Randstad Technical Writer in Cambridge, Massachusetts
salary:$25 - $28.70 per hour
date posted:Friday, June 1, 2018
Job Title: Technical Writer II
Standard Operating Procedure Technical Writer for Pharmaceutical SciencesThe Writer is responsible for and participates in a project involving the revision of existing standard operating procedures (SOPs) and development of associated documents to effectively meet operational and regulatory requirements of Takeda. Writer will work with subject matter experts in Pharmaceutical Sciences on relevant topics and be responsible for revision of GxP procedures based on subject matter input.
Onsite or partial remote
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.
Draft process maps to illustrate process flow as it relates to the procedures
Draft job aids, templates, and/or training materials to accompany GxP procedures
Works directly with R&D Documentation group for review and approval of SOPs and associated documents in Takeda's quality documentations system
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.
Perform other related duties and special projects, as needed
Bachelor's Degree required
Minimum 3 years' experience writing/formulating policy and procedure documentation in the biotech or pharmaceutical field (background in GMP requirements highly preferred)
Excellent writing, editing, proofreading, and process mapping skills
Excellent written and verbal communication skills, with the ability to communicate and interact effectively with all levels of personnel.
Advanced software proficiency in MS Word, Excel, PowerPoint, Outlook, and other software applications, such as Visio, and Adobe Acrobat Pro, used in performance of job duties.
Ability to perform multiple tasks and meet critical deadlines, while maintaining accuracy and quality.
Compose materials such as detailed reports, work-related manuals, publications of large scope or impact, and create presentations associated with job duties.
Understand complex problems, and to collaborate and explore alternative solutions.
Work in a fast-paced environment on large and small projects, with changing priorities.
Maintain strict confidentiality and discretion.
Effective decision-making skills, sound judgment, and strong technical aptitude.
Strong organization and analytical skills, with strong attention to detail.
Strong self-starter and self-motivator, with the ability to work autonomously.
Service and team oriented.
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance