RESPONSIBILITIES:

Kforce has a client in search of a TrackWise Technical Writer in Lexington, Massachusetts (MA).

Primary Duties

• Under the direction of the line manager, the Contract R&D Pharmaceutical Development Documentation, Training and Compliance Specialist is responsible for supporting all the documentation and training needs
• Attend team meetings to become familiarized with end users” needs
• Solicit feedback from Centers of Excellence (CoEs)
• Write TrackWise manual for first time users
• Create training materials for first time users
• Assist with training and documentation projects

REQUIREMENTS:

• Bachelor”s degree required
• Minimum 1 year of experience is required
• Experience in Biopharmaceutical industry is preferable
• Documentation experience required (paper-based and as well as electronic system)
• Training system experience required (paper-based and as well as electronic system)
• Excellent written English with good a sense of style (simple language and straightforward tone)
• Ability to quickly learn ins and outs of a software product without previously created training or documentation
• Great attention to detail
• Self-starter with ability to work without much managerial oversight
• Prioritization decisions will be made by line manager
• Able to solve problems and escalate issues to line manager

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Chat with me now! – https://flashrecruit.com/jobs/300199

Job Title: Technical Writer V

Position Description

• Under limited supervision, the Writer is responsible for and participates in projects involving the revision of existing SOPs or development of policy and procedure documents to effectively meet operational and regulatory requirements of the company. Performs related regulatory compliance research, analysis, and evaluation activities, as needed. Acts as a project leader for all related work as the SOP designer.

Position Responsibilities

• Interviews subject matter experts (SMEs), observes work processes, and communicates with business leaders and staff to research and analyze information required for the development, update, or consolidation of policies, procedures, forms and/or training documents
• Develops documents in accordance with Company standards and templates.
• Prepares, packages, and presents draft documentation to management, compliance/risk, subject matter experts, and appropriate lines of business for review and publication approval.
• Drafting process maps to illustrate process flow as it relates to the procedures
• Works with Quality Document Management team to secure, assemble, and archive accumulated documentation and approvals for regulatory compliance purposes.
• Acts as a project leader in all phases of project execution and implementation, and ensures all related objectives are fulfilled
• Conducts and attends all relevant meetings associated with job function, and completes tasks correctly and on time.
• Maintains cohesive working relationships with SMEs, management, vendors/CROs, and team to effectively interface on all projects and deliverables.
• Follows the Company”s policies and procedures and supports the Company”s Core Values.
• Travels to company site to meet with Subject Matter Experts, as needed.
• Perform other related duties and special projects, as needed

Position Requirements

• Onsite or Remote
• Bachelor”s Degree required; health care professional preferred
• Education, Behavioral Competencies and Skills
• Minimum 3 years” experience in Pharmacovigilance/Patient Safety (preferred experience in Case Processing and Risk Management).
• Minimum 3 years” experience writing/formulating policy and procedure documentation in the biotech/pharmaceutical areas.
• Demonstrated experience performing regulatory compliance research and analysis using industry standard tools, and the ability to develop comprehensive policy and procedure documentation in accordance with regulations
• Excellent writing, editing, proofreading, and process mapping skills

Benefits

• Medical, Dental, and Vision Insurance
• 401K Plan with Company Match
• Life and AD&D Insurance

Chat with me now! – https://flashrecruit.com/jobs/300199