*-**-****

RESUME

Sandra Pelus, BS, MS

Medical Writer /Editor /Director/ VP/ President

*** **** ****** ******, *** 401

Shamokin, PA 17872

TEL: 570-***-****; acxmr4@r.postjobfree.com

Professional experience. Sandy Pelus is a medical/scientific writer, editor and program director who works in virtually all fields of clinical medicine and medical research. She has served variously as President, Vice President and Director at medical communication agencies, and has worked for several pharmaceutical companies in the regulatory area. Medical communication agencies and pharmaceutical companies are her principal employers.

■ Regulatory assignments. Sandy’s scientific communications history is extensive. Regulatory document development (NDAs, INDs, adverse reaction reports, protocols, investigator’s brochures, clinical narratives, case summaries) is an important activity.

■ Medical education programs. She is proficient in conceiving and writing journal supplements, monographs, slide-lectures, abstracts, posters, videos, audios, and audiovisual programs. She developed national symposia featuring key opinion leaders that she recruited. Her authors’ polished works (7000 manuscripts) have been published in peer-reviewed medical and scientific journals worldwide. Accredited and promotional programs are represented.

Sandy’s extensive experience includes:

1) ) Regulatory writing-- including adverse reaction reports-- while on staff in the pharmaceutical industry for 17 years: Merck, CIBA-Geigy/Novartis, Lederle.

2) The development from idea to implementation of content for numerous CME-accredited programs on new drugs while at medical educational agencies. Also created non-accredited, marketing-oriented meetings and publications.

3) The responsibility for developing physicians’ manuscripts (numbering 7000) targeted at peer-reviewed research publications; sponsored for 10 years by Merck/Banyu. She achieved a high rate of publication success while overseeing a staff of 35 and operating the company, Clinicom Inc.

4) Creation of medical news reports for publication on computer in Doctor’s Guide; also, in Osteoporosis Today and Essays in Medicine.

5) Sales education programs for pharma sales representatives in various media.

Consultant work at present. Sandy works on a contractual basis with several medical publishers, medical educational agencies, and pharmaceutical companies, among them Pfizer, Purdue, and Novartis; the American Heart Association, Haymarket Medical Publications, Patient Care Publications, Skyscape, and Immunologist.com.

She has acquired and collaborated successfully with many of the nation’s medical opinion leaders and leading CME providers; e.g., the Johns Hopkins School of Medicine, Tufts University School of Medicine, Wisconsin School of Medicine, Cincinnati University School of Medicine, Georgetown University School of Medicine, Jefferson University School of Medicine, and the Mount Sinai School of Medicine.

She manages scientific publications for submission to peer-reviewed journals, and

develops abstracts, posters and oral presentations. Works with authors, clients and supervises the editorial team. Experienced in managing publication plans and overall program activities. She is detailed-oriented, and submits job status and tracking reports. Possesses excellent proofreading, editing and writing skills. Attends medical meetings, writes news reports for GPs and specialists.

Education BS, biology/chemistry (premed), Albright College, Pennsylvania. At Ferkauf Graduate School, New York, she earned an MS in educational psychology, with emphasis on psychometrics and evaluation of depression rating scales. Takes courses in producing video and interactive media, publication design, online video editing, medical writing and editing, as well as medical statistics and clinical pharmacology.

Summary

Develops proposals and educational programs. Works from initial outline to the final product, emphasizing content that is accurate, clear, balanced, and relevant to practicing physicians, surgeons. Sales representatives are a prime audience for educational materials on new drugs.

Interprets clinical data and presents it appropriately with Figures and Tables.

Presents information in print, audiovisual, “live,” interactive, and online formats.

Performs medical/scientific editing, research, and fact-checking.

● Mentors and supervises medical

writers.

Medical expertise Includes areas such as oncology, hematology, cardiovascular diseases, neurology, psychiatric disorders (schizophrenia and bipolar syndrome), allergic diseases, asthma, COPD, dermatologic disorders, osteoporosis, infectious diseases, renal diseases, rheumatology, gastroenterology, diabetes, painful disorders (arthritis, migraine, fibromyalgia) and clinical pharmacology. Also, covers issues in primary care, as well as in clinical and basic research on new drugs, emergency medicine, surgery, anesthesiology, epidemiology, genetics, and the healthcare environment.

STAFF POSITIONS

Pharmaceutical Staff

Sandy has worked as a medical writer/director, information specialist, and adverse reactions director for regulatory submissions in the pharmaceutical industry, including Merck, Lederle and CIBA-Geigy (Novartis). She also supervised data processing on antibiotics and developed a medical abstract service for staff physicians.

■ Regulatory Work

While employed at CIBA-Geigy, Sandy wrote a variety of regulatory documents:

Adverse reactions developed retrieval system; detailed analysis and reports

NDA master summaries

IND reports

Clinical investigator brochures

Clinical study reports

Drug reports

Clinical narratives

Protocols

Prescribing information for patients

Adverse Reactions Director-- CIBA-Geigy (Novartis)

Sandy directed the Adverse Reactions Department at CIBA-Geigy (Novartis) for 8 years, where she evaluated, summarized, and reported to the FDA on adverse reactions to Geigy drugs. Some of the alleged reactions involved serious, even fatal, events such as aplastic anemia and leukemia that occurred on potent anti-inflammatory drugs. Cases of suicide on antianxiety agents were another major concern. Other reactions were milder (but reportable to the FDA) such as diarrhea following a laxative.

To identify any related cases, she conducted in-depth searches in the world literature, as well as Company files in the U.S. and Europe. Sandy consulted with staff physicians and summarized the causal relationship between the Geigy drug and the other possible contributory factors such as a coexistent disorder, concomitant medications, familial, drug misuse and other factors.

Sandy’s reports were part of the documentation of the safety of an agent, as well as its toxicity. These reports were submitted to the FDA, and the Prescribing Information was reviewed and revised as needed.

In a related effort, she wrote the section on treatment of overdosage of Geigy drugs that was distributed to poison control centers.

Sandy’s work required consultation and collaboration with Geigy physicians such as Edgar Flint, MD, Edward McKeon, MD, and Vice President Harold Hailman, MD, PhD.

Medical Communications Staff

President and Executive Scientific Director, Clinicom Inc, New Jersey (Jan 1990-Dec 2000). Sandy directed a staff of 35 medical and scientific writers/editors in providing medical/scientific writing and editorial services for medical researchers and clinicians. During this intensive 10-year program, She oversaw the editing, writing and rewriting of nearly 7000 clinical and research-oriented manuscripts which were published in peer-reviewed journals. They variously covered oncology, diabetes, schizophrenia, infectious disease, pulmonary disease, allergic disease, neurologic disorders, painful conditions such as migraine, fibromyalgia and arthritis, as well as many other disease categories.

Program success was acknowledged by a high publication acceptance rate, with contract renewals and by the authors’ acknowledgements. Sandy maintained contact with program sponsors and negotiated with publishers. Contracts were completed in 2000. Sponsored by Merck /Banyu and other companies.

Vice President, Director of Communications, AVMD, New York. (Oct 1986-Jan 1990) Sandy developed original content for more than 300 CME-accredited, live medical symposia, publication programs, and related educational materials. Acquired academically-based physicians as speakers, authors, and content advisors. Collaborated with medical advisory boards and CME providers at leading medical schools to develop content for audiovisual and print programs. Developed and presented proposals for numerous new educational initiatives. Oversaw the editorial effort. Maintained contact with program sponsors.

Managing Medical Editor, Adelphi Inc (Medical Communications), New York. (Nov 2000-March 2003) Sandy acquired notable physician-authors, negotiated content and CME review; and edited medical manuscripts for publication in peer-reviewed journals. Originated new business proposals and novel publications. Developed/ managed/ wrote/edited “Osteoporosis Today,” a highly successful medical newsletter; a CME accredited program on osteoarthritis; an abstract book on osteoarthritis. She oversaw the publication of a CME-accredited journal supplement on H1 inhibitors (American Journal of Medicine). Established content for new CME programs and medical publications. Negotiated with CME program sponsors such as the University of Wisconsin and UMDNJ.

Director, Medical Writing, MED Communications, New Jersey. (1978-1986) For pharmaceutical sales representatives, Sandy developed/ illustrated/ wrote educational programs using interactive formats to probe and explain the basics of cancer, viral

infections, wound care, antibiotics/antibiotic resistance, immunity and the compromised patient, chest drainage systems, antiviral agents, the interferons, and AIDS, among other topics. Scientific data were provided by program sponsors including Johnson & Johnson, Merck, Pfizer, and BMS.

Memberships: American Medical Writers Association; Council of Biology Editors; Drug Information Association (not current); Mediabistro; American Association of Healthcare Journalists.

FREELANCE / CONSULTANT EXPERIENCE (2003-2016)-2016

Sandy currently works on contract and as a consultant with companies such as these:

Hillside Medical Communications, PA. 2003 to date. (This is Sandy’s company.)

Sponsoring companies include Pfizer, Purdue, Novartis; Patient Care Publications, Advanstar, American Heart Association, Doctors Guide, Haymarket Medical Communications (See below.)

She develops brochures on new drugs, as well as manuscripts intended for publication in peer-reviewed medical journals covering disorders such as hypertension, hypercholesterolemia, cancer, thyroid disease, diabetes, COPD, transplantation issues, fibromyalgia, arthritis, and bipolar disease.

Pfizer (through Haymarket Medical Communications, NYC)

Hypertension management update; wrote monograph accredited for CME by

Mount Sinai School of Medicine.

Hypercholesterolemia management update--atorvastatin; wrote monograph

accredited for CME by Mount Sinai School of Medicine.

Bipolar disease therapy, an illustrated manuscript

Doctors Guide-- computer site, NYC

Covered major medical conventions and summarized presentations that were quickly

published online. Topics included new drugs for diabetes, infectious diseases, lupus,

stroke and CNS diseases.

Patient Care a medical journal published by Advanstar Publications.

Sandy Pelus’ bylined articles include (CME-accredited by Patient Care):

Antibiotic-resistant infections

Fibromyalgia diagnosis and management

Earlier cancer diagnosis

Management of breast cancer

Management of prostate cancer

Migraine therapy (cover feature)

Treatment of infectious diseases

Purdue Pharma (Ct)

For Purdue Pharma, Sandy wrote clinical manuscripts on chronic pain management

in osteoarthritis with a topically applied opioid.

Novartis (Icon Nicolson Interactive Medical Programs, NYC)

For Novartis, she wrote a 3-part computer program on antiangiogenic agents for

treating colorectal cancer including Avastin and a new chemotherapeutic drug.

Directed audiotaping of this program by physician participants. Accredited by the

Johns

Hopkins University School of Medicine.

American Heart Association, TX

Sandy wrote “Worrying for Two,” an original article published in the AHA journal.

This publication presents the challenges facing caregivers for heart transplant

recipients. Five patients and their caregivers are featured.

MEDICAL COMMUNICATIONS STAFF EXPERIENCE

Sandy has worked as a medical writer/director, information specialist, and adverse reactions director for regulatory submissions in the pharmaceutical industry, including Merck, Lederle and CIBA-Geigy (Novartis). Supervised data processing and reporting of clinical trial information. Developed an abstract service for physicians.

Sandy served as President and Communications Director of Clinicom, a medical publications service company (10 years); as managing medical editor at Adelphi (3 years); as Vice President/Creative Director of AVMD, a CME-accredited symposia/meetings organization (3 years); and as Director of Medical Writing at MED and at MEDCOM (10 years).

--- These regulatory materials were developed for the FDA while on staff at pharma companies:

Adverse reactions retrieval system; detailed analysis and reports

NDA master summaries

IND reports

Clinical investigator brochures

Clinical study reports

Drug reports

Clinical narratives

Protocols

Prescribing information for patients

--- These programs were developed while on staff at medical communication agencies:

● Programs/Publications for Physicians

Angiogenesis and colorectal cancer--interactive computer-based program for oncologists;

CME-accredited by Johns Hopkins University School of Medicine

Hypertension management update (monograph CME-accredited)

Hypertension today (meetings and slides)

Osteoporosis overview (newsletter series and numerous CME programs with slides)

Osteoporosis scientific presentation book

Cholesterol-lowering guidelines (monograph CME-accredited)

Peptic ulcer management (about 300 meetings plus monographs and slide lectures)

Claforan (antibiotic) (monograph/module for physicians)

COPD therapy current recommendations (slide lecture program)

Dealing with bacterial infections (CME-accredited)

Early signs of cancer (CME-accredited)

Wound care brochure featuring illustrated application of dressings

Treatment of male infertility

Treatment of schizophrenia and bipolar syndrome

Clinical manuscripts-- including work on an opioid applied topically for pain relief

Monograph on pit and fissure sealants in dentistry (Johnson & Johnson)

At Clinicom Inc, she conducted the editorial management of 7000 medical research publications for physicians.

● Educational Programs for Sales Representatives (Illustrated print with audiotapes)

The surgeon (1 module)

The microbiologist (1 module)

The interferons in health and disease (6 modules)

Understanding cancer (3 modules)

HIV diagnosis and treatment (2 modules)

The compromised patient (2 modules)

Viral infections (3 modules)

Pulmonary drainage systems (3 modules)

Anticoagulation during surgery (2 modules)

Anaerobic infections and their treatment (7 modules)

Insulin pumps and their use

Chest drainage systems and their applications.

Contacts/References

These individuals assigned, supervised and/or approved my work.

They can be contacted via the professional web site, Linkedin:

--Dean Karalis, MD (Edited/rewrote his monograph on hypercholesterolemia)

Professor, Drexel University

Philadelphia, PA

--Ellen Ingber (Contact for my manuscripts on opioids developed for publication)

Executive Director, Scientific Communications

Purdue Pharmaceuticals

Stamford, Connecticut

--Dean Beals (Contact for my Johns Hopkins CME program on colorectal cancer

developed for physicians)

CEO, DB Medical Communications Agency

New York, New York

-- Peter D'Epiro, PhD (Editor for my manuscripts on various forms of cancer, as

well as migraine and fibromyalgia, written for Patient Care, a journal for

physicians)

Patient Care (publication now closed)

Ridgewood, New Jersey

-- Editors, Haymarket Medical Communications (Assigned /reviewed manuscripts

written by me for publication in brochures on hypertension and

cholesterol-lowering agents)

New York, New York

Contact this candidate