Clinical Evaluation Report (CER) Medical Writer

Perform Clinical Evaluations and write/update Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs)  in compliance with the European Union (EU) Medical Device Regulation (MDR).  Perform Literature Review using PubMed, Embase, Cochrane Library, and similar databases. Interpret the current, new, and changing requirements for clinical research—including heightened restrictions on product equivalency—to ensure the proper clinical information about the device is available for use within the company.  Contribute to successful transfers of research results into the MDR-compliant CER.

  • Work with all interested parties to ensure that the clinical evaluation (per MDR) is conducted including clinical testing of all indications/changes in a timely manner to meet feasibility goals and all regulatory deadlines.
  • Ensure sites provide adequate ongoing clinical recruitment and submission of data to client and provide tabular data to regulatory as the basis of clinical reports.
  • Support scientific abstract submission and use clinical data as the basis for preparation of presentations.
  • Advise colleagues in R&D department on new technical and clinical developments.
  • Work closely with cross-functional teams to interpret device performance information in clinical settings and in patient use.
  • Perform research as needed to provide applicable information about new technology in Diagnostic Imaging
  • Participate in Human Factors / Usability Testing by 3rd party providers, develop protocols, train engineers, and observe testing
  • Identify issues that need resolution to ensure safety and effectiveness of the products.
  • Coordinate, prepare, and execute premarket applications to the US FDA including Premarket Notification [510(k)], Pre-Sub, IDE, PMA, and De Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions.
  • Assess necessity for submitting a 510(k) application for proposed device modifications. Prepare robust non-filing justifications for changes that do not require a 510(k) submission.
  • Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).
  • Represent Clinical Affairs and demonstrate leadership in complex product development teams by identifying and interpreting relevant clinical regulatory requirements and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.
  • Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to stakeholders.
  • Lead clinical evaluation efforts required to comply with new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.
  • Review and approve product labeling, promotional materials, and advertising materials to ensure consistency with the Clinical Evaluation Report.
  • Review clinical and human factors protocols/reports to assure collection of appropriate data for regulatory submissions and regulatory compliance. Engage with Medical Affairs in the development and approval of Clinical Evaluation Report to assure the documents meet regulatory requirements.
  • Ensures FDA device listings and facility registrations are maintained.
  • Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
  • Coordinate and respond to requests for product information, and questionnaires requested by customers.
  • Remain current on regulations affecting medical device products (EU MDR/IVDR, reclassification activities, etc.) and keep the relevant team and supervisors informed about potential impact.
  • Identify ways to improve the efficiency of current work process and execute them.
  • Carry out the above tasks without supervision.
  • Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment
  • Interest in and passion for research, bringing medical innovations to market and working in multidisciplinary teams
  • Good communication skills, written and verbal
  • Available to travel domestically approximately 25%, with occasional international travel.

Combining Research, Safety, and Epidemiology

Risk Management Consulting (RMC), a health services research firm, offers Research, Safety, and Epidemiology services with experience in the healthcare consulting and biopharmaceutical industries. RMC provides the health care system, biopharmaceutical industry, academia, and the Federal Government with “real-world” data to improve the quality, safety, and affordability of healthcare. RMC’s projects range from retrospective to large-scale, prospective studies in the areas of drug, vaccine, and medical device safety surveillance, risk management, pharmacoepidemiology, health outcomes, pharmacoeconomics, and comparative effectiveness research.


Lead the business operations of the Safety and Epidemiology business unit and oversee a team of scientists in the execution of pharmacoepidemiology, risk management, and medical product safety studies for a portfolio of clients in the biopharmaceutical industry. 
  • Business operations management
    • Set the strategic direction and priorities for the Safety and Epidemiology business unit.
    • Plan, direct, and control the resources and efforts of the Safety and Epidemiology business unit, including the development and implementation of the hiring plan.
    • Mentor and develop associates to support the growth and success of Safety and Epidemiology team.
    • Lead analysis for resources (e.g., people, funding, materials, and support) to complete projects and recommend changes.
    • Lead the evaluation of business unit performance against plan to review successes, shortfalls, and areas of concern.
  • Research portfolio management
    • Operational accountability of all Safety and Epidemiology projects.
    • Support principal investigators and project managers in the proactive identification of potential bottlenecks, gaps, and risk areas as it relates to scope, budget, and timeline, and escalation to senior leadership.
    • Track current and projected financial status of research projects.
    • Support research leads in the development of timely, accurate, and high quality project deliverables.
  • Business development support
    • Lead the development of study proposals in response to a Request for Proposal, including the scope of work, budget, and timeline framework around each proposal.
    • Work collaboratively with Business Development Directors to facilitate proposal submission, bid defense preparations, and contract execution.

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CMS Shared Savings Program


The Affordable Care Act (ACA) included provisions to expand value-based purchasing; broaden quality reporting; improve the level of performance feedback available to providers; and create incentives to enhance quality, improve beneficiary outcomes, and increase the value of care. Confidential physician feedback reporting was initially implemented under Section 131 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) and later expanded by section 3003 of the Affordable Care Act of 2010 (ACA). MIPPA and subsequently ACA, directed the Centers for Medicare & Medicaid Services (CMS) to provide confidential information to physicians and medical practice groups about the resource use and quality of care they provide to their Medicare patients, including quantification and comparisons of patterns of resource use/cost among physicians and medical practice groups. In addition to the expansion of Physician Feedback reporting, section 3007 of the Affordable Care Act also required CMS to begin applying a value-based payment modifier under the Medicare Physician Fee Schedule (PFS) in 2015. CMS has incorporated these requirements, set forth in legislation, into its Physician Value initiatives, which incorporate the Physician Feedback and Value-Based Modifier Programs. These programs are part of CMS’ aim to transform Medicare from a passive payer role to that of an active purchaser of higher quality, more efficient health care.


Section 3022 of ACA added Section 1899 to Title XVIII of the Social Security Act and required the Secretary to establish the Medicare Shared Savings Program (Shared Savings Program), with the intention of the development of Accountable Care Organizations (ACOs) in Medicare. The Shared Savings Program was implemented in January 2012 to help doctors, hospitals, and other health care provides better coordinate care for Medicare patients through ACOs. By focusing on the needs of patients and linking payment rewards to outcomes, this leading ACA delivery system reform will help improve the health of individuals and communities while lowering the growth in Medicare costs. CMS published two proposals to strengthen the Shared Savings Program and finalized the proposals in the June 9, 2015 and June 10, 2016 Federal Registers.


Currently, we are proposing policies in the CY2017 PFS to align the Medicare Shared Savings Program with the proposals for the Quality Payment Program, to take beneficiary preferences for ACO assignment into consideration, and to improve beneficiary protections when ACOs are approved to use the skilled nursing (SNF) 3-day waiver rule. We also are proposing to refine and further implement the value-based payment modifier. To do so, we need to assess and analyze current policy options and proposed rule comments to finalize the regulation.

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The State of Cancer Research

DHT Image“Most current research is a waste of time and money. It is magic bullet nonsense. Take the search for the cancer gene. Are there genes that give one a predisposition for getting cancer? Absolutely. This is exactly what the Baseline of Health talks about when it refers to your Personal Health Line at the time of birth.

But looking for a cancer cure by finding the cancer gene will do nothing to eliminate all of the other factors responsible for cancer. And we already know how small a role the cancer gene plays in the onset of cancer: there has been an 8-fold to 17-fold increase in the incidence of cancer in the last hundred years, but not even one-millionth of 1 percent of that increase can be related to genes.

Genes evolve over hundreds of thousands (if not millions) of years, which means that the so-called cancer gene has had no impact on the huge increase we’ve seen since 1900. Virtually 90 percent of the cancer that we see today cannot possibly have anything to do with genes. So, at best, genes are responsible for only a small percentage of the minimal cancer rates we had in the early 1900s, and finding the cancer gene will affect only that tiny percentage of cancer. Genes may create tendencies, but in most cases they are not the underlying cause. Bottom line: look not for a cure in the cancer gene.

There is, however, a ray of hope in the world of medical research. In the last few years, medical research has started committing resources to the development of methods to harness and enhance the body’s natural tendency to defend itself against malignant tumors. Immunotherapy represents a new and powerful weapon in the arsenal of anticancer treatments. Sometimes referred to as biological response modifiers or as biological therapies, these new treatments–such as interferons and other cytokines, monoclonal antibodies, and vaccine therapies–have generated renewed interest and research activity in immunology.”

From Jon Barron of

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Declining incidence of major diseases: heart disease, hip fractures, colon cancer, etc.

“Screening, they say, is only part of the story. “The magnitude of the changes alone suggests that other factors must be involved,” they wrote. None of the studies showing the effect of increased screening for colon cancer have indicated a 50 percent reduction in mortality, they wrote, “nor have trials for screening for any type of cancer.”

Then there are hip fractures, whose rates have been dropping by 15 to 20 percent a decade over the past 30 years. Although the change occurred when there were drugs to slow bone loss in people with osteoporosis, too few patients took them to account for the effect — for instance, fewer than 10 percent of women over 65 take the drugs.

Perhaps it is because people have gotten fatter? Heavier people have stronger bones.

Heavier bodies, though, can account for at most half of the effect, said Dr. Steven R. Cummings of the California Pacific Medical Center Research Institute and the University of California at San Francisco. When asked what else was at play, he laughed and said, “I don’t know.”

Dementia rates, too, have been plunging. It took a few reports and more than a decade before many people believed it, but data from the United States and Europe are becoming hard to wave off. The latest report finds a 20 percent decline in dementia incidence per decade, starting in 1977.

A recent American study, for example, reports that the incidence among people over age 60 was 3.6 per 100 in the years 1986-1991, but in the years 2004-2008 it had fallen to 2.0 per 100 over age 60. With more older people in the population every year, there may be more cases in total, but an individual’s chance of getting dementia has gotten lower and lower.

There are reasons that make sense. Ministrokes result from vascular disease and can cause dementia, and cardiovascular risk factors are also risk factors for Alzheimer’s disease. So the improved control of blood pressure and cholesterol levels should have an effect. Better education has also been linked to a lower risk of Alzheimer’s disease, although it is not known why. But the full explanation for the declining rates is anyone’s guess. And the future of this trend remains a contested unknown.

The exemplar for declining rates is heart disease. Its death rate has been falling for so long — more than half a century — that it’s no longer news. The news now is that the rate of decline seems to have slowed recently, although it is still falling. While heart disease is still the leading cause of death in the United States, killing more than 600,000 people a year, deaths have fallen 70 percent from their peak. The usual suspects: Better treatment, better prevention with drugs like statins and drugs for blood pressure, and less smoking, are, of course, helping drive the trend. But they are not enough, heart researchers say, to account fully for the decades-long decline.

The heart disease effect has been examined by scientist after scientist. Was it a result of better prevention, treatment, lifestyle changes?

All three played a role, researchers said.”