the project teams, management, project sponsor & Operations Committee as appropriate. Ensures project goals & objectives are well understood by the project sponsor(s) & impacted functional areas. Liaison within cross-functional & project teams as required to accomplish project milestones. Provides project leadership to guide the project team & stakeholders from concept to delivery. Effectively communicates project progress to all levels of the organization, generates periodic updates & prepares formal presentations for required forums. Ensures project work complies with policies, standard operating procedures & regulatory requirements. Participates in required meetings, activities, & related projects & relevant interdepartmental activities.

Directly supervise employees in the Research & Development Department. Carry out supervisory responsibilities in accordance with the organization's policies & applicable laws. Responsibilities include some training of employees; planning, assigning, & directing work that is planned to meet project & program goals & objectives; appraising performance; rewarding & disciplining.

•Information Technology Assistant
Job requirements:
• Bachelor’s Degree from an accredited college or university preferred.
• Additional related certifications, highly desirable.
• 2+ years experience troubleshooting IT related issues.
• Available to work “on call” during non-traditional work hours.
• Skill in: Communicating clearly and concisely, both orally and in writing; Operating personal computers; Managing multiple projects, duties and assignments; Establishing and maintaining cooperative working relationships with others; Ensuring compliance with all company policies and procedures, including safety rules and regulations.
Job description:
Assist the IT Manger with maintenance of all equipment including but not limited to servers, workstations, laptops, and printers as well as provide support to users. Must be able to troubleshoot problems both in the office and over the phone, configure new equipment and perform routine maintenance.
Assist with the transition to electronic ANDA submissions utilizing the eCTD format. Participate in the definition of new internal publishing processes and implementation of publishing software. Work with Information Technology and/or vendor on business problem resolution and enhancements. Participate in the testing and piloting of new electronic software tools, and submission types.
Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.

• Senior Quality Manager
Responsible for reviewing, preparing, & overseeing all aspects of CMC quality compliance, and will also be responsible with the overall implementation of quality systems, processes & procedures within Chemical Development, Pharmaceutical
Development, Preclinical Development & Commercial Operations functional areas.
BS/BA degree or equivalent experience in a CMC QA decision-making capacity with 9+ years in a FDA regulated industry, preferably in drugs or biologics.

• Lead Document Associate/File Clerk
Organize and maintain client documentation, clinical library and company files.
Bachelor’s degree preferred.

• Clinical/Regulatory Associate
Provide clinical and regulatory support, clinical audits, technical writing and document management. Bachelor’s degree required, additional related certifications and pharmaceutical experience preferred.

• Document/Regulatory Associate
Provide professional advice on assurance and regulations, regulatory changes and updates. Provide document management assistance. Bachelor’s degree required. Additional related certifications and regulatory experience preferred.



Please submit a cover letter and your resume along with salary requirements to:

CBR International Corp.
Human Resources
2905 Wilderness Place, Suite 202
Boulder, CO 80301

Or email an electronic copy (MS Word format) to info@cbrintl.com

Or Fax to: Human Resources (720) 746-1192