Delivering on the promise of medical innovation begins at Boston Scientific
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Purpose:
In this position, you will be responsible for supporting compliance audits at Boston Scientific facilities located in interesting and exciting locations in the U.S. and throughout the world. You may facilitate support of audits of specific products, processes, or areas with the ability to apply and explain real world application of requirements, regulations and standards. You be responsible for working with QA management/teams on validation, protocol and process reviews, and implementation of requirements in compliance programs and Corporate Audit Support.
Key Responsibilities:
Plan and conduct Corporate Audit Support operations to support compliance with FDA, ISO, MDD, and internal requirements, encompassing both Medical Device and Pharmaceutical Good Manufacturing Practices.
Corporate Audit Support scheduling, analysis and presentation of audit observations, findings and reporting. Confirmation of follow-up actions is also key to this role.
Participate in planning, coordination, and implementation of Corporate audit support policies with Corporate and divisional leaders.
You will receive extensive, up-to-date training in order to review, understand, and implement changes related to ISO, QSR and cGMP requirements.
Incorporation of this information into Corporate and divisional programs through document reviews, protocol and validation reviews, and training programs, and participation with Corporate and divisional QA on policy/procedure/guideline development.
Qualifications:
Candidate possesses a B.S. Degree with 5-7 years experience in quality and regulatory for medical devices and pharmaceuticals. Additional requirements for this position include the following: training in audit techniques and a comprehensive working knowledge of FDA regulations and ISO guidelines. Other, ideal requirements would include a minimum of five years experience in Compliance Auditing in medical device, pharmaceutical and/or a comparable related environment, as well as certified auditor or lead auditor training. Knowledge of human anatomy and physiology is helpful.
The candidate must possess strong skills in report and quality metrics generation. Must have demonstrated competence in MS-Word, MS-Excel, MS-PowerPoint, MS-Visio, MS-Project, MS-NetMeeting, documentation management systems, and databases. Familiarity with Intranet tools such as SharePoint and Website design.
Working Conditions:
General office environment, with significant domestic and international travel to other BSC facilities for auditing and or/meetings and conferences.
Delivering on the promise of medical innovation begins at Boston Scientific
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Provide quality engineering support within technical development concepts, regulatory, operational, or system/services support.
Serve as mentor Quality technicians on implementing Quality processes and procedures as appropriate.
Duties and Responsibilities (including those within the quality system):
Applies technical quality engineering principles to assigned projects, products or sites and guides them into implementation.
Provide project direction, coaching, and mentoring for engineering and technical team personnel as appropriatev
Investigates, identifies, and implements best-in-class Quality Engineering practices as requested by management
Identifies and implements effective process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Potentially act as team member in supporting quality disciplines, decisions, and practices.
Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
Analyze Quality data for management reporting, and advise management on potential improvements or enhancement to quality systems and processes in the company.
Minimum Education & Experience:
MS in Engineering/Technical field. MBA is also preferred.
5-8 years of technical experience, 1-3 years minimum in medical device, pharma or biotech industry
ASQ certification is a plus.
Working Conditions:
General office environment, with occasional domestic and international travel to other BSC facilities and or/meetings and conferences.
Competency Expectations:
Good familiarity with the FDA, ISO, MDD and the Boston Scientific quality requirements associated with developing products in a regulated industry.
Good understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as ISO 13485:2003
Previous experience with Notified Bodies, Japanese, Canadian and Australian Regulations a plus.
Good communication (oral and written) and presentation skills.
Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.
Proficient with Microsoft Office Suite
Prof. Richard Rocco at San Francisco State University is organizing a session at the annual meeting of the American Association for Clinical Chemistry in Washington, D. C., in late July 2008. He is looking for someone who can present on the subject of the history, development, and influence of FDA on in vitro diagnostics. If anyone is interested or would like to know more about this session, please contact Prof. Rocco directly at rmrocco@comcast.net.
The primary duties of the Vice President, Clinical and Regulatory Affairs include the following:
1. Lead the preparation of strategic drug development plans inclusive of preclinical, manufacturing, regulatory and clinical development activities.
2. Provide scientific leadership to clinical project teams. Actively participate in designing and implementing of clinical development strategies and conduct regulatory review of clinical documentation for a diversity of development candidates for Summit clients.
3. Provide regulatory strategy and intelligence for due diligence and other corporate issues with full awareness and guidance from current regulations.
4. Serve as liaison with FDA on regulatory submissions and clinical development plans for product lifecycle on behalf of clients, as needed. Participate in telecons and face-to-face meetings with FDA.
5. Review and finalize clinical protocols and provide clinical oversight of trial implementation activities, as needed, including review and evaluation of safety data generated in clinical trials.
6. Contribute to the identification and acquisition of new clients.
Requirements:
M.D., Ph.D., or DVM degree from an accredited U.S. institution preferably with advanced training in oncology, infectious diseases, or cardiology. If Medical Doctor, a minimum of 3 years or equivalent experience as medical monitor for clinical trials conducted by pharmaceutical, biotechnology or contract research organizations and a minimum of 10 years experience as medical director (or equivalent if Ph.D or DVM) in the pharmaceutical, biotechnology or contract research organization industries or at FDA. Demonstrated ability and decision making experience with regard to clinical and regulatory development plans and clinical protocols and in the preparation of clinical sections of INDs. Successful candidates will have experience in designing clinical studies for a diversity of product classes and indications and will have experience in interacting with FDA and/or other regulatory agencies. Excellent interpersonal, organizational, writing, oral communication and presentation skills are a must.
Location:
This position is located in Summits Rockville, MD office. Full office amenities are provided. Local Candidates Preferred.
Interested candidates should email or fax their CV to Phyllis Burchman at pburchman@summitdrug.com or (240) 361-9180.
The primary duties of the Vice President, Regulatory Toxicology include the following:
1. Lead the preparation of strategic drug development plans for preclinical pharmacology and toxicology studies supporting a diverse range to therapeutic indications and technologies (e.g. small molecules, biologics, gene therapies).
2. Provide scientific and regulatory direction in preparation of preclinical development plans with knowledge of most recent FDA, EMEA and ICH guidances.
3. Participate in meetings with FDA or other regulatory agencies, defending and negotiating preclinical programs for Summits clients.
4. Provide strategic input into toxicology study designs inclusive of safety pharmacology, genetic toxicology, acute/chronic toxicology studies, reproductive toxicology and carcinogenicity studies.
5. Help draft, as needed, review and edit preclinical sections of pre-IND, IND and other regulatory documents for scientific and regulatory content.
6. Contribute to the identification and acquisition of new clients
Requirements:
Ph.D. degree or equivalent in pharmacology or toxicology from an accredited institution. Minimum of 10 years drug development experience in the biotechnology or pharmaceutical industries. Experience at FDA is a plus. Demonstrated ability and decision making experience with regard to toxicology study designs and in the preparation of preclinical sections of regulatory documents. Successful candidates will have experience in designing preclinical studies for a diversity of product classes and indications and will have experience in interacting with FDA and/or other regulatory agencies. Excellent interpersonal, organizational, writing, oral communication and presentation skills are a must.
Location: This position is located in Summits Rockville, MD office. Full office amenities are provided. Local Candidates Preferred.
Interested candidates should email or fax their CV to Phyllis Burchman at pburchman@summitdrug.com or (240) 361-9180.
My client, a boutique brokerage firm that helps mutual funds and hedge funds do research into various industries, is working on the point of care diagnostics industry. Specifically, he is looking at (IMA) Inverness medical.
He is looking for experts that can discuss any of the following:
1. congestive heart failure testing in hospital, doctors office and home (Inverness bought Biosite in 2007),
2. Opportunities of marrying disease management and diagnostics,
3. M&A opportunities both for IMA and the
industry,
4. IMA's pipeline and
5. IMA's partnership with Proctor and Gamble.
The consulting opportunity would most likely consist of a telephone conference lasting approximately an hour.
If you are interested in this engagement, and are not employed by a publicly traded company, please reply to this email with a bio, some current contact information, a few words about the specific insight you feel you can offer, and your current billing rate.
The consulting firm will present your credentials to our client. If selected, you'll be asked to participate in a telephone consultation for which you will be compensated. Please note that the client will be reviewing other experts and making a selection at least partially based on your hourly phone consultation rate, as well as on relevance of your bio and comments.
Since our client is eager to engage an expert quickly, I'd be grateful if you could respond at your earliest convenience, preferably within 24 hours. KEY things you need to submit are 1. Bio, 2. Brief On-Topic Statement, 3. Billing Rate.
Ed Bertolas
Ed Bertolas Associates Inc
www.ebertolasinc.com
The Center for Professional Innovation and Education is keenly interested in employing ex-FDA personnel as instructors on a contract basis. Currently, they are looking for experts to develop and deliver the following course topics:
Good Tissue Practices (GCP)
Ethical and Regulatory Concerns with Pediatric Clinical Trials
Recent Developments in Organic Synthesis Pharmaceutical Water Systems
Contact Bill Beyer at Email: bbeyer@cfpie.com.
Large pharmaceutical company in Princeton, NJ. Direct all regulatory aspects of assigned projects or project areas across project lifecycle to accomplish filing of regulatory submission (INDs, NDAs, BLAs, 510ks) and facilitate regulatory interactions (e.g. PDUFA product FDA meetings) and regulatory approvals. For marketed products, file regulatory supplements for new indications, labeling, chemistry and manufacturing changes and quality updates and changes and coordinate company activities through approval.
RELATIONSHIPS:
Reports to the designated Senior Director or Director, Regulatory Affairs, Therapeutic Area Head. Works with other personnel in the US Clinical Development, Medical Affairs, Marketing areas and counterparts in NNAS, including global regulatory team and global project team. External relationships include interaction with FDA personnel regarding product/project issues. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives. Acts as an advisor to staff or team members to meet schedules or resolve problems in dealing with the FDA.
ESSENTIAL FUNCTIONS:
COMPANY GOALS
Develop systems and strategies to achieve company goals and ensure regulatory compliance in support of new or modified pharmaceutical products and 510(k) devices or combinations thereof under development or approved.
Direct negotiations and facilitate interactions with regulatory agencies and corporate groups regarding regulatory responsibilities.
Provide for training and dissemination of information as necessary for Regulatory Affairs or other departments.
Ensure that systems are in place for the review of and actions on regulatory related materials.
LEADERSHIP
Develop and implement systems and ensure the best use of resources for the efficient operation of the department.
Act as a catalyst for continuous improvement.
DEVELOPMENT OF PEOPLE
Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.KEY SUCCESS FACTORS:
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
Science degree required; advanced degree strongly preferred; doctorate preferred
Minimum 7 years of hands on related pharmaceutical experience and regulatory drug development experience.
Supervisory management experience required
Experience and knowledge of the current FDA requirements and industry standards.
Excellent verbal and written communication and leadership skills are essential. Ability to establish sound working relationships.
Demonstrated ability to learn new therapeutic areas.
Relocation assistance can be provided. Please call or send me an e-mail and I can give you more details about the position. We also offer a $2,500 bonus if you refer someone and they obtain a position through our services.
Al Gangee
INPHORMER, LLC
inphormer@inphormer.net
www.inphormer.com
267-316-0536
Large pharmaceutical company in Princeton, NJ. Supervise assigned personnel and assist the designated Director of Regulatory Affairs in assuring company compliance with Federal and State regulations and with those of other government agencies, e.g., Customs, USDA, DEA, etc., as our business evolves. Liaison with FDA on key matters. Liaison in inter-company activities, for assigned products or projects. Provide input into the development of regulatory strategies for new or modified pharmaceuticals and devices including the planning of regulatory activities to best utilize resources.
RELATIONSHIPS:
Reports to the designated Director, Therapeutic Area. Works with other personnel in the Medical Affairs, Clinical, Marketing and Legal Departments and counterparts in NNAS Regulatory Affairs. External relationships include interaction with FDA personnel regarding project issues. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives. Acts as an advisor to subordinates or staff members to meet schedules or resolve technical or operational problems.
ESSENTIAL FUNCTIONS:
SUBMISSIONS
Facilitate and organize the compilation of applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications.
Act as liaison departments for preparation of documentation necessary for submission of applications.
Review data from contributing departments and provide comments to assure accurate and complete documents for inclusion in these applications.
PRODUCT DEVELOPMENT SUPPORT
Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products and for 510(k) devices under development or license for assigned projects.
Supervise and coordinate all regulatory activities relating to regulatory compliance for assigned marketed and investigational products.
Supervise and coordinate the planning of FDA submissions for assigned products/projects to ensure most efficient use of resources.
Participate in and/or coordinate all negotiations and interactions with FDA personnel on projects as assigned.
Provide input into development of SOPs for the efficient operation of the department and inter-department activities.
Identify the need for and provide input into development of systems for assigned projects for the efficient operation of the department.
FDA COMPLIANCE
Provide training to the regulatory staff, CRAs and Sales Reps as needed. Provide information and training in areas of IND, NDA, and 501(k) processes. Disseminate information on proposed and new FDA regulations and guidelines for assigned products/projects.
Review all promotional and advertising material and provide regulatory direction for communications to the sales force relating to marketed products for assigned products/projects.
Supervise the review and sign-off on all labeling for marketed products prior to use for assigned products/projects.
DEVELOPMENT OF PEOPLE
Ensure that reporting personnel have forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the development forms are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Contribute to development of Therapeutic Area Associates and Managers.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
Bachelors in Life Science required; advanced degree preferred.Relocation assistance can be provided. Please call or send me an e-mail and I can give you more details about the position. We also offer a $2,500 bonus if you refer someone and they obtain a position through our services.
Al Gangee
INPHORMER, LLC
inphormer@inphormer.net
www.inphormer.com
267-316-0536
Date Posted: 1/7/2008
Job ID: 1598
Company:
We are a biotechnology company that commercializes original instrumentation and services for quickly and broadly conducting high-throughput sequencing. Our sequencer allows one person to prepare and sequence an entire genome. Our technology is commercially available. We offer sequencing services to clients globally. Our technology has enabled numerous peer-reviewed studies in a variety of research fields including drug discovery, infectious disease, cancer research and many more.
Location: Connecticut
Reports To: CEO
Salary: 175-185k
Education: MS or Ph.D. candidates are preferred
Requirements: 5 to 10 years experience leading technology development teams & setting up efficient technology development infrastructures. Must possess a proven track record of success bringing product instrumentation and/or reagents to market. Strong supervisory skills, including interviewing, goal setting, motivation, training, performance appraisal, and corrective action. Knowledge of production planning, processes and control. Knowledge of service level assessment and quality control. Six sigma and ISO 9000 experience preferred. Management of third party vendors. Experience developing budgets and managing expenses to budget. Familiarity with molecular biology and genomics. Good communication skills, both written and verbal.
Duties: Vice President of Manufacturing is responsible for system integration, transfer to manufacturing and quality production of all of company's product lines. This position is responsible directly for approximately 20 people located at the headquarters site, including three Group Leaders. Specific responsibilities include: Meeting customer demand for our products: Determine which products or components should be outsourced; Plan for sufficient manufacturing resources, while maintaining flexibility to respond to variability in demand; Transferring manufacturing processes and QC assays from development into production; Ensure quality of product through appropriate process and quality controls; Establish & maintain reagent stability program; Assist in establishment of customer service levels & achieve specified service levels; Establish & maintain optimal inventory levels for specified service level; Minimize material scrap rate and Increase productivity of manufacturing department. Management of supply chain: Establish & enforce process to qualify suppliers; Negotiate & manage contracts with critical suppliers; Monitor quality processes at suppliers and Establish & implement risk mitigation plans for critical components. Participation in product development process: Ensure products can be manufactured to meet quality and cost goals; Advise on fulfillment logistics; Anticipate impact on supply chain; Participate in design of validation plan for initial product release; Responsible for execution of internal component of validation plan. Build a strong manufacturing organization: Hire & develop department supervisory team, with attention to leadership development & succession planning needs. Establish system for employee training & keep accurate records of such. Maintain good employee morale and effectively resolve difficult situations. Build productive relationships with other departments. Develop and foster a sense of urgency for new product development & production. Operate within budget. Other duties & functions may be assigned to this position as needed.
If sending an updated resume please send in WORD DOC FORMAT.
Andrew Youngelson
Key Recruit Inc.
andrewy@keyrecruit.com
Visit www.keyrecruit.com to view other openings.
Regional Southern Africa FDA/labeling program in the week of April 14, or the week of April 21, in the Johannesburg/Pretoria area. An FDAAA member is sought to outline FDA requirements for FDA-regulated food exported to the US, including practical information on the US regulations, registration of facilities, prior notice, GAP/GMP/HACCP requirements, the import process, typical reasons for product detentions, import alert, etc. The audience would be companies as well as regulatory officials.
This FDAAA speaker will accompany an expert from FDA active staff (if travel approval is granted) who will provide two days of intensive technical FDA labeling training for the food processing companies and one day for one-on-one labeling consultations with the companies.
These activities would be in support of the USG technical assistance effort toward AGOA, with USAID funding for SPS-related technical assistance to Africa.
Please contact Robin Woo at FDA-CFSAN as soon as possible at robin.woo@fda.hhs.gov. FDAAA members who could be alternates for the speaker on labeling are encouraged to reply as well.
Job ID: 1602
Company: Our Company business involves developing, manufacturing, and packaging pharmaceutical products. We manufacture creams, liquids, oils, salves, suppositories, and suspensions of assorted amounts. The company's liquid manufacturing and casing capabilities range from 100 to 1800 gallons. Our current merchandise line is an array of OTC products and controlled legend goods.
Location: Texas
Reports To: President
Salary: 85-110K
Education: 4 Year Degree.
Requirements: Experience filing IND, ANDA, and NDAs who has experience in investigations, internal/external audits, complaints and product development. Communicates and files all ATF, DEA, FDA and Quota documents. Must be a team player, organized, and energetic. Must be willing to travel and advise executive management on compliance/regulatory. Supervisory experience required.
Duties: Oversees recalls and operating procedure changes.
Andrew Youngelson
Key Recruit Inc.
andrewy@keyrecruit.com
Visit www.keyrecruit.com to view other openings.
Successful physician who has had oncology training and been experienced in the pharmaceutical industry for the opportunity of Vice President, Global Therapeutic Head for a major client.
This opportunity has 25 physicians reporting to it and the position reports to the Executive Vice President of Operations Worldwide. We would like a referral that is accustomed to earning 500K plus performance bonuses and other executive perks.
Our client would like a physician who has excellent interpersonal skills and the ability to keep his/her team focused and delivering timely reproducible results. We are seeking a person who can lead by example and has an open door policy.
His/her responsibilities include Phases I-IV and overseeing the DRA department. There are no parallel departments in any of the other Worldwide Divisions.
The successful individual should be American Board Certified in the Subspecialty Board of Oncology and be able to make presentations to peer audiences and very senior management.
We would like an individual who can be comfortable interacting with worldwide customs and traditions. Our client would like a physician who has had interactions with governmental agencies developing INDs and NDAs.
Our client wishes to remain anonymous because there is an incumbent involved.
If you appear to be a possible match, we would discuss your credentials in general terms with our client without identifying your current employment.
If there is continued interest, we will call you and discuss all of the opportunitys requirements and its potential for personal gratification.
After an in-depth interview, we will obtain your permission to release your full C.V. to our client.
The position is located within short distances to all cultural activities and excellent schools.
Joseph G. Stroll
President - J. Stroll Associates, Inc.
980 Post Road East
Westport, CT 06880
0-203-227-3688
email: jstroll1@optonline.net
joe.stroll@gmail.com
http://www.strollassociates.com