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I have strong research and writing skills, as well as excellent analytic abilities. I get along well with co-workers and enjoy collaboration on projects. I am competent in using all Microsoft programs, including Excel and PowerPoint.
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Senior Market AnalystDecision Resources, Inc. May 1997 - Jul 2010Waltham, MassachusettsProduced reports for Decision Resources’ DecisionBase product line. This family of reports provides quantitative and qualitative comparisons of the financial and clinical opportunities presented by various diseases. Producing reports required interpretation and comparison of clinical trial data, country-specific epidemiology trends, local treatment practices, and market forecasts. Diseases covered included rheumatoid arthritis, type 2 diabetes, psoriasis, hyperlipidemia, depression, and restenosis. (Worked for U.K.-based company in 2002 before returning to Decision Resources.)Managed several portfolios in this international pharmaceutical advisory firm’s Spectrum Life Sciences line of reports. Duties included ascertaining topics of strategic importance to the pharmaceutical industry, identifying and contracting with experts to draft reports, assisting in developing report content, and making revisions in accordance with the company’s standards. Provided guidance to other Decision Resources staff members on regulatory issues. -
Senior Regulatory Affairs SpecialistMedisense Products Aug 2003 - Mar 2004Burlington, MassachusettsPrepared regulatory filings for this developer and manufacturer of blood glucose monitors and test strips. Worked with product development teams to ensure that proper data was generated to support regulatory filings. Provided guidance on labeling, marketing practices, and development of regulatory plans. Performed device modification analyses in accordance with FDA regulations and related Guidance Documents. (Abbott Lab’s acquisition of competitor TheraSense resulted in 2004 closure of all Massachusetts MediSense facilities.)
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Analyst, Immune Disorders And InflammationDatamonitor Healthcare Jan 2002 - Sep 2002London, United KingdomFull P&L and operational responsibility for business unit that drafted reports assessing commercial opportunities in the treatment of immune-related diseases. Reports included sections on SWOT analysis of marketed drugs, patent expiry/market exclusivity, lifecycle management, and assessment of pipeline compounds. Position required frequent client contact and close working relationships with sales, marketing, and consulting divisions. (Company reorganization resulted in termination of position.) -
Regulatory CounselU.S. Food And Drug Administration, Office Of Device Evaluation May 1995 - Jun 1996Gaithersburg, MarylandCounseled medical device manufacturers and clinical investigators regarding their legal obligations under FDA regulations governing the conduct of clinical investigations (21 CFR Parts 50, 56, 812). Provided assistance on such matters as emergency use of investigational devices, studies exempted from regulatory oversight, and questions concerning significant versus nonsignificant risk device studies. Drafted Guidance Documents for the benefit of the Office of Device Evaluation’s reviewing divisions and the device industry. Topics included custom device exemption and treatment IDEs. Drafted final regulation on Humanitarian Use Devices (i.e., devices exempted from the effectiveness requirement of the FD&C Act).
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Regulatory Counsel, Office Of Health Affairs, Office Of The CommissionerU.S. Food And Drug Administration Aug 1991 - May 1995Rockville, MarylandProvided staff support to the Associate Commissioner for Health Affairs on a wide range of regulatory matters, including international harmonization of rules governing good clinical practices, disqualification of clinical investigators, and international treaty on biological weapons inspections. Responded to inquiries from study sponsors, investigators, and institutional review boards (IRBs) pertaining to agency and departmental regulations. Assisted in fulfilling FDA’s responsibilities under Title II of the Drug Price Competition and Patent Term Restoration Act of 1984. Served as the Executive Director of FDA’s Research Involving Human Subjects Committee. Participated in the development of numerous regulations, including obtaining informed consent in emergency medical settings and financial conflicts of interest of clinical investigators.
John Ensign Education Details
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Doctor Of Law - Jd
Frequently Asked Questions about John Ensign
What is John Ensign's role at the current company?
John Ensign's current role is Healthcare Writer, Market Analyst, Attorney.
What is John Ensign's email address?
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What is John Ensign's direct phone number?
John Ensign's direct phone number is +197842*****
What schools did John Ensign attend?
John Ensign attended University Of North Carolina At Chapel Hill, New England Law | Boston, Brandeis University.
What are some of John Ensign's interests?
John Ensign has interest in Exercise, Investing, Electronics, Reading, Sports.
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John Ensign
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John-Paul Ensign
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2gmail.com, bocaparkanimalhospital.com2 +170267XXXXX
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1rocket.com
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