Medical Writer Resume Template
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IndustryCarrer Level Professional
Written by Dua Khan
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Carrer Level Professional
Written by Dua Khan
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Principal Medical Writer Resume Example
ELENA R. VON MEYER, PhD
Leuven, Belgium| +32 491 28 55 94| [email protected]
Principal Medical Writer | Project Management | Research | Regulatory Compliance
CAREER SYNOPSIS
Accomplished and driven medical writer with a proven track record in producing high-impact, scientifically rigorous content across a diverse range of therapeutic areas. Aspiring leader, with a comprehensive background in crafting compelling publications, slide decks, and educational materials. Adept at collaborating with Key Opinion Leaders (KOLs) to author CME content while maintaining strict adherence to guidelines. Committed to employing scientific acumen, and writing prowess to drive innovative medical communication strategies.
AREAS OF EXPERTISE
Therapeutic Areas: Neurology/Psychiatry | Cardiology/Hematology | Oncology | Immunology | Hepatitis | Rare Disease | Women’s Health | RNA Therapies
Writing Experience: IBs | CSRs | Patient Narratives | Protocols | Module 2.7.3 | Briefing books | Standard Response Letters | Abstracts, Posters, Slide Decks | Publications | KOL Engagements | Symposia & Advisory Boards | KOL & Patient Videos | MSL/Sales Education | Website and Interactive Web Content
Software: eCTD | Veeva Vault | MS Office (Word, Excel, and Project) | Reference Manager | EndNote PubMed | Clinicaltrials.gov | Document Management Systems (Zinc, Veeva Vault, SharePoint, DataVision) | Adobe Suite (Illustrator, InDesign, Photoshop) | HTML | CSS | JAVA
PROFESSIONAL EXPERIENCE & IMPACT
CertMedica (Global Regulatory Writing Unit) | Amsterdam, Netherlands| Senior Regulatory Writer, Client Lead, Process Driver | May 2018 – Present
- Selected as the Co-chair of the DIA-MASC Program (Drug Information Association- Medical and Scientific Communications) in 2023
- Embedded Process Driver for a Leading Pharmaceutical Company:
- Spearhead writing, approval, and publication process of investigator brochures and regulatory documents (protocols, briefing documents).
- Mentor newer writers, managed workflow of internal scientist functional writers, and report to client medical writing leads.
- Utilize Veeva Vault and SharePoint for electronic document management.
- Manage timeline and communication with international teams in Japan and the UK.
- Lead Writer for Various Submissions:
- Produce Clinical Study Reports (CSRs), Investigator Brochures (IBs), protocols, and submission modules (2.7.3) for NDA and BLA submissions.
- Demonstrate expertise in rare diseases, oncology, neurodegenerative diseases, and migraine therapeutic areas.
- Serve as Subject Matter Expert (SME) for hATTR and RNA therapy.
- Collaborate closely with Business Development, Quality Control/Quality Assurance, and Publishing teams; lead and mentor writers and editors, overseeing contractors as required.
- Oversee writer training, engage with clients, and maintain project management standards.
International University of Health Sciences (Remote) | Adjunct Professor | January 2013 – January 2019
- Designed and delivered engaging course content, fostering student understanding and participation.
- Facilitated classroom discussions and debates that encouraged critical thinking and collaborative problem-solving skills.
Freelance Medical Communications Consultant (Europe/US) | Medical Director | May 2013 – May 2018
- Created engaging slide decks, publications, and abstracts for multiple medical education companies.
- Developed and conducted comprehensive sales and Medical Science Liaison (MSL) training programs.
- Specialized in medical content related to oncology, hematology, cardiology, ulcerative colitis, and multiple sclerosis.
THOS Medical Communications | Brussels, Belgium | Senior Medical Director | February 2013 – November 2013
- Managed speaker’s bureau operations, including conducting impactful webinar speaker training, reviewing presentation slides, and maintaining open communication with speakers.
- Initiated and executed a dynamic “roadshow” for PNET (Primitive Neuroectodermal Tumor) across prominent medical centers.
- Partnered with the medical affairs team to strategize and implement pre-launch activities, such as developing compelling Health Economics and Outcomes Research (HEOR) decks, coordinating publication plans, crafting manuscripts, abstracts, slide decks, and posters, and orchestrating advisory board meetings.
- Specialized in diverse therapeutic areas including oncology, schizophrenia, multiple sclerosis, Alzheimer’s, and Fragile X.
- Led and mentored a team of junior writers, ensuring their work aligned with quality standards through thorough oversight and editing.
ArtScience Health Communications | Ghent, Belgium | Associate Director of Scientific Services | 2010 – 2013
- Spearheaded diverse multimedia projects, including the creation of sales training materials, HEOR value proposition training for global operating firms, and educational websites tailored for newly diagnosed patients.
- Collaborated with webmasters to successfully develop a comprehensive 12-part interactive online learning program, catering to parents of recently diagnosed boys with hemophilia.
- Orchestrated two extensive online clinical trial recruitment initiatives, encompassing vaccine and epilepsy studies, which featured user-friendly patient and healthcare professional (HCP) web portals.
- Crafted engaging and informative materials for diabetes education and the Nascobal B12 sales training manual, catering to audiences with eating disorders, gastric bypass, Crohn’s, GI surgery, and the elderly.
- Produced an award-winning caregiver booklet addressing schizophrenia and hepatitis C, showcasing dedication to impactful patient resources.
- Developed internal slide decks tackling biologics and hematologic tumors, contributing to internal knowledge sharing.
- Created compelling animations and radio scripts to enhance project engagement and communication.
Global MedComm Group | Brussels, Belgium | Adjunct Professor | August 2008 – June 2009
- Designed comprehensive lesson plans that catered to various learning styles, ensuring effective comprehension and retention of course material.
- Employed innovative teaching methods, incorporating multimedia tools and real-world examples to enhance students’ practical understanding of complex concepts.
Global MedComm Group | Brussels, Belgium | Senior Medical Director | 2007 – 2008
- Directed a cross-functional team composed of project managers, account directors, and medical writers to deliver exemplary client account services.
- Orchestrated comprehensive gap analyses and strategic publication plans, facilitating international symposia and collaborating with global Key Opinion Leaders (KOLs).
- Oversaw the meticulous collection, formatting, and editing of presentation slides and enduring materials, including journal supplements.
- Conducted on-site rehearsals and training sessions, effectively refining speaker performance and content delivery.
- Coordinated logistical aspects including organizing dinners, accommodations, and travel arrangements for esteemed speakers.
- Specialized in the domain of women’s reproductive health products and urinary incontinence.
- Utilized PubStrat software to streamline and optimize various processes.
Independent Medical Communications Consultant | Remote | Medical Director | October 2005 – December 2007
- Delivered impactful contract work for numerous medical education companies; produced persuasive slide decks and publications.
- Applied specialized expertise to create tailored sales training for diverse products including hemophilia, infant formula, schizophrenia, cardiology, and neurology.
Continuum Medical Education (CME) Alliance | Hybrid Remote–EU Based | Medical Director | October 2005 – October 2006
- Created scientifically rigorous needs assessments for grants, and developed compelling scripts for audio and TV platforms.
- Edited and reviewed online web-based materials, newsletters, and slide decks.
- Cultivated strong relationships with Key Opinion Leaders (KOLs), collaborating closely to author CME content and adhering to established guidelines.
- Orchestrated multiple concurrent and ongoing large-scale strategic CME satellite symposia.
- Consulted with KOLs to meticulously gather, format, and refine presentation slides, elevating the quality and impact of symposia content.
- Demonstrated specialized proficiency in therapeutic areas such as schizophrenia, insomnia, and neurology.
ADDITIONAL EXPERIENCE
MedCom Global (EU Division)| Senior Medical Director
County College of Morris | Randolph, NJ | Adjunct Professor
Life Sciences Department, Community College Consortium | Senior Medical Writer
EDUCATION AND PROFESSIONAL DEVELOPMENT
M.S./Ph.D., Microbiology and Molecular Genetics | University of Utrecht / Radboud University (Joint Program)
B.A., Biology | University of Antwerp
Online MOOC, Java for Android Studio/Mobile App Development | Vanderbilt University
Web Design Course in Dreamweaver/CSS | DeVry
Web Design, including HTML and JavaScript | Middlesex County Community College
Certified Medical Publication Professional (CMPP) | International Society for Medical Publication Professionals (ISMPP) | 2012 – 2023
PUBLICATIONS AND PRESENTATIONS
- Drug Information Association (DIA) Medical Affairs and Scientific Communications Annual Meeting. April 17-19, 2023. “Innovative technology for Medical Writers.” Session Chair
- Drug Information Association (DIA) Medical Affairs and Scientific Communications Annual Meeting. March 21-23, 2022. “Recruiting and Retaining Medical Writers.” Session Chair.
- Drug Information Association (DIA) Medical Affairs and Scientific Communications Annual Meeting. March 22-24, 2021. “Applying learnings from rare disease to support diversity in clinical trials.” Session Chair.
- “Guiding journal targeting: shooting for the moon may leave you lost in space.’ Presenter
- Cleverley D. How to talk to about pain so your doctor will listen. US Pain Foundation. Jan 8th, 2020.
- Cleverley D. Can a web-based tool to facilitate communication between patient and healthcare providers improve patient-reported outcomes? Value Health 2015;18(11): A111.
- Cleverley D, Hilton D. Patient education: the sunny side of the street. MedAd News. May, 2011.
- Cleverley DZ, Lenard J. The transmembrane domain in viral fusion: essential role for a conserved glycine residue in vesicular stomatitis virus G protein. Proc Natl Acad Sci USA. 1998;95(7):3425-30.
- Cleverley DZ, Geller HM, Lenard J. Characterization of cholesterol-free insect cells infectible by baculoviruses: effects of cholesterol on VSV fusion and infectivity and on cytotoxicity induced by influenza M2 protein. Exp Cell Res. 1997;233(2):288-96.
- Gao Y, Greenfield NJ, Cleverley DZ, Lenard J. The transcriptional form of the phosphoprotein of vesicular stomatitis virus is a trimer: structure and stability. Biochem 1996;35(46):14569-73.
Related Medical Writer Resume Template
Resume Guide for PhD-Level Medical Writers and Regulatory Experts
For a seasoned medical writer with advanced degrees, extensive regulatory experience, and a proven record of impactful medical communications like Elena R. Von Meyer, your resume must clearly showcase your scientific rigor, regulatory expertise, writing excellence, and leadership in medical education. Below is a step-by-step guide to creating a distinctive resume tailored specifically to professionals with similar expertise, written by a team of professional resume writers from our medical resume writing service online.
Step 1: Professional Summary – Emphasizing Scientific Depth and Strategic Impact
Your summary should reflect your high-level scientific credibility, extensive regulatory and medical communications experience, leadership abilities, and success in producing scientifically accurate, engaging content.
Custom Example:
“Accomplished PhD-level medical writer and regulatory expert with extensive experience authoring high-impact, scientifically rigorous regulatory documents, educational content, and publications across diverse therapeutic areas including oncology, neurology, rare diseases, and RNA therapies. Demonstrates strong leadership in project management, strategic KOL collaborations, and training medical writing teams. Adept at navigating regulatory environments (FDA, EMA), enhancing scientific credibility, and driving impactful medical education strategies.”
Quick Tips:
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- Highlight scientific and regulatory expertise clearly.
- Include specific therapeutic areas and types of deliverables you’ve authored.
Step 2: Areas of Expertise – Aligning Medical Writing Skills with Industry Demand
Highlight core competencies that clearly demonstrate your value in medical communications, regulatory writing, publication planning, and medical education.
Tailored Skill Set Example:
Scientific & Regulatory Writing:
- Clinical Study Reports (CSRs), Investigator Brochures (IBs), Protocols, Module 2.7.3
- FDA and EMA Submission Documents
- Standard Response Letters & Patient Narratives
Therapeutic Expertise:
- Neurology/Psychiatry, Oncology, Immunology, Rare Diseases, RNA Therapies
Medical Communications & Education:
- Slide Decks, Abstracts, Posters, CME content
- KOL Engagement & Advisory Boards
- MSL/Sales Training Programs
Technology & Tools:
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- Veeva Vault, eCTD submissions, PubMed, EndNote
- DataVision, Adobe Creative Suite (Illustrator, InDesign), HTML, CSS, Java
Quick Tips:
- Categorize your skills clearly to highlight your versatility.
- Include specific therapeutic areas and document types you’ve mastered.
Step 3: Professional Experience – Highlighting Regulatory Excellence and Scientific Impact
Translate your experience into concise, compelling achievements that resonate with hiring managers, emphasizing regulatory expertise, strategic writing impact, and leadership.
Example Inspired by Elena’s Role:
Senior Regulatory Writer & Client Lead
CertMedica (Global Regulatory Writing Unit), Amsterdam, Netherlands | 2018 – Present
- Led development of regulatory submission documents including Clinical Study Reports, Investigator Brochures, Briefing Books, and Module 2.7.3 summaries, securing timely and compliant regulatory submissions to FDA and EMA.
- Directed international medical writing teams across EU, US, Japan, and UK; streamlined processes, improving submission timelines by 20%.
- Selected as Co-chair for DIA-MASC Program (Drug Information Association) 2023, representing industry leadership in medical communications.
- Served as SME for hATTR amyloidosis and RNA therapies, strengthening scientific rigor across regulatory submissions and client communications.
Quick Tips:
- Focus on achievements that showcase regulatory compliance and scientific accuracy.
- Highlight leadership roles, mentorship, and international collaborations.
Step 4: Highlighting Medical Education, KOL Collaborations, and Strategic Communications
Clearly highlight your ability to create educational materials, engage with KOLs, and drive impactful scientific communication strategies.
Example:
Medical Director & Senior Medical Writer
THOS Medical Communications, Brussels, Belgium | 2013
- Managed high-level KOL advisory boards and educational symposia; executed a successful “roadshow” program on Primitive Neuroectodermal Tumors (PNET).
- Authored influential CME content and HEOR decks across oncology, neurology, and rare diseases; significantly enhancing physician education and patient outcomes.
- Trained speakers through tailored webinars and content reviews, elevating overall program quality and scientific credibility.
Quick Tips:
- Emphasize leadership in medical education initiatives.
- Highlight collaboration with influential KOLs to enhance scientific credibility.
Step 5: Academic Teaching Experience – Demonstrating Thought Leadership
Showcase your academic roles to underline your ability to educate, mentor, and convey complex scientific concepts effectively.
Example Inspired by Elena’s Teaching Roles:
Adjunct Professor
International University of Health Sciences (Remote) | 2013–2019
- Designed and delivered engaging course content, incorporating evidence-based methodologies and interactive discussions to promote deep understanding of medical sciences.
- Fostered critical thinking and scientific inquiry among graduate students, consistently earning outstanding student evaluations.
Quick Tips:
- Highlight the impact and scope of your academic contributions clearly.
- Include evidence of teaching effectiveness (student evaluations, course innovations).
Step 6: Publications, Presentations, and Industry Engagement
Clearly display your industry involvement, speaking engagements, and publications to validate your professional credibility.
Example Based on Elena’s Profile:
- Session Chair: DIA Medical Affairs & Scientific Communications Annual Meetings (2021-2023), leading discussions on innovative technologies and strategic recruitment for medical writers.
- Publication Highlights:
- “Can a web-based tool to facilitate communication between patients and healthcare providers improve outcomes?” Value Health, 2015
- “Guiding journal targeting: Shooting for the moon may leave you lost in space,” Medical Writing Conference Presentation, 2021
Quick Tips:
- Showcase your industry thought leadership prominently.
- Include examples that highlight your expertise in medical communications.
Step 7: Education & Professional Development – Establishing Scientific Credibility
Highlight advanced education clearly, including specialized certifications relevant to medical and regulatory writing.
Example:
- Ph.D., Microbiology & Molecular Genetics, University of Utrecht / Radboud University, Netherlands
- Certified Medical Publication Professional (CMPP), ISMPP, 2012–2023
Quick Tips:
- Include relevant certifications and advanced degrees clearly.
- Highlight continuous professional development.
Final Thoughts and Key Takeaways
When crafting a resume for PhD-level medical writing and regulatory roles, remember to:
- Emphasize your advanced scientific education and regulatory expertise.
- Clearly highlight your medical communication skills, KOL engagement, and CME experience.
- Provide clear, measurable impacts of your work (e.g., improved processes, successful regulatory submissions, influential educational programs).
This approach from certified online resume writers positions you as a uniquely qualified medical writing professional, fully equipped to deliver impactful scientific communications and regulatory leadership in a complex global healthcare environment.