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Click here or scroll down to respond to this candidateJUNE 2024Candidate's Name
Email: EMAIL AVAILABLEPhone: PHONE NUMBER AVAILABLEHarrisburg, PALinkedIn: Candidate's Name LinkedInPROFESSIONAL SUMMARYAs a seasoned technical writing and editing specialist, I bring 19 years of experience in crafting clear, concise, and impactful documents across diverse sectors. My portfolio includes reports, policies, regulatory submissions, permit applications, and funding requests. I excel at collaborating with cross-functional teams to deliver top-notch content while optimizing resources for cost-effectiveness. My background extends beyond technical writing, encompassing project management, business development, financial analysis, quality control, product development, customer relations, legal matters, marketing, and grant writing. These multifaceted skills were honed during my tenure as a municipal civil engineer and as a purchasing assistant and production scheduler in the hand-blown glass manufacturing industry.I am a dedicated team player who consistently strives for excellence, using my experience to create high- quality deliverables fit for purpose. Lets connect and discuss how I can contribute to your organizations success.SKILLS: Strong Writing Skills: Excellent at conveying complex information clearly and concisely. Adaptability: Well-versed in tailoring communication styles effectively for diverse audiences, including clinical professionals, regulators, and laypeople. Research Abilities: A solid background in literature research enables efficient gathering of accurate and relevant information with little direction and guidance. Attention to Detail: Adept at catching errors, inconsistencies, and inaccuracies in documents. Familiarity with FDA Regulations: Possess a general knowledge and understanding of regulatory guidelines related to clinical trial submissions and other electronic common technical documents. Data Analysis: Proficiency in analyzing and interpreting data (i.e., SAS, WNL, R). Software Proficiency:Microsoft Word (Expert)Adobe Pro (Expert)Microsoft PowerPoint (Average)EXPERIENCE: Managing Writer & Editor OwnerTechnical TechniqueJan 2019PresentHarrisburg, PAExperienced technical writing expert who specializes in crafting high-quality materials for businesses and individuals. Some of the methods used to elevate client's documentation include: Client-Centered Approach: Listening to client needs to ensure that final documents align with their goals. Whether it is reports, policies, or regulatory submissions, services are tailored to meet your unique requirements. Audience-Driven Content: Excellent at tailoring the writing style and other attributes to suit the intended audience, showcasing your accomplishments or relevant highlights to emphasize the value you bring to clients. From permit applications to funding requests, we turn complex information into compelling narratives. Solutions-Oriented: Providing a breakdown of intricate processes to step-by-step instructions. Whether it is a manual, how-to guide, or project proposal, it can be made accessible and actionable.Candidate's Name
Experienced Technical WriterPage 2 of 5EXPERIENCE: Manager, Medical WritingAmador Bioscience, Inc.Oct 2020May 2024Harrisburg, PAProject Management: Developed, maintained, and proactively tracked Clinical Pharmacology, Bioanalytical, and Regulatory Affairs projects. Authored and reviewed Pharmacology Reports, Immunogenicity Reports, and Investigational New Drug applications. Coordinated complex narrative projects, ensuring high-quality deliverables. Prioritized and managed multiple assignments independently. Submission-Level Expertise: Prepared eCTD submission-ready documents, adhering to industry standards. Oversaw the management of critical project timelines and budgets. Scientific Communication and Leadership: Produced and edited scientific papers, abstracts, posters, and presentations. Mentored and guided fellow medical/technical writing staff. Represented the Medical Writing department during audits and inter-departmental collaborations.Quality Assurance and Compliance: Ensured adherence to Amador Standard Operating Procedures, client specifications, and relevant ICH guidelines. Reviewed SOPs and associated documents for accuracy and consistency. Contractor, Medical WritingAmador Bioscience, Inc.Mar 2019Oct 2020Harrisburg, PACoordinated closely with internal Amador Bioscience teams and external stakeholders to deliver superior-quality reports, regulatory submissions, and other critical documents. Ensured timely delivery while maintaining the highest standards of quality. Project ManagerGannett FlemingSept 2007Aug 2013Harrisburg, PAWater System and Sewage Facilities Planning: Prepared comprehensive studies on water system planning and sewage facilities. Translated technical details into accessible reports, ensuring clarity for stakeholders. Infrastructure Recommendations: Modeled distribution and collection systems, providing valuable insights for infrastructure upgrades. My recommendations influenced project design and implementation. Financial Assistance and Compliance: Compiled and submitted financial assistance applications, demonstrating attention to detail. Managed loan and grant administration, ensuring compliance with regulations. Technical Writing and Documentation: Developed permit applications, adhering to industry standards. Created Bid Specifications in Construction Specifications Institute Format. Self-edited correspondence and other critical documents. Project Coordination and Tracking: Used scheduling software to plan and track project milestones. Prepared Engineers Estimates, contributing to accurate budgeting. Quality Assurance and Feasibility Review: Reviewed plans prepared by others, ensuring compliance with local requirements. Assessed design feasibility, maintaining high standards. Candidate's Name
Experienced Technical WriterPage 3 of 5Assistant Project ManagerDavis, Bowen, & Friedel, Inc.Oct 2004Sept 2007Salisbury, MDTechnical Writing and Documentation: Authored engineering and environmental reports, ensuring clarity and accuracy. Reviewed project plans, providing valuable insights during plan reviews. Water Resources and Sanitary Engineering: Contributed to water resources design and sanitary engineering projects. Applied expertise to enhance project outcomes.Stakeholder Engagement and Project Management: Conducted meetings with clients, developers, and contractors. Managed project administration, ensuring seamless execution. Funding and Compliance: Prepared permit, grant, and funding applications. Compiled and reviewed project documents, maintaining quality standards. Project Specifications: Wrote and reviewed project specifications, aligning with industry requirements. Various Part-time Positions in Support of Continued EducationApr 2000Sept 2004Weston, WVPurchasing and SchedulingPrincess House ManufacturingJan 1998Mar 2000Weston, WVAs a Manufacturing Operations Specialist in the high-volume hand-blown glassware division of a direct sales company, I played a pivotal role in ensuring seamless day-to-day operations.Production Scheduling and Coordination: Developed and managed production schedules, optimizing efficiency and meeting customer demands. Coordinated with cross-functional teams to ensure timely delivery of glassware products.Order Processing and Documentation: Processed customer orders accurately, maintaining meticulous records. Created and updated order-related documentation, ensuring clarity and compliance. Material Handling and Quality Control: Oversaw material inventory, minimizing waste and maximizing resource utilization. Conducted quality checks to maintain product standards. Contract Reviews and Compliance: Reviewed contracts, identifying critical terms and conditions. Ensured adherence to contractual obligations, mitigating risks. Budget Development and Catalog Line Expansion: Collaborated with the Production Manager to create an annual budget exceeding $1 million. Help to launch an independent catalog line, resulting in annual sales of over $50,000. My attention to detail, organizational skills, and ability to communicate effectively were essential in achieving operational excellence.Program ManagerRes-Care Community Alternatives WVJun 1997 Mar 1998Buckhannon, WVRegional Intermediate Care Facilities and Assisted Living Programs dedicated to facilitating independence in mentally challenged adults. Implemented programs supporting daily living and personal care goals. Directed three to four mentally challenged adults in completing goals. Candidate's Name
Experienced Technical WriterPage 4 of 5Program ManagerTime Warner Cable1997--1997Buckhannon, WVAs a dedicated professional in the in-home entertainment and communications industry, I contributed significantly to enhancing customer experiences. Managed changes to an existing database, ensuring data accuracy and efficiency. Streamlined processes, improving system performance. Successfully reprogrammed cable converters, resolving technical issues promptly. Created user-friendly guides for troubleshooting, and enhancing customer self-help resources. Collected and analyzed customer satisfaction data, identifying trends and areas for improvement. Authored reports summarizing findings, providing actionable insights to management. My commitment to clear communication and problem-solving directly impacted customer care.Field SupportBreckenridge Corporation1994--1997Buckhannon, WVAs a general contractor specializing in industrial construction, I focused on critical projects related to water/wastewater treatment plants, concrete structures, and the reclamation of abandoned mine lands.Bid Development Support: Assisted in bid preparation, ensuring accuracy and competitiveness. Collaborated with the team to create compelling proposals. Material Handling and Logistics: Managed material handling processes, optimizing efficiency. Ensured timely delivery of construction materials. Financial Administration: Handled Accounts Payable tasks, maintaining financial records. Contributed to cost control and budget management. Asset Control Program Implementation: Designed and implemented an asset control program. Tracked equipment and resources, enhancing operational efficiency. Assistant Store ManagerLane Bryant Inc.19931994Ithaca, NYResponsible for ongoing daily operations including cash management, recruitment, and training of sales associates, the development of local marketing packages and ongoing customer support.Part-Time Sales AssociateLane Bryant Inc.19921993Elmira, NYResponsible for customer service, sales, and other day-to-day operations duties at a retail clothing chain owned and operated by The Limited, Inc. Habilitation SpecialistSchuyler ARC19911992Watkins Glen, NYOffering person-centered support to individuals with intellectual and developmental disabilities in a home environment. The role involved creating opportunities for clients to gain essential life skills, fostering meaningful relationships, and promoting independence. Including help with daily activities of eating, bathing, and dressing. Candidate's Name
Experienced Technical WriterPage 5 of 5EDUCATION: Fairmont State CollegeBS Civil Engineering Technology Environmental EmphasisAugust 2003 Fairmont, WV West Virginia Wesleyan CollegeBA Elementary EducationMay 1991 Buckhannon, WVPROFESSIONALDEVELOPMENT: Introduction to GLP/GCLP TrainingMeridian BioGroup 23 June 2023 Introduction to Regulatory WritingThe University of Chicago Graham School, Oct 2022 Principal Investigator TrainingMeridian BioGroup, 9 Feb 2021 Writing in the Sciences (Certificate)Stanford University on Coursera.com, Nov 2019 CERTIFICATES &LICENCES:Engineer In Training Certificate West VirginiaIssue Date: 06/01/2007 |
