80 W. North St. Bethlehem, PA 18018
firstname.lastname@example.org (267) 981-6446
· BS in Biology, MS in Biomedical Writing, and Certified Medical Publication Professional (CMPP)
· Broad and deep experience in medical publications and communications
· Proficiency in scientific direction, promotional communications, scientific communications platforms, publication planning, CME, regulatory writing, and public relations for R&D
· Knowledge and understanding of the drug development process
· Develop strategic regulatory, promotional, and publication plans for clinical and outcomes data
· Expertise in following International Committee of Medical Journal Editors (ICJME) guidelines, Good Publication Practices (GPP), International Committee on Harmonization (ICH) guidelines, and standard operating procedures (SOPs)
· Coordinate timelines, including the review of projects with internal and external stakeholders
· Foster and maintain relationships with medical/scientific/ trade journal editors, freelancers, and journalists
· Maintain status reports and in-house bibliographic databases (EndNote)
· Develop pitches, proposals, and budgets as well as negotiate contracts with clients and for vendor services
· Proficient in MS Office, MS Project, and publications planning tools (e.g., Datavision)
· Work in matrix teams interacting with external (key opinion leaders, investigators, clinicians) and internal (medical directors, statisticians, outcomes) team members
· Direct and manage teams of writers, editors, and freelancers
Therapeutic Area Experience
Oncology/hematology: fosbretabulin, sunitinib, crizotinib, docetaxel, liposomal doxorubicin, trabectedin, napabucasin, galeterone, oprelvekin, gemtuzumab ozogamicin
Immunology/rheumatology/dermatology: etanercept, infliximab, alefacept
Cardiovascular: droxidopa, ezetimibe/simvastatin, pravastatin, irbesartan, amiodarone
Metabolic/obesity: sitagliptan, pramlintide acetate, Slimfast - meal replacement therapy
Infectious diseases/HIV: ertapenem, raltegravir, telithromycin, fluconazole
Urology/nephrology/anemia: alfuzosin, leuprorelin, epoetin alfa
CNS: droxidopa, venlafaxine, modafinil, zaleplon
Link Health Group Bethlehem, PA/Bridgewater, NJ
Scientific Director Aug. 2015-April 2018
For biotech/pharma company clients, directed the development and implementation of communications strategies including medical science liaison training, scientific communications platforms, promotional medical communications, and publications plans for agents used in oncology and cardiovascular/neurology. Also, provided scientific direction and medical writing services for medical congress activities, as well as for regional, national, and international advisory board meetings. Oversaw content development by a small home-based team of medical writers and freelance editors.
Freelance Medical Writer Bethlehem, PA
Freelance Jan. 2014-Dec. 2014
Provided consultancy services, project management, and implementation of medical/scientific communications and regulatory writing projects (including protocols, CSRs, and other regulatory documents).
ICON Clinical Research North Wales, PA
Associate Director, Medical Writing Sep. 2011-Feb. 2013
Managed a team of home- and office-based medical writers and editors within the US Medical Writing Department. Provided direction for regulatory writing and publication services. Promoted ICON medical writing business and directed teams in the writing, editing, and compilation of regulatory documentation for biologics and small molecule agents primarily in vaccines (Prevnar), oncology (crizotinib), and anti-inflammatory (tofacitinib) therapeutic areas. Wrote/edited clinical study reports, protocols, and briefing documents, including interpretation of clinical/statistical data. Performed manager-level quality control and peer review of all deliverables to assess compliance with regulatory requirements, client requests, and ICON or sponsor SOPs. Established processes and procedures to ensure deliverables met all requirements as well as negotiated timelines. Assisted Business Development with the preparation of proposals and cost estimates for medical writing tasks. Participated in client/sponsor review meetings. Tracked staff hours/resources, timelines, and budgets for assigned projects. Through departmental meetings, one-on-one meetings, mentoring, and periodic performance evaluations; effectively managed up to 7 US-based departmental staff.
Ashfield Healthcare Communications ACUMED, New York, NY
Scientific Director Sep. 2010-June 2011
Provided strategic scientific direction for scientific platforms and publication plans, including proposals of target journals and medical congresses for publication/presentation of clinical, pharmacokinetic, and outcomes data. Publication plans were for solid-tumor therapeutics including sunitinib (Sutent, pancreatic neuroendocrine tumor indication) and crizotinib (Xalcori, an ALK kinase inhibitor for non-small cell lung cancer). Worked directly with investigators and client-side scientists, statisticians, and outcomes researchers to implement plans by writing, editing, and critically reviewing and editing scientifically rigorous manuscripts, abstracts, posters, and presentations. Created secondary communications including Web video interviews with clinician authors and training slide repositories used by medical science liaisons (MSLs). Led weekly publications status meetings, as well as monthly Publication Sub-Committee (PSC) meetings with clients.
Janssen Biotech J&J (formerly Ortho Biotech), Raritan, NJ & Horsham, PA
Lead, Medical Affairs Publications Feb. 2008-Sep. 2010
Using pivotal analyses, secondary, and meta-analyses of clinical data and health economic outcomes studies, drove global publications plans for oncology therapeutics, Doxil and Yondelis, and for anemia of chronic kidney disease (CKD) and anemia in long-term care (LTC) indications for Procrit. Through a combination of vendor management and in-house writing and editing, developed manuscripts, abstracts, posters, and slide presentations. Led publications steering committee meetings with matrix teams and maintained effective working relationships with external experts, investigators, and key clinical leaders. Actively participated and presented at advisory board meetings. Served as publication leader for oncology and LTC/anemia publication plans, which included managing budgets, directing external vendors, summarizing weekly plan status, and communicating key publications to internal stakeholders and external audiences. Increased Doxil and Procrit-nephrology publications year-over-year with very limited budgets. Yearly plans entailed managing 20+ manuscripts across all products and a similar number of abstracts and posters concurrently, demonstrating the ability to multi-task and operate effectively across several therapeutic areas.
Merck & Co., Inc. Merck Research Laboratories, North Wales, PA
Senior Medical Writer / Medical Publications Lead Nov. 2006-Feb. 2008
Working as part of an in-house publication writing group, developed and implemented publication plans (yearly wrote ~10 manuscripts and ~15+ abstracts/posters) for products in cardiovascular/metabolic (Vytorin) and infectious diseases (Invanz, Isentress) therapeutic areas. Worked internally with matrix teams, and externally with clinical investigators to write compelling content for publications, abstracts, posters, and presentations. Participated in investigator meetings and on multidisciplinary clinical trial monitoring meetings involving medical affairs, biostatistics, regulatory, and global clinical operations to plan for publications as data became available. As publications lead for Invanz, oversaw the implementation of the global publication plan.
Sanofi (formerly Aventis and Sanofi-Aventis), Bridgewater, NJ Aug. 2002-Nov. 2006
Manager, U.S. Scientific Publications U.S. Medical Affairs, Sanofi-Aventis
Jan. 2004-Nov. 2006: Developed publication plans for urology/oncology (Uroxatral, Eligard, Taxotere-prostate cancer indication) portfolio of products and also for two patient registries (~7000 men with benign prostate hyperplasia [BPH] and ~2500 men with prostate cancer). Developed plans and content with input from internal matrix teams and external key medical leaders and investigators. Oversaw all aspects of publication plans including managing vendors, interacting with authors, negotiating vendor budgets (in millions), writing/editing and critically reviewing content, and maintaining timelines and status reports. Also used Journal Selector and GoPubMed to aid in identifying appropriate target journals for manuscripts and developed trackers to inform the team of specifics of upcoming congresses for abstract submission (i.e., timelines, submission procedures, encore acceptances, etc.). In addition to publication planning duties, collaboratively wrote CSR for a phase 4 study of Uroxatral and oversaw CME grants for enduring CME activities.
Manager, Science & Technology Communications Global R&D, Aventis
Aug. 2002-Jan. 2004: For Global R&D within Aventis, managed scientific media and public relations, industry publication interactions, and internal R&D communications. Oversaw scientific and trade publication tactics, external presentations at trade meetings (BIO meeting), and media/trade publication interviews across multiple R&D sites in the U.S. (Cambridge, Bridgewater, Tucson). Cultivated and maintained relationships with scientific trade journal editors and facilitated interviews of scientists and management. Collaborated with scientists and management on bylined articles and industry presentations. With a limited budget, increased year-over-year coverage of R&D within industry and trade outlets.
Wyeth (now Pfizer), Collegeville, PA
Senior Medical Writer, Professional Education Support July 2001-Aug. 2002
As part of an internal medical education/communications group, planned and implemented strategic peer-reviewed publications, CME, and sales communications and training. Wrote content for traditional print (peer-reviewed publications, abstracts, posters, CME content, sales training, backgrounders, etc.) and Web-based communications. Therapeutic areas included rheumatology/dermatology (Enbrel global brand team), oncology (Mylotarg and Neumega U.S. brand teams), and CNS (Effexor).
Precept Medical Communications Division of Sudler&Hennessey, Short Hills, NJ
Senior Medical Writer Jan. 2001-July 2001
Executed project-based medical communications and CME programs. Examples included: a 22-article journal supplement on obesity and meal replacement therapy (SlimFast); for a biotech psoriasis agent (Amevive) developed a satellite symposium (syllabus and slide presentations) and wrote patient-focused articles published in the National Psoriasis Foundation newsletter; for an antibiotic (Avelox) developed publications; and for a GI product (Pentasa) developed interactive Web-based sales training.
Medical Education Group EuroRSCG Life (now HAVAS Life/Health), Neshaminy, PA
Senior Medical Writer April 2000-Dec. 2000
Developed and executed an international (non-US) communications plan for a global rheumatoid arthritis brand team (Enbrel), entailing educational symposia and publications for European meetings and journals, along with Web-based components. All content was developed modularly to facilitate translation and repurposing by international affiliates. The company is no longer in business.
Advanced Clinical Communications (company no longer in business), Lambertville, NJ
Senior Medical Writer & Digital Media Manager Aug. 1998-Mar. 2000
Implemented publications, scientific communication deliverables, and medical education programs for a variety of therapeutic areas with a focus on CNS/Sleep (Sonata, Provigil), infectious diseases (Trovan, Diflucan), and metabolic (Pravachol). Plans entailed traditional print publications, audio, video, and digital/Web components. The company is no longer in business.
Oxford Clinical Communication (OCC), Inc. (company no longer in business), Newtown, PA
Scientific Writer Dec. 1996-Aug. 1998
Wrote content of slides, abstracts, posters, manuscripts, product/disease monographs, visual aids, and other custom scientific media to fulfill promotional and educational communication plans for a hypertension agent (Avapro), a topical steroid (Cutivate), and a biologic agent (Remicade). The company is no longer in business.
SmithKline Beecham (now GlaxoSmithKline), Collegeville, PA
Regulatory Document Associate (contract) June 1996-Dec. 1996
On contract assignment, worked in the regulatory affairs archives, abstracting and cataloging regulatory documents including New Drug Applications (NDA) and Investigational New Drug Applications (IND).
General Accident Insurance (now Global Atlantic), Philadelphia, PA
Technical Writing Intern June 1993-May 1995
As a technical writing intern during my undergraduate studies at Philadelphia University aided technical writers in the development of systems and policies & procedures manuals. Developed a handbook on the Family & Medical Leave Act (FMLA).
MS, Biomedical Writing, University of the Sciences in Philadelphia, degree received in May 2004
Immunology Graduate Program, University of Pennsylvania, attended 1995-1996, no degree
Included 2 semesters of PhD graduate coursework and laboratory research in 2 lab rotations.
Relevant Graduate Coursework: Pharmaceutical Marketing, Regulatory Affairs Med Devices & Biologics, FDA Law, Biomedical Publishing, Health Services Research Methods, Health Policy, Document Design & Testing, Writing for Continuing Medical Education, Biomed Adv. Grammar & Editing, Regulatory Writing, Bioethics, Biostatistics, Prof. Writing in Science, Immune Responses, Immune Mechanisms, Clinical Aspects of Cancer, Cancer Biology, Immunology I & II, Retrovirology.
BS, Biology, Jefferson (Philadelphia) University, degree received in May 1995 (GPA 3.784, Cum Laude)
Carnegie Mellon University, attended 1990-1992, no degree
Honors and Awards
· 1st Prize; Graduate Student Poster Award, 2001, Annual Meeting of the Drug Information Association (DIA)
· National Cancer Institute Fellowship, 1995-1996, University of Pennsylvania School of Medicine
· Semi-finalist; Elie Wiesel Prize in Ethics Essay Contest, 1995, Elie Wiesel Foundation for Humanity
· Dean's List, 1993-95, Philadelphia University
· Outstanding Senior Student in Science, 1995, Philadelphia University
· Student Government Awards for The TEXT, student newspaper, 93-94 & 94-95, Philadelphia University
· Harry Reimer Scholarship, 94-95, Philadelphia University
· Engineering Academic Merit Scholarship, 90-92, Carnegie Mellon University
· Bausch & Lomb Science Award, 90, Beaver Falls Senior High, Beaver Falls, PA
· Lions Club Academic Merit Award, 90, Beaver Falls Senior High
Organizations Memberships and Certifications
American Medical Writers Association, member
ISMPP, member and Certified Medical Publications Professional (CMPP) 2016-2021
Selected Publications and Presentations (Authored or Acknowledged)
Note: These are examples of my writing and publication planning experience. A portfolio of work can be provided on request.
· 2015-present, acknowledgments for medical writing of fosbretabulin abstracts/posters presented at NANETS, ICGS, ASCO-GI; samples available on request.
· Neurogenic Orthostatic Hypotension: Grand Rounds. Clin Auton Res. 2017;27(Suppl 1):1-43. (Acknowledged for all articles in the supplement)
· Bekaii-Saab T and El-Rayes BF. Identifying and Targeting Cancer Stem Cells in the Treatment of Gastric Cancer. Cancer. 2017. DOI:10.1002/cncr.30538 (Acknowledged)
· Gibbons CH, Schmidt P, Biaggioni I et al. The recommendations of a consensus panel for the screening, diagnosis, and treatment of neurogenic orthostatic hypotension and associated supine hypertension. J Neurol. 2017 Jan 3. doi: 10.1007/s00415-016-8375-x. (Acknowledged)
· In 2010-2011, acknowledgments for medical writing of crizotinib and sunitinib presentations/posters presented at ASCO, ASCO GI, ATS, ENETS, ESMO, and World Conference Lung Cancer; samples available on request.
· Bourcier ME and Vinik AI. Sunitinib for the treatment of metastatic carcinoid/paraganglioma, medullary thyroid cancer, and VIPoma. Pancreas. 2013;42(2):348-352. (Acknowledged)
· Kulke MH, Bendell J, Kvols L, Picus J, Pommier R and Yao J. Evolving diagnostic and treatment strategies for pancreatic neuroendocrine tumors. J Hematol Oncol. 2011 Jun 14;4(1):29. (Acknowledged)
· Shah J, Bladι J, Sonneveld P, Harousseau JL, Lantz K, Londhe A, Lowery C, Orlowski RZ. Rapid early monoclonal protein reduction after therapy with bortezomib or bortezomib and pegylated liposomal doxorubicin in relapsed/refractory myeloma is associated with a longer time to progression. Cancer. 2011 Feb 15.
· Bladι J, Sonneveld P, San Miguel JF, Sutherland HJ, Hajek R, Nagler A, Spencer A, Robak T, Lantz KC, Zhuang SH, Harousseau JL, Orlowski RZ; DOXIL-MMY-3001 Study Investigators. Efficacy and safety of pegylated liposomal Doxorubicin in combination with bortezomib for multiple myeloma: effects of adverse prognostic factors on outcome. Clin Lymphoma Myeloma Leuk. 2011 Feb 1;11(1):44-9.
· Patel M, G Thimons D, L Winston J, Langholff W, McGowan T. An open-label, randomized, multicenter, controlled study of epoetin alfa for the treatment of anemia of chronic kidney disease in the long-term care setting. J Am Med Dir Assoc. 2010 Nov 9. (Acknowledged)
· del Carmen M, Micha J, Small L, Street D, Lantz K, Londhe A, Lowery C. A single arm study of carboplatin and pegylated liposomal doxorubicin plus bevacizumab in subjects with platinum-sensitive recurrent ovarian, fallopian tube, and primary peritoneal cancers: an interim safety analysis. Poster presented at the Annual Meeting of the Society of Gynecologic Oncologists (SGO), March 2010, San Francisco, CA. Gynecol Oncol. 2010;116(3):abstract.
· Sparano J, Zhuang S, Londhe A, Lantz K, Lowery C. Relationship of anthracycline-free interval to outcomes in a phase 3 trial of pegylated liposomal doxorubicin plus docetaxel compared with docetaxel monotherapy in patients with advanced breast cancer treated with adjuvant anthracycline. Poster presented at the 32nd Annual San Antonio Breast Cancer Symposium, December 9 - 13, 2009.
· Bailey RA, McGowan T, Tang L, Lantz K, Wolfson M. Hemoglobin stability and excursions with extended dosing of epoetin alfa in patients with pre-dialysis chronic kidney disease. D&T: Dial Transplant. Oct 2009;38(10):407-411.
· Lipsky BA, Polis AB, Lantz KC, Norquist JM, Abramson MA. The value of a wound score for diabetic foot infections in predicting treatment outcome: a prospective analysis from the SIDESTEP trial. Wound Repair Regen. 2009 Sep-Oct;17(5):671-7.
· Wenning LA, Hanley WD, Brainard DM, et al. Effect of rifampin, a potent inducer of drug-metabolizing enzymes, on the pharmacokinetics of raltegravir. Antimicrob Agents Chemother. 2009 Jul;53(7):2852-6. Epub 2009 May 11. (Acknowledged)
· Shah J, Lantz K, Londhe, A, Lowery C, Orlowski RZ. Relationship of rapid M protein reduction to outcomes in a trial of pegylated liposomal doxorubicin + bortezomib versus bortezomib alone in previously treated multiple myeloma. Poster presented at American Society of Clinical Oncology; May 2009; Orlando, FL. J Clin Oncol. 2009;27:15s (suppl; abstract 8591).
· Shah J, Blade J, Sonneveld P, San Miguel J, Luo D, Lantz K, Lowery C, Harousseau J-L, Orlowski R. The effect of paraprotein heavy chain and free light chain types on the efficacy of pegylated liposomal doxorubicin + bortezomib versus bortezomib alone in patients with relapsed/refractory multiple myeloma. Blood (ASH Annual Meeting Abstracts). Nov 2008;112:5190.
· Shah J, Blade J, San Miguel J, Sonneveld P, Luo D, Lantz K, Lowery C, Harousseau J-L, Orlowski R. The effect of bone marrow involvement on the efficacy of pegylated liposomal doxorubicin + bortezomib vs. bortezomib alone in patients with relapsed/refractory multiple myeloma. Blood (ASH Annual Meeting Abstracts). Nov 2008;112:5192.
· Baquero F, Hsueh PR, Paterson DL, Rossi F, Bochicchio GV, Gallagher G, Lantz K, Villasenor JB, McCarroll K, Abramson MA, Chow JW. In Vitro Susceptibilities of Aerobic and Facultatively Anaerobic Gram-Negative Bacilli Isolated from Patients with Intra-Abdominal Infections Worldwide: 2005 Results from Study for Monitoring Antimicrobial Resistance Trends (SMART). Surg Infect (Larchmt). 2009 Apr;10(2):99-104.
· Brudi P, Massad R, Lantz K, Tershakovec AM. Patients attaining European Guidelines LDL-C goal (<2 mmol/L) in 3 studies evaluating switch to ezetimibe/simvastatin versus statin dose doubling. Poster presented at 77th Congress of the European Atherosclerosis Society; April 2008; Istanbul, Turkey. Available in Atherosclerosis. 2008;9(1):185-186.
· Baquero F, Rossi F, Hsueh P, Paterson D, Bochicchio G, Gallagher G, Lantz K, Baez-Villasenor J, Chow J. Antimicrobial susceptibility patterns of inducible Enterobacteriaceae isolated from intra-abdominal infections worldwide: results from SMART 2006. Poster presented at: 18th European Congress of Clinical Microbiology and Infectious Diseases (ECMID); April 2008; Barcelona, Spain.
· Lantz K, Tershakovec A, Brudi P, Polis A. Percent of patients attaining Joint British Societies' guidelines LDL-C levels <2 mmol/L in a 6-week study to evaluate ezetimibe/simvastatin vs. atorvastatin in patients with type 2 diabetes and hypercholesterolemia. J Clin Lipid. 2007;1(5):482. Poster presented at: 16th International Symposium on Drug Affecting Lipid Metabolism (DALM); Oct. 2007; New York, NY, USA. Located at: http://www.lorenzinifoundation.org/AbstractBookDALM2007.pdf
· Baquero F, Hsueh P, Paterson DL, Rossi F, Bochicchio GV, Gallagher G, Chow JW, Lantz K, Abramson MA. Worldwide antimicrobial susceptibility among E. coli isolated from intraabdominal infections (IAI): results from SMART 2006. Poster presented at: 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); Sep. 2007; Chicago, IL, USA.
· Rossi F, Hsueh P, Baquero F, Paterson DL, Bochicchio GV, Gallagher G, Chow JW, Lantz K, Abramson MA. Worldwide antimicrobial susceptibility among Klebsiella species isolated from intraabdominal infections (IAI): results from SMART 2006. Poster presented at: 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); Sep. 2007; Chicago, IL, USA.
· Lantz K. (contrib. ed.) Managed Care Best Practices in the Treatment and Management of Asthma. Supplement to Managed Care Magazine. 2005:14(8). (Contributing editor for 4 articles in the supplement.)
· Busch A. Leveraging the ion channel platform for lead generation in atrial fibrillation. Drug Discovery World. 2004;6(1):17-20. (Acknowledged)
· Lantz K. Do the data support preconceived notions about the effect of health insurance availability on healthcare utilization and perceived health status? Poster presented at: Annual Meeting of the Drug Information Association; June 2002; Chicago, IL, USA.
· Blackburn, GL. Dietary Patterns for Weight Management and Health. Obesity Research. 2001;9 (Suppl 4):217S-218S. (Acknowledged); Writing and editing all 22 articles in the supplement.
· Lantz K. A descriptive analysis of the readability of pharmaceutical company-sponsored diabetes education websites targeted to lay audiences.* Poster presented at: Annual Meeting of the Drug Information Association; July 2001; Denver, CO, USA. *First Prize, DIA Student Poster Award.
· Lantz K and Coble M. A systematic approach to Web-based product response letters. Poster presented at: Annual Meeting of the Drug Information Association; June 2000; San Diego, CA, USA.
· Lantz K. Applying criteria for authorship and acknowledgment to ghostwriters in scientific publications. Poster presented at: Annual Meeting of the Drug Information Association; June 1999; Baltimore, MD, USA.
· Coble M, Lantz K, and Albano M. Live versus online Internet continuing medical education activities: A retrospective evaluation and comparison. Poster presented at: Annual Meeting of the Drug Information Association; June 1999; Baltimore, MD, USA.
· Albano A, Coble M, Lantz K. Digital technologies used in writing and editing for scientific publications. Poster presented at: Annual Meeting of the Drug Information Association; June 1999; Baltimore, MD, USA.