Technical Writer III

SUMMARY

The Technical Writer III independently prepares, revises and reviews contract service deliverables for all service areas, including atypical designs and formats. This role is responsible for working with internal and external clients to determine what content should be included in deliverables, training employees at or below their level and maintaining/updating various documents, templates and procedures.

This position will ensure compliance with Environmental Health and Safety (EHS) policies, State Departments of Health, Good Documentation Practices (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), EMEA and FDA Guidelines, general State and Country Regulations such as but not limited to (CLIA, CAP, USP, ISO 9001, USDA regulations, HTA license, DEA and State Controlled Substance programs) where site appropriate.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Responsible for preparing accurate deliverables for all service types (including atypical designs and formats) that meet management-established quality and timeline standards, following internal and external style guides and requirements.
• Responsible for coordinating preparation, revision and finalization of contract service reports, including scheduling.
• Responsible for communicating with internal clients to determine deliverable content and timelines and sending accurate deliverables to internal clients by agreed upon deadlines.
• Responsible for accurately designing and maintaining templates for all service types (including sponsor specific designs and formats) that meet management-established quality and timeline standards, following internal and external style guides and requirements. Responsibility includes maintaining up to date sponsor requirements for client deliverables and ensuring sponsor-specific templates reflect those requirements.
• Responsible for advising internal clients on documentation standards and best practices. Responsibility includes coordinating and leading meetings and communication ensuring interdepartmental standardization.
• Responsible for training technical writers at or below level according to training plans and company expectations and standards. Responsibility includes reviewing and QCing deliverables written by technical writers for requirements (internal and external) and accuracy.
• Responsible for keeping accurate administrative records.

TELECOMMUTING REQUIREMENTS (if applicable):

While telecommuting, the employee is required to have a designated, in-home workspace and reliable internet connection.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

• MA/MS +2 y experience or BA/BS +4 y experience or equivalent combination of experience and education.
• Prior experience in scientific terminology and data generated in a laboratory environment essential.

Other Skills and Abilities

• Expert in Microsoft Word, Adobe Pro, use of templates, establishing navigation in large documents, aligning to style guides.
• Proficient in a variety of computer software programs including MS excel, graphic and statistical analysis applications. Ability to learn new software programs.
• Excellent organization and time-management skills with high attention to detail.
• Ability to read, analyze, interpret, and write documents such as email correspondence, safety rules, operating and maintenance instructions, procedure manuals and regulations.
• Exceptional problem-solving, analytical, and critical thinking skills, with the ability to adapt to new challenges quickly.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be required to: stand; walk, sit, stoop, kneel, crouch, crawl, speak, hear/listen, smell, display manual dexterity, reach with hand and arms. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus. The employee must frequently lift and/or move up to 1 pound and occasionally lift and/or move up to 20 pounds.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Full-time Monday through Friday workweek with general business hours and flexibility to occasionally work additional hours as needed and approved by management. While performing the duties of this job, the employee will be working in professional office, or home office environment using standard office equipment.

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. All job requirements are subject to modification to reasonably accommodate individuals with disabilities. Continued employment remains on an at-will basis, unless otherwise contractually bound.