Responsibilities for the Technical Writer• Write SOPs, Work Instructions, Guidance Documents, Batch Records and other engineering and manufacturing documents
• Proofread and modify documents into a clear and presentable form
• Work within the Document Control system to create, submit and release documents
• Attend meetings and communicate with engineers as required to take technical concepts and translate them into a written format
• Adhere to project schedules in completing assignments

Requirements for the Technical Writer

• Bachelors of Arts in Technical Writing, English or related field
• 3-5 years experience in technical writing utilizing the Microsoft Office Suite of products especially Word and Publisher
• Strong computer skills to create or transfer images, diagrams, tables, into documents.
• Experience in releasing technical documents in a controlled system

Benefits

RESPONSIBILITIES:

Kforce has an Enterprise Level Technology Client in Roseville, California (CA) requiring a Management of Change Communications/Copy Writer to support their Global Supply Chain team.

Summary:
The ideal candidate will have mid-senior level experience and will focus on Developing and managing internal and external communications program in support of Global Supply Chain business objectives. This person will support the business by driving execution of the communication strategy in alignment with the overall strategy and priorities. The individual in this role will provide external communications, including written announcements, videos, presentations, keynotes, social media content, etc. They may participate in cross-division, multi-function teams. The individual routinely exercises independent judgment in developing methods, techniques and criteria for achieving objectives.

REQUIREMENTS:

• Bachelor”s degree in Communications/Marketing or equivalent
• Prefer a candidate with Supply Chain experience

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.

• Home-based position

• Part-time – 20-25 hrs / wk

• ELS (Editor in Life Sciences) preferred not required

• 5+ years clinical/regulatory document review including clinical manuscripts

Description :Effectively reviews documents created within or outside of the company to ensure quality of a standard that meets or exceeds client”s expectations. Documents include: regulatory submissions, integrated clinical study reports, serious adverse event narratives, study protocols and publications. Ensures integrity of data in tables against source documents. Instructs others outside of the quality review group on the review process.
Essential Functions:

• Reviews highly technical documents of all types created within or outside of the company to ensure quality standard that meets or exceeds client”s expectations

• Ensures scientific logic and clarity of the document by verifying data in tables

• against source documents, checking for consistency according to current regulatory standards and guidelines

• Edits for accuracy, consistency and grammatical correctness

• Adjusts schedule to accommodate unexpected requests for priority review

• Revises scientific language for usage, flow, clarity, and audience appropriateness

• Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment

• Maintains, communicates and applies knowledge of current guidelines, templates

• and industry standards

• Coordinates the work of team members and tracks the status of documents being reviewed

• May represent the department at meetings with clients

• Contributes to the development and modification of the quality review process

• Collaborates with the writer to manager alliance account(s)

• Delegates weekly assignments to the quality review team and fields questions as appropriate

• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors

• Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise

Education and Experience :

• Bachelor”s degree or equivalent and relevant formal academic / vocational qualification

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years”)

• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role

• Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document”s message

• Thorough knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g. ICH), and requirements of the FDA and other international regulatory agencies

• Familiarity with interpreting data and excellent analytical ability

• Effective oral and written communication skills

• Good organizational and planning skills

• Good interpersonal skills

• Ability to work on own initiative

• Good computer literacy and expertise

• Competent word processing skills

• Solid understanding of document management systems

• Suitable level of expertise within a broad range of medical writing projects

• Good knowledge of global and regional medical writing and regulatory affairs duties for clinical trials, marketing authorization and late-phase procedures

• Capable of providing general advice and training to others

• Capable of working well under pressure and remaining motivated

• Capable of working both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment