PROFESSIONAL EXPERIENCE

Senior Technical Writer 

Confidential

Responsibilities:

• Research, create, and edit new or existing documentation for process alignment.
• Collaborated with other writers and various stakeholders (GCP, GMP) responsible for documents.
• Track project plan dates and update accordingly to keep the schedule.
• Managed documentation in Veeva, documents in Word and meetings in MS Teams or Zoom.

Senior Technical Writer 

Confidential

Responsibilities:

• Researched, wrote, and edited new or existing documentation for a new GMP manufacturing plant.
• Collaborated with Engineering, Manufacturing, Quality, Marketing and Regulatory groups.
• Managed documentation in Veeva, documents in Word and meetings in MS Teams or Slack.

Senior Technical Writer

Confidential

Responsibilities:

• Created and revised new or existing documents for scientists.
• Assisted scientists and lab personnel with formatting documents for consistency.
• Managed documentation and version control with MS Teams and SharePoint.
• Documents written using MS Word and Adobe Pro.

Senior Technical Writer

Confidential

Responsibilities:

• Created and revised documents for products with strict deadlines in the manufacturing department.
• Used Veeva for document control, and MS Word for writing documentation.

Senior Technical Writer

Confidential

Responsibilities:

• Created various document types using pre-designed or newly formatted templates.
• Used ENSUR, an in-house eDMS system, and MS Word.

Senior Technical Writer

Confidential

Responsibilities:

• Created documents based on customer and manufacturing needs.
• Used an excel spreadsheet for document version control.
• Documents written in MS Word. MS Teams for meetings, and SharePoint for document control.

Senior Technical Writer

Confidential, Watertown, MA

Responsibilities:

• Reviewed, edited, and created documents used by the IT Help Desk.
• Established and monitored Confluence spaces for different organizations as requested.
• Communicated with various document owners to train or to assist with documentation.
• Created templates for various document types used within the business.
• Interviewed staff when writing documentation to ensure proper description of practices.
• Documents written with MS Word. MS Teams used for collaboration meetings.

Senior Technical Writer

Confidential, Cambridge, MA

Responsibilities:

• Ensured documentation adhered to FDA/EU regulations and GxP.
• Submitted documents to SMEs and Quality for version control.
• Alerted all appropriate personnel as deadlines approached to ensure timely document releases.
• Documents written in MS Word. Communicated with MS Teams and Outlook.

Senior Technical Writer

Confidential, Lexington MA

Responsibilities:

• Interacted with SMEs and Process Owners to develop and update working documents for various functional areas: Global Drug Safety (Pharmacovigilance), Quality Assurance & Compliance, Records Management, Business Continuity Plans, Governance, Compliance Monitoring, and Compassionate Use.
• Collected input from a variety of stakeholders and contributed to document updates and tracking.
• Organized document reviews, consolidated comments, and conducted collaboration meetings.
• Followed GxP requirements for all processes as well as adherence to FDA/EU regulations.
• Products used: MS Office Suite (Word, Excel, Visio), Adobe Acrobat, SharePoint, Master Control, Please Review, Veeva, and MS Teams.

Senior Technical Writer

Confidential, Waltham MA

Responsibilities:

• Interviewed SMEs to define functions, product configurations, connectivity, and user information.
• Ensured FDA required document standards for all manuals.
• Products used: MS Word and Adobe Products (InDesign, FrameMaker, Acrobat) on a Mac and PC Platform.

Senior Technical Writer

Confidential, Bedford MA

Responsibilities:

• Conducted interviews to define workflows to log into Seapine Tracking Software.
• Responsible for all documents being entered into the tracking system.
• Responsible for all training related to Seapine Documentation.
• Edited Word documents for clarity.
• Products used: MS Word and Adobe Products (InDesign, Acrobat). PC and Mac Platforms.

Technical Writer

Confidential, Watertown MA

Responsibilities:

• Wrote instruction for various processes used in online publishing.
• Acquired basic HTML coding skills (Jira, Confluence) for performing tasks.
• Products used: MS Office Suite, Java, Scrum/Agile methodologies.

Technical Writer

Confidential, Boston, MA

Responsibilities:

• Presented draft documents for SME reviews.
• Distributed final documents to the Project Manager.
• Documents written with MS Word.

Technical Writer

Confidential, Waltham, MA

Responsibilities:

• Compiled a record of all received materials.
• Followed FDA requirements to ensure compliance between work performed and documentation.
• Compiled list of all vendors to show documentation status requirements and inspection history.
• Documents written with MS Word.

Technical Writer

Confidential, Canton, MA

Responsibilities:

• Worked directly with field engineers on report coordination and approval.
• Followed strict schedules to ensure compliance.
• Enhanced current templates for ease of use.
• Recorded and tracked all documentation for audit purposes.
• Documents written with MS Office Suite (Word and Excel).

Technical Writer - Contractor

Confidential, Quincy, MA

Responsibilities:

• Produced documents by observing test processes and interviewing SMEs.
• Translated technical information and business requests into user-oriented procedural documents.
• Facilitated document review meetings with various functional teams.
• Followed GMP requirements for FDA regulations.
• Documents written with MS Word.

Technical Writer

Confidential, Weston, MA

Responsibilities:

• Collaborated with business analysts to create a streamlined documentation process.
• Member of Safety Awareness Team.
• Followed GxP requirements and FDA/HIPAA regulations.
• Documents written with MS Word.

Technical Writer

Confidential, Raynham, MA

Responsibilities:

• Performed validation testing and analysis on documented procedures and data.
• Adhered to GMP and validation requirements for FDA regulations.
• Documents written with MS Word. Also used MS Excel.

Technical Writer/Trainer

Confidential, Boston, MA

Responsibilities:

• Assisted with unit tests for accounting and scheduling software.
• Assisted with IT testing by developing scenarios for quality performance.
• Conducted training classes as needed.
• Followed GMP requirements.
• Documents written with MS Word.

Technical Writer

Confidential, Lexington, MA

Responsibilities:

• Evaluated scheduling process functionality for accounting, posting and claim procedures.
• Collaborated with business analysts, developers, and Quality Assurance personnel.
• Resolved QA documentation issues.
• Adhered to HIPAA regulations as well as GMP and validation requirements for FDA regulations.
• Documents written with MS Word.

Senior Technical Writer/Documentation Lead

Confidential, Boston, MA

Responsibilities:

• Collaborated with SMEs, business analysts, software developers and nurses.
• Reported on or explained the document process flow status during the software development life cycle.
• Edited XML documents related to online help submission to developers.
• Documents written with Adobe FrameMaker.

Technical Writer

Confidential, Norwood, MA

Responsibilities:

• Wrote call center software training manuals for customer support personnel.
• Participated in training classes to witness presentation and ensure documentation quality.
• Documents written using MS Word.

Technical Writer

Confidential, Hopkinton, MA

Responsibilities:

• Created software documentation from product release specifications using a Microsoft platform.
• Completed six user manuals, including the creation of two new manuals and on-line help instructions.