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0-5 years of experience
Performed medical writing for multiple projects and provided input to project teams to support completion of accurate, quality regulatory documents
- Authored CSRs for drug and medical device clinical studies.
- Reviewed SAPs and TFLs.
- Oversaw timely internal and external reviews of draft and final documents
- Compiled and bookmarked CSRs for FDA submissions.
- Served as a project coordinator for a multicenter, Phase 3 study: identified qualified investigators; collected and reviewed regulatory documents, arranged investigator training sessions, tracked and reported start-up progress.
- Assisted in the planning of investigator meetings, prepared investigator meeting materials, and presented on regulatory requirements at meetings.
- Provided editorial review for business development documents.
0-5 years of experience
Extracted relevant data from the clinical protocol, statistical analysis plan (SAP), and CSR for inclusion in the NIH database - also referred to as www.clinicaltrials.gov, ENCePP, and EudraCT for the purposes of clinical trials registration and results disclosure
- Worked closely with the product team, across sites and countries, to ensure satisfaction and that corporate policy and NIH standards are exceeded, with regards to clinical trial transparency for all assigned products
- Prepared CSR study synopses in accordance with Merck Guidance Documents and the regulations of the German authorities
- Utilized knowledge of NIH regulations, applicable state and federal laws, and internal Merck policies
- Ensured assigned projects were delivered on time and under budget, through effective project management skills
- Preformed quality control assessments of all assigned deliverables for other medical writers
- Multifunctional role with teams spanning the globe
0-5 years of experience
Writes and coordinates preclinical and integrated clinical study reports; supports preparation of patent applications; prepares drafts of manuscripts and reviews articles for publication; and edits research grant proposals for extramural funding.
- Currently a peer-reviewer for Biologics: Targets & Therapy and Open Access Journal of Clinical Trials.
- Established collaboration with BioVentures Company that paved way to an application for a medical device patent with the US Patent & Trademark Office (Ucer and Mercado, 2012; Patent for an Automated Medication Dispenser).
- Published review articles and clinical practice guidelines on topics like stroke (Gabriel and Mercado, 2011; Abstract presented in the 3rd Annual International Epidemiology Congress), pulmonary tuberculosis (Gabriel and Mercado, 2011), and clinical trials (Gabriel and Mercado, 2011).
0-5 years of experience
Working as a freelance medical writer providing services to a network of biotech firms and pharmaceutical companies.
- Provided manuscript writing and editing services
- Synthesized, collected and edited clinical content for educational offerings
- Liaised with academics and KOLs to develop optimal publication strategy and carryout written deliverables
- Assisted in the development of selected medical education activities
0-5 years of experience
Biologist and Technical/Medical Writer and Editor for a large federal government academic research laboratory (National Cancer Institute, HIV and AIDS Malignancy Branch)
- Performed a variety of Molecular Biology, Biochemistry, Cell Biology and Immunology techniques and experiments for the advancement of cancer research.
- Designed, composed and implemented new protocols, procedures, manuals, user guides and training materials; adapted existing protocols, procedures, manuals, user guides and training materials to meet specific experimental goals, as well as ensured that they followed NIH Good Laboratory Practices guidelines and regulations.
- Assisted in the writing of papers published in scientific journals.
- Trained and supervised postdoctoral fellows, junior level lab personnel and students (high school through PhD/MD).
- Managed lab supplies and equipment, kept precise records of daily lab work, conducted computer-based data analysis and statistics.
0-5 years of experience
- Wrote and edited independent imaging review charters describing the diagnostic review of images, as determined by study protocol, published read criteria and FDA guidance
- Wrote and edited Clinical Study Reports and patient narratives
- Created training materials and image management guidelines for clinical sites
- Wrote new and revised existing SOPs and work instructions as well as Data Management Plans, Communication Plans and Project Management Plans
0-5 years of experience
Writer and editor of regulatory documents for ophthalmology products
- Worked primarily on therapy for posterior uveitis
- Wrote and edited protocols and CSRs for US, Japanese and European submissions
- Wrote and edited IBs, ISS/ISEs, 2.7.3 and 2.7.4 documents
- Reviewed and updated SOPs and internal writing style guides
- Wrote and edited patient narratives
6-10 years of experience
Regulatory writer for [company name], a consulting firm specializing in writing and editing for the pharmaceutical and biotechnology industries. Write and edit summaries of clinical pharmacology for Investigational New Drugs (INDs) and New Drug Applications (NDAs), clinical study reports and study protocols.
- Writing safety narratives, clinical study reports (CSR), involving assembly, quality control review on a weekly basis, and accuracy. Also, protocols in the areas of oncology, cardiovascular, women's health, and pharmacokinetics/pharmacodynamics.
- Effective communicator able to work with both management, clinical professionals and Contract Research Organizations (CROs) to provide clear, complete trial level agreements and contracts.
- Detecting and resolving quality issues on a weekly basis to ensure data/report milestone dates are met.
- Extensive Phase 1 clinical trail experience.
10+ years of experience
- Listed as as author or coauthor for a) recently published chapter on dog and cat anthelmintics in clinical pharmacology text, b) leukotriene inhibition review article published in refereed journal, and c) 6 articles published in veterinary trade magazines. Acknowledged for editing and writing assistance in a) update of 3 chapters in recently published dog and cat nutrition text and b) in over 10 clinical trial reports that were published in refereed journals.
- Was primary medical editor for Novartis' Publishing Endeavors and Pinnacle of Excellence Program in 2007 and 2008.
- Wrote and edited continuing education (CE) manuscripts. Served as the medical writer faculty member for Milestones in Oncology: Events that Changed the Course of Cancer Therapy and Implications for the Future, a 5-manuscript human CE booklet published in 2007 by The American School of Oncology. Acknowledged for writing and editing a veterinary technician CE manuscript on computed radiography.
0-5 years of experience
Wrote, edited, and published regulatory protocols, patient narratives investigational plans, and Clinical Study Reports in the clinical research areas of vision care, pharmaceutical, surgical, and refractive
- Edited medical abstracts and journal reviews for non-English authors
- Developed and updated templates and processes, reference guides, Field Observation Studies
- Served as Editor-in-Chief for a quarterly newsletter
- Developed Annual Reports, INDs, NDAs and CIBs
- Developed templates and style guides for the medical writing group
- Facilitated meetings related to a documentation review and approval of documents
- Applied ICH E3 standards for documentation development for FDA submission
- Received training on eCTD format submissions
0-5 years of experience
- Wrote, edited, and reviewed CSRs, IB, manuscript, section of cardiovascular NDA and Summary Basis of Approval (SBA).
- Reviewed clinical trial protocols, case report forms, and statistical analysis plans.
- Participated in project team meetings.
0-5 years of experience
- Prepared clinical documents such as clinical study reports, protocols, Investigator's Brochures, and FDA briefing documents
- Project managed the development of clinical trial and regulatory documents (including the review process and quality control steps, the delegation of appropriate tasks, and oversaw completion of tasks within established schedules and timelines)
- Collaborated with Regulatory on fulfilling FDA requirements for NDA submission of Trizytek; determined project milestones/deadlines and the resources needed to complete these projects
- Worked with biostatisticians and programmers to gather and analyze data for clinical study reports
- Researched scientific documents for source information and appraised and recommend references that supported report statements
- Created and maintained clinical document templates in accordance with approved company standards and ICH guidelines
- Participated in long-range planning for Medical Writing deliverables; developed and managed project plans, assessed resource needs
- Managed hiring process for Medical Writing, developed medical writing processes (SOPs and WPDs), trained and supervised hired writer
0-5 years of experience
- Serve as medical writer on clinical study teams for Phase 1 through Phase 4 projects in a variety of therapeutic areas. Planned and directed report-writing activities to ensure satisfactory completion of projects. Achieved project goals through ongoing collaboration with Sponsor representatives.
- Author full range of clinical regulatory documents including: protocols, protocol amendments, clinical study reports, investigator brochures, clinical development plans, submission briefing books, safety narratives, other study documents, IND/IDE submissions and annual reports, integrated summary reports, NDA & CTD submissions and annual reports, and other registration dossiers.
- Conduct QA review of regulatory submission documents
0-5 years of experience
Abstracts, posters, and manuscripts on clinical trials on vaccines (pneumococcal and meningococcal), postsurgical ileus, acid reflux, and other therapeutic areas
- Primary writer for manuscripts, posters and abstracts; main editorial support in author-drafted manuscripts
- Collaborated with in-house multimedia group for poster production
- Maintained productive relationships with internal and external authors in the planning, production, review, data quality review, and submission stages of publications
0-5 years of experience
Lead role in publication planning with the chief medical officer and key opinion leaders in the development of primary and secondary manuscripts
- Integral role in regulatory planning and submission of new drug application (NDA)
- Wrote manuscripts for journal publication
- Wrote abstracts and posters for conference submission
- Liaised between marketing, legal, and medical affairs departments
0-5 years of experience
Researched, conceived and planned SBIR grant proposal.
- Initiated dialogue with NIH and other funding organizations.
- Initiated a project to market biomarker that can predict anti-viral treatments response.
- Initiated consultation with Key Opinion Leaders to implement multicenter clinical trials.
- Established official collaboration with KOL.
0-5 years of experience
Write medical copy in a clear and easy to read format to encourage patient education
- Write collateral and educational materials to foster physician/patient interaction
- Write annotated guidelines for clients and sales rep training
- Annotate references for client submission using Adobe Acrobat
- Work with art directors and designers to recommend illustrations and format layout
- Edit medical copy before and during multiple stages of client approval (CRC)
- Review and rewrite medical copy submitted from external contract companies
0-5 years of experience
- Creates documents consistent with customers' internal guidelines as well as regulatory agencies
- Participates in project team meetings to provide input regarding deliverables, timelines and processes needed for the completion of medical documents
- Conducts comprehensive literature searches and performs critical analysis of clinical data
- Compiles, analyzes and summarizes data to be incorporated into medical documents
- Ensures that safety information, including adverse events, are reflected along with efficacy in medical documents
0-5 years of experience
Create basics for medical reports from research of clinical drug study protocols, statistical application plans, and charters.
- Create templates for standard reports including medical opinion letters, expert ECG reports, medical and statistical reports, report charters, and statistical analysis plans.
- Edit, proofread and finalize reports based on feedback from team subject matter experts.
- Maintain version control and archives of all reports.
0-5 years of experience
Write and edit Neuroscience health related articles for a variety of audiences, perform content and copy editing.
- Research and develop a variety of materials as background information to be used in preparing write-up preparation.
- Synthesize and translate complex scientific information into plain language.
- Develop documents and presentations for various research studies.
0-5 years of experience
- Write for medical journals and Denver hospital publications
- Carry publications through the entire production process: pitching story ideas, coordination of contributors, writing, editing and design, production management, and printer negotiations
- Edit copy for user-experience design
- Studied and practiced relevant publication-production software and new media
0-5 years of experience
- QC review of clinical documents: CSRs, Protocols, IBs, Amendments.
- Write Phase 1 Protocols, Amendments, Administrative letters, CSR shells.
- Creation of Department SOPs, Work Instructions and templates.
- Plan and prepare a variety of clinical documents (clinical study reports, investigator brochures, etc.) by organizing, analyzing, and interpreting scientific and statistical data.
- Prepare integrated summary documents for regulatory submissions.
- Participate in study teams, coordinate and conduct document-related meetings including the preparation of a pre-meeting agenda and post-meeting minutes.
- Review protocols, clinical data reports, and case report forms as required.
0-5 years of experience
- Wrote study protocols, abstracts, manuscripts, posters, medical education material, investigator brochures, clinical study final reports, data summaries
- US and international regulatory submissions (INDs, NDAs, IMPDs, amendments, supplements)
- Project management skills
- Ability to interpret and present data accurately and concisely
- Editing/rewriting skills
- Knowledge of therapeutic areas and regulatory guidelines
- Insure documents are of high quality in terms of scientific content, organization, accuracy, format, clarity, and consistency
- Scientific information retrieval
