Technical Writing Project Management

JUNE ****

ROULETTA A. BLOWERS

Email: ********.*********@*****.***

Phone: 717-***-****

Harrisburg, PA

LinkedIn: Rouletta Blowers LinkedIn

PROFESSIONAL SUMMARY

As 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. Let’s connect and discuss how I can contribute to your organization’s 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 Owner

Technical Technique

Jan 2019—Present

Harrisburg, PA

Experienced 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.

Rouletta A. Blowers

Experienced Technical Writer

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EXPERIENCE: Manager, Medical Writing

Amador Bioscience, Inc.

Oct 2020—May 2024

Harrisburg, PA

Project 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 Writing

Amador Bioscience, Inc.

Mar 2019—Oct 2020

Harrisburg, PA

Coordinated 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 Manager

Gannett Fleming

Sept 2007—Aug 2013

Harrisburg, PA

Water 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. Rouletta A. Blowers

Experienced Technical Writer

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Assistant Project Manager

Davis, Bowen, & Friedel, Inc.

Oct 2004—Sept 2007

Salisbury, MD

Technical 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 Education

Apr 2000—Sept 2004

Weston, WV

Purchasing and Scheduling

Princess House Manufacturing

Jan 1998—Mar 2000

Weston, WV

As 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 Manager

Res-Care Community Alternatives WV

Jun 1997 – Mar 1998

Buckhannon, WV

Regional 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. Rouletta A. Blowers

Experienced Technical Writer

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Program Manager

Time Warner Cable

1997--1997

Buckhannon, WV

As 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 Support

Breckenridge Corporation

1994--1997

Buckhannon, WV

As 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 Manager

Lane Bryant Inc.

1993—1994

Ithaca, NY

Responsible 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 Associate

Lane Bryant Inc.

1992—1993

Elmira, NY

Responsible for customer service, sales, and other day-to-day operations duties at a retail clothing chain owned and operated by The Limited, Inc. Habilitation Specialist

Schuyler ARC

1991—1992

Watkins Glen, NY

Offering 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. Rouletta A. Blowers

Experienced Technical Writer

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EDUCATION: Fairmont State College

BS Civil Engineering Technology Environmental Emphasis—August 2003 Fairmont, WV West Virginia Wesleyan College

BA Elementary Education—May 1991 Buckhannon, WV

PROFESSIONAL

DEVELOPMENT:

• Introduction to GLP/GCLP Training—Meridian BioGroup 23 June 2023

• Introduction to Regulatory Writing–The University of Chicago Graham School, Oct 2022

• Principal Investigator Training–Meridian BioGroup, 9 Feb 2021

• Writing in the Sciences (Certificate)–Stanford University on Coursera.com, Nov 2019 CERTIFICATES &

LICENCES:

Engineer In Training Certificate West Virginia

Issue Date: 06/01/2007

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