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Click here or scroll down to respond to this candidateCandidate's Name , MSc.Address: Street Address Email: EMAIL AVAILABLEClinical Research ProfessionalVISION STRATEGY PLANNING IMPLEMENTATION LEADERSHIPSeasoned Medical Writer with extensive experience in drafting and revising clinical development documents including Clinical Study Reports (Phases 1-4), Clinical Protocols, DSURs, Investigator Brochures, INDs, IMPDs, NDAs, BLAs, and Patient Narratives. Proficient in adhering to ICH/GCP guidelines and client SOPs. Expertise across a wide range of therapeutic areas.THERAPEUTIC AREASOncologyPain ManagementMedical DevicesInfectious DiseasesHematologyOpioid DependencyRare DiseasesOphthalmologyDiabetesUpper GICNSBiological ThreatsVaccinesAutoimmuneSKILLSSuperior written English; capable of accurate data interpretation and clear expression of findings.Knowledge of FDA/EU/Canadian clinical trials, registrations, and regulations.Excellent project/time management, organizational skills, and the ability to work independently.Flexibility in meeting challenging deadlines and changing requirements.Effective communication with professionals from various backgrounds.Attention to detail: style, consistency, grammar, syntax, and scientific accuracy.Strong interpersonal skills and confidence in client/author management.PROFESSIONAL EXPERIENCEFreelance Medical Writer Remote 02/2023 CurrentFreelanceProvided medical writing, editing, and proofreading services for Agenus Biotechnology, Keros Therapeutics, and Austin Bio Consulting.Specialized in clinical documents including CSRs, IBs, DSURs, Protocols, Briefing Books, and ICFs.Forma Therapeutics Watertown, MA 04/2022 10/2022Director of Medical Writing Acquired by Novo NordiskWorked independently using knowledge and experience to prepare, edit and finalize protocols, investigator brochures, synopses, regulatory documents, and other related clinical documentsParticipated in scientific communication planning, including the development of strategic medical communication plansPartnered with the study biostatistician to engage early with the study/ program team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documentsApplied technical, line, and business knowledge to plan and coordinate all aspects of timelines for the medical writing deliverables across one or more programs to align with company goals and enable the function to meet its goals.Worked closely with program and study teams to reach a consensus on clear timelines for deliverablesAlerted project, line, and senior management as appropriate of possible timeline delays and propose and implement mitigation strategies as appropriateWorked closely and independently with the study teams to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.Facilitated alignment of messaging across programs to reflect program strategy and goalsScheduled and conducted document-related meetings including the preparation of the pre-meeting agenda, key data points for discussion, meeting facilitation, and post-meeting minutesDeveloped and leveraged constructive relationships with the cross-functional project team and workgroup members to support effective team interactions and delivery of team goals.Collaborated with clinicians, clinical scientists, biostatisticians, and pharmacokinetics to interpret study results and ensured study results and statistical interpretations were accurately and clearly reflected in relevant documents.Led and managed the document preparation team through the review process ensuring conflicting and/or ambiguous comments were clarified and appropriately addressed; facilitated and resolve complex discussions to gain agreement.Supervised the work of other internal/external medical writers and overseen contract medical writers to effectively meet company goalsEnsured that appropriate documented quality control (QC) checks were performed on medical writing deliverables, respond to findings, and recommend and implement quality process improvementsBuilt expert knowledge of changes in regulatory guidelines and application of these and provided expertise on these as it relates to the preparation and submission of documents to regulatory authoritiesReviewed work completed by other colleagues to ensure compliance with guidelines and standards.CymaBay Therapeutics, Inc. Newark, CA 03/2021 03/2022Director of Medical Writing COVID Lay OffConducted background research on indications and studies to establish references and scientific base for documents in developmentDeveloped internal style guides to ensure consistency across documentsAssisted in the preparation and review of key study regulatory briefing documents and other regulatory submissions, and annual reportsSupported writing efforts on Companys first NDA, and new INDs/CTAsAdministered study registration accounts (e.g., www.clinicaltrials.gov)Collaborated on development of clinical study documents (e.g., Investigator Brochure, protocols, and clinical study reports), in accordance with applicable regulationsLiaised with CRO medical writer delegates for clinical documents (e.g., clinical study reports and protocols)Participated in/led comment resolution meetings, as applicablePerformed a quality control (QC) check of a contracted written documentsParticipated in the preparation of possible abstracts and/or journal submissionsParticipated in teams meeting as applicableCorrelated with epidemiologists, statisticians, and clinical scientist professionals for on-going and established studies or other projects where extensive methodological or SME interpretation is requiredCompleted other responsibilities as assigned and agreed uponPrincipia Biopharma South San Francisco, CA 08/2020 12/2020Director of Medical Writing Acquisition by SanofiProvided leadership, planning and project management to ensure the completion of key documents (e.g., Investigator's Brochures, DSURs, clinical protocols, clinical study reports (CSRs), and clinical summary documents (such as integrated summaries of efficacy and safety), using data provided and in a format compliant with the governing regulatory agency.Used scientific expertise to write, review, and edit reports such as the clinical protocol, investigator brochure, clinical study report, informed consent, risk/benefit analysis and integrated summary and annual reports.Ensured key messages were clear and consistent across and within documents and contributes strategically and scientifically at the program level.Managed external (4) and internal (2) medical writing resources and needs.Collaborated effectively with cross-functional personnel, managing writing projects to ensure that background materials were provided, timelines were communicated, questions were addressed, comments adjudicated, and the documents were completed on time with high-quality.Worked closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.Partnered with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents.Collaborated with clinicians, clinical scientists, biostatisticians, and clinical pharmacologists to interpret study results and ensure study results and statistical interpretations were accurately and clearly reflected in relevant documents.Provided editorial support and review for other medical communication documents such as abstracts, journals, and presentations for scientific meetings.Ensured a consistent style of document presentation to maintain quality and ease of review and led the development of style standards and guidelines for preparation of clinical documents submitted to regulatory agencies.Led document reviews and comment resolution meetings with cross-functional teams.Self-directed and collaborated while building strong working relationships across multiple departments to finalize documents, including in high-pressure situations.Demonstrated in-depth knowledge of clinical regulatory documentation requirements (familiar with GCP, CTD, FDA, and ICH requirements).Demonstrated ability to successfully manage multiple projects from conception to completion, working collaboratively in a team environment.Demonstrated experience in the preparation of protocols, study reports, investigator brochures, safety updates, and Regulatory documents, including IND and NDA submissions.Demonstrated ability to communicate and write clearly, concisely, and effectively with an aptitude for compilation, analysis, and presentation of data.Effectively communicated the medical writing activities, plans, scope(s) of work and ways of working across the organization.Demonstrated strong organizational, verbal communication, and computer skills.Knowledge of eCTD publishing requirements.Emergent BioSolutions Gaithersburg, MD 02/2019 08/2020Manager Medical Writing Lay OffProvided leadership within the Medical Writing function for Emergent BioSolutions Clinical Development & Operations; 2 internal writers and 1 contractor.Ensured the medical writing function was professionally managed and represented both within and external to the company, provided support and expertise to members of the clinical team.An agent for change for professional and team development.Provided and overseen medical writing aspects of several outsourced clinical research programs securing quality and best value always.Ensured critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) compliant presentation.Executed all comments meetings and drove all timelines for all medical writing projects.Managed review and approval process of clinical submissions documents, which included authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner.Provided process, content, and submission/document planning expertise. Advised team on resource utilization, efficiencies, timelines, and interdependencies.Overseen preparation of clinical submission documents for a program; review and provided feedback on clinical submission documents to maintain consistent content, messaging, and style.System administrator for clinicaltrials.gov; set up accounts, posted and approved study results.Reviewed protocols, statistical analysis plans, and tables figures and listings.Ensured adherence to established regulatory, company SOPs and House Style, general quality and ICH/GCP guidelines.Wrote, reviewed, and updated company SOPs and related templates (e.g., CSR, protocol, briefing books, narratives, IB).Prepared and represented Medical Writing for internal (QA) and external audits (MHRA, FDA)Participated in and/or led the development of processes and tools related to authoring and reviewing of clinical documents. Continually shared best practices to create higher quality documents more efficiently for the delivery of critical milestones.Summarized clinical trial data and analyzed and interpreted clinical data, discussing results with internal teams and KOLs.Liaised with vendors/external contractors as assigned. Ensured timelines and quality of product when the writing of a document was outsourced.Prepared study data summaries and other documentation for public disclosure in accordance with data transparency guidance and regulations.Mentored, coached, and/or otherwise assisted in the training and development of other Medical Writers.Protagonist Therapeutics Newark, CA 03/2018 02/2019Sr. Medical Writer ResignedDeveloped and maintained medical writing processes, standards, and tools (e.g., SOPs, work instructions, templates, style guide, etc.).Set up all logistics and background information to run the newly created medical writing department.System administrator for Documentum, PleaseReview, and the Starting Point templates.Worked effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents.Formed the medical writing group and logistics (e.g., SOPs, templates, document reviewing systems).Was responsible for ensuring that assigned documents underwent a QC check before approval, and that documents were routed correctly during review and approval cycles.Managed timelines and communicated with team members to maintain awareness of expectations, critical milestones, and deliverables.Wrote, edited, or collaborated on the development of high-quality clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books).Ensured clinical documents and adhered to Protagonist standards and regulatory guidelines.Coordinated and managed contract medical writers as needed.Had working knowledge of PubMed and other medical/scientific resources.Communicated project status to internal/external stakeholders through various formal and informal mechanisms.Amicus Therapeutics Cranbury, NJ 07/2017 03/2018Medical Writer Contract EndedPrepared clinical study protocols, clinical study reports, briefing books or other regulatory documents supporting ongoing clinical development programs, while maintaining version control of the Regulatory documents.Developed of the documents supportive appendices (or sections of these) by the incorporation of text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner consistent with the target audience and regulatory requirements.Consolidated and evaluated teammates review comments to determine needed revisions.Reviewed statistical analysis plans and accompanying table and listing shells for the evaluation and presentation of clinical trial data.Quality-checked documents for agreement between in-text information and the source data, and for internal consistency.Created lexicons for both Fabry and Pompe diseases.Editorial reviewed documents for grammar, punctuation, and submission-compliant formatting.Provided overall medical writing support for ongoing Fabry and Pompe programs.Utilized instructions, templates, and pre-established guidelines (e.g., Standard Operating Procedures).Worked independently and efficiently with cross functional team members.Screened and interviewed contract medical writers to join the medical writing team.Managed QC processes for the NDA and JNDA in conjunction with CRO.Sanofi Cambridge, MA 08/2016 07/2017Sr. Medical Writer Contract EndedCreated, without supervision, any type of clinical regulatory document for oncology studies (e.g., protocol, CSR, CIB, briefing books, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and presented clinical data objectively in a clear, concise format, while maintaining version control.Demonstrated leadership preparing multiple key summary submission documents (i.e., Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) for the CTD.Worked independently and cross functionally to prepare clinical regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines.Ensured a consistent style of presentation of clinical document to maintain quality and ease of review and adhered to company standards.Maintained positive relationships with KPLs.Contributed to Clinical Cluster, Project Team, and Submission Task Force meetings and to cross-functional working groups as needed to facilitate efficient development and submission of products.Created PowerPoints and presented slide deck at annual medical writing conferences.Mentored junior medical writers and provided leadership in completion of large writing projects to foster team development.Indivior Inc. Richmond, VA 02/2015 08/2016Sr. Medical Writer Lay OffProvided clinical medical writing services that included writing and editing of clinical/regulatory/ medical documents including study protocols, clinical study reports, informed consents, briefing books, investigator brochures, annual safety reports, and scientific manuscripts.Wrote and/or coordinated with internal and external interacting resources the clinical and related sections of INDs, NDAs, CTAs, and similar documents.Resolved conflicting comments among reviewers and with multidisciplinary team members as appropriate.Discussed with the relevant stakeholders the objectives, timelines, and documents to be generated; coordinated contributions from other individuals and groups.Coordinated QA review of documents and maintenance of audit trails/version control.Performed literature searches as necessary to obtain requisite information.Attended study kick-off meetings and facilitated comments resolution meetings.Served as primary contact between Indivior and the vendors.Managed the activities of medical writing vendors (i.e., individual consultant medical writers and/or CRO medical writers).Valesta Clinical Research Richmond, VA 05/2014 07/2014Medical Writer Contract EndedServed as the primary medical writing representative on assigned product teams and closely collaborated with personnel from clinical, regulatory, and scientific departments.Managed the writing, editing, and reviewing of diverse regulatory & clinical documents including clinical study reports (CSRs), study protocols, investigator brochures, briefing books, informed consent forms, clinical data summaries, other medical/regulatory documents and maintained version control.Took ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.Acquired familiarity with and worked in accordance with Federal Regulations, Good Clinical Practices and ICH guidelines and Standard Operating Procedures.Research Pharmaceutical Services Jacksonville, FL 04/2012 12/2014Sr. Medical Writer Acquisition by PRADrove all aspects of the document preparation process; received and reviewed primary statistical output, drafted, and distributed completed documents for review, and compiled comments and edits as necessary for Vistakons ophthalmological (contact lenses) division for Phase I-IV (MDR) studies.Prepared and overseen (6 Medical Writers based out of India) the preparation of clinical regulatory submission documents and manuscripts.Ensured adherence to department guidelines, templates, SOPs, and regulatory guidelines for all Medical Writing documents provided for their therapeutic area.Ensured all documents met global compliance with regulations (FDA, EU, & Canada), and that key team messages were clearly represented.Reviewed study concepts and edited protocols for consistency, progression, structure, grammar, and maintained version control.Evaluated, interpreted, and incorporated statistical analysis plans into clinical study reports.Constantly (re)prioritized work to manage projects often requiring multitasking skills.Maintained time and event schedules in relation to protocol review and development.Achieved project objectives while operating within challenging timelines in a fast-paced environment.Worked with medical writing management for strategic planning, production & review of assigned summary documents.Gathered, organized, and compiled information on new products or processes for various technical professionals.Created Ecollabora, a template documentation system based on ICH guidelines to ensure proper format in all documentation.WorldWide Clinical Trials Austin, TX 07/2011 - 04/2012Medical Writer Contract EndedLed the production of high-quality documents in compliance with ICH requirements and WCT SOPs; ensured consistency across documents, improved overall document quality, and maintained version control.Assisted with the preparation of study feasibility questionnaires and related reports under the purview of Medical & Scientific Affairs.Acquired working knowledge of clinical study designs, common analysis methods, descriptive and common inferential statistics, and data presentation practices.Cross functionally consulted SMEs and KPIs for study related guidance.Participated in team meetings and group discussions while working in a fast-paced environment.Maintained knowledge of data management processes, including EDC processes, documents, and data flow in clinical trials.Performed QC and accuracy reviews and applied companys editorial style.Performed interpreted data of statistical analysis.Advised and mentored colleagues and clients on medical writing-related issues and procedures.US Oncology The Woodlands, TX 05/2010 - 07/2011Regulatory Medical Writer Acquisition by McKessonPrepared study-specific informed consents from an IRB-approved template; delivered protocols, amendments, CSRs and ICFs for drug and MDR studies.Created and edited protocols and ICH/Summary reports.Worked cross functionally and led comments resolution meetings.Wrote protocol and SOP manual writing.Managed completion and submissions of all documents and maintained version control.Participated in both group and moderately complex companywide process improvement and development initiatives.Performed QC and medical editing reviews on regulatory documents.Managed regulatory authority applications and approvals regarding the research/marketing of new/existing drugs.Set-up and monitored systems used by clinical research assistants to ship CT materials to investigators and maintained procedures to account for and verify the expiration of CT materials.Maintained positive relationships with KOLs and external clients.Christus St. John Hospital Nassau Bay, TX 05/2007 - 05/2010PATIENT ACCESS MANAGERSupervised and managed the patient access team, including registration clerks, admission coordinators, financial counselors, and other related staff.Overseen scheduling, staffing, training, and performance evaluations to ensure optimal department functionality.Developed and implemented departmental policies and procedures to enhance efficiency and accuracy in patient access services.Ensured compliance with all relevant healthcare regulations, including HIPAA, EMTALA, and JCAHO standards.Monitored and audit patient access processes to ensure accuracy, completeness, and adherence to policies.Developed and implement quality assurance programs to continually improve department performance and patient access metrics.Christus St. John Hospital Nassau Bay, TX 02/2005 - 05/2007Central Supply/Sterile ProcessingDecontaminated, cleaned, packaged, and sterilized medical instruments and equipment using autoclaves, sterilizers, washers, and other related equipment.Ensured all instruments and equipment were properly disinfected and free of contaminants.Monitored and maintained inventory levels of sterile supplies, medical instruments, and equipment.Ordered and restocked supplies as needed, ensuring no shortages occurred.Conducted regular inventory checks and managed stock rotation to avoid expired items.St. Joseph Hospital Houston, TX 01/2007 - 05/2008PATIENT ACCESS REGISTRAR (PRN)Verified patient insurance coverage and obtain pre-authorization for procedures and services as required by insurance providers.Communicated with insurance companies to resolve any issues related to patient benefits and coverage.Accurately entered patient information into the hospitals information system, ensured all data was complete and up-to-date.Maintained confidentiality and security of patient information in compliance with HIPAA regulations and hospital policies.EDUCATIONMASTER OF SCIENCE ~ HEALTH SERVICES ADMINISTRATION (2014)Strayer UniversityBACHELOR OF ARTS ~ LIBERAL ARTS (2009)Texas Southern UniversitySOFTWARE SKILLSProficient in various clinical and regulatory software including Domasys, Ecollabora, Starting Point, Star, Epic, EndNote, CTMS, Medi-Tech, McKesson, PeopleSoft, ImageNow, Intralinks, Documentum, VEEVA, Please Review, ProQuest, PubMed, Medline, Embase, and the Microsoft Office Suite.PROFESSIONAL AFFILIATIONSDrug Information AssociationAmerican Medical Writers AssociationRegulatory Affairs Professional SocietyEuropean Medical Writers Association |
