Technical Writer - II

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Svaldi.

Position: Technical Writer

Location: Remote

Duration: 3 Months

Job Type: contract

Work Type: Remote

Job Description:

• Technical Writer will support the development of procedural documents, communications, and training materials for the Clinical Data Science (CDS) organization.

Responsibilities

• Reviews and edits controlled procedural documents (SOPs, manuals, forms, templates, checklists, etc.)

• Reviews and edits department communications and/or training materials related to PD updates

• Ensures that documents are technically and mechanically accurate and consistent with regard to clarity, flow, organization, completeness, level of detail, formatting and readability across the entire document and across similar documents

• Verifies own work and ensures compliance to internal style guides and templates

• Drives content development for PDs through discussion with subject matter experts, aggregates information and summarizes coherently

• Tracks feedback, review comments, and document updates

• Tracks and manages multiple concurrent document updates including statuses, timelines, action items, and other relevant documents

Knowledge and Skills

• Demonstrated ability to perform highly detail-oriented work in reviewing and editing procedural documents with high degree of accuracy and efficiency

• Strong proficiency with MS Word required, experience with document management systems and MS Office tools (Outlook, Excel, PowerPoint, Visio, etc.) preferred

• Demonstrated strong verbal, written, and interpersonal communication skills

• Demonstrated ability to work independently with accuracy review draft documents, resolve comments and provide feedback

• Demonstrated ability to complete high quality work on multiple concurrent projects under tight deadlines

• Knowledge of drug development processes and the GxP quality framework consisting of Standard Operating Procedures (SOPs) and related procedural documents (PDs) preferred

• Prefer experience working in Biometrics

Education and Experience

• 5 years of relevant experience and a BA or BS

• Experience within a pharmaceutical/biotechnology organization is preferred

• Data Science or Biometrics experience a plus

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.