Technical Writing Specialist

Summarized Purpose :

Assists in the coordination and preparation of basic scientific documents under direct supervision. Responsible for preparing and editing scientific documents to meet or exceed quality standards. Assists in the design, preparation and review of analytical protocols for validation or analytical studies. Essential Functions and Other Job Information : Essential Functions

• Prepares and/or assists in the preparation of scientific documents such as next time point creates or other basic shell creation. Ensures that hardcopy and electronic reports are consistent and comply with required formats. Reviews data tables and listings and ensures that errors are corrected. Edits and performs a quality control review of scientific documents prior to creation of the final pdf deliverable. Ensures compliance with PPD, Client, eCTD policy and procedure on publications.

• Reviews technical documents for accuracy, formatting, consistency and compliance to protocols or SOPs.

• May represent the laboratory on project teams and update team members on the status of study reports. Acts as a liaison on interdepartmental projects when reports are required.

• Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents. May help write Training Materials Documents and Standard Operating Procedures related to Scientific Writing functions.

• Works with more senior staff on approach for new assignments.

• Performs other duties as assigned.

Job Complexity

Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice.

Job Knowledge

Applies acquired job skills and company policies and procedures to complete assigned tasks.

Supervision Received

Normally follows established procedures on routine work, requires instructions only on new assignments.

Business Relationships

Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation.

Qualifications :
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, & experience.
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills and Abilities :

• Working knowledge of scientific terminology, medical, pharmaceutical and research concepts

• Knowledge of word processing, spreadsheets, table and graph generation

• Effective written and oral communication skills

• Detail oriented

• Computer skills including Microsoft Office

• Time management skills

• Good editorial and proofreading skills

• Problem solving and troubleshooting abilities

• Ability to work well in a collaborative team environment

Management Role :

No management responsibility

Working Conditions and Environment :

• Work is performed in a clinical environment.

• Exposure to biological fluids with potential exposure to infectious organisms.

Physical Requirements :

• Frequently stands, twists waists, squats, and bends neck for 4--6 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects.

• Frequent mobility required.

• Occasional crouching, stooping, bending and twisting of upper body and neck.

• Moderate lifting (or otherwise movement, carrying, setting, and placement)of 15-30 lbs. with a maximum lift of 35 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.

• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance.

This document is intended to describe the general nature and level of work being performed by this job. This document is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Individual responsibilities will be defined by your leadership team and will vary based on business needs.