We are looking for a Technical Writer for the Houston, TX area. As part of the Technical Communications team, you will update and produce operating and maintenance information products with relevant experts. You will support various engineering team project teams, facilitating the creation and update of high quality and accurate technical documents.

Responsibilities:

• Create, update and maintain technical reference, operational and maintenance content for use by field engineers & technicians by working closely with project development team.
• Write structured documentation in a content management system that maximizes comprehension and ease of use. (Arbortext Editor is the authoring tool.)
• Edit documents supplied from subject matter experts according to corporate standards, style and Simplified Technical English
• Obtain source information from internal project documentation sources and interviews with project team members as well as from change request tickets.
• Manage review cycles and incorporate review comments
• Be familiar with working with graphics such as cropping photos and editing vector line art e.g. adding callouts to an illustration.
• Collaborate and help subject matter experts provide their source content in the best possible way, which may involve writing tips training or other ways to improve the source content.
• Responsible for managing company documents while also ensuring their accuracy, quality and integrity.
• Document day to day operations into accordance with company procedures for receipt and distribution of documents.
• Process engineering documents to ensure accuracy and timeliness of distribution.
• Accountable for quality assurance and quality control on all project to be delivered to the business
• Classify new technology as defined by the Technology Engineers.
• Gather requirements for projects and Technical Documentation,
• Have clear understanding of the impact of Technical Documentation.

Experience:

• Excellent technical writing and editing skills in a content management, structured authoring environment
• Must have experience documenting technology software processes
• Required to produce high quality user documentation to agreed corporate standards and timescales, which comprises mostly of maintenance procedures.
• Content is typically delivered to corporate business systems either as XML or PDF for project deliverables or as part of update cycles
• 4 years” experience writing Standardized Work Instructions (SWI).
• Aerospace or Airline industry experience highly preferred, not required
• Associates Technology degree
• Project coordination experience.
• Understanding of Project Development Life Cyle
• Experience with 3D modeling (used when writing SWI, is a plus

• Experience in scientific manuscript writing
• Understands clinical data sets
• 10+ years of experience
• PhD, MD, MS, Pharm D type credentials 
• Associate Director GCF band
• Understands R&D and Commercial
• Must have extensive experience writing Manuscripts

Responsibilities for the Technical Writer• Create, define, or modify templates or style sheets (for both online and traditional publishing) using available authoring tools and in compliance with corporate branding standards and directives.
• Provide training to writers and other team members in the use of templates, tool setup, and template compliance.
• Document individual workflow as required when using new tools and coordinate the approval and publishing of work flows and detailed procedures with technical writing lead.

Requirements for the Technical Writer

• Bachelor”s Degree in engineering field with 5+ years of experience; alternatively, a special combination of education and experience and/or demonstrated accomplishments.
• Working knowledge of upstream oil and gas hardware and software including, but not limited to, flow computers, remote terminals, instrumentation devices, and communication protocols.

Benefits

• 401K
• Health Insurance

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

About the Company

Our client, a Pharmaceutical company focused on the discovery of small molecule drugs for the treatment of viral infections and liver diseases, is currently seeking a Medical Writer to join their team. This is an exciting opportunity to join a growing company with a sold pipeline and room for advancement.

Job Description

The Medical Writer will be responsible for medical writing projects that support the clinical portfolio. Key responsibilities include:

• Assisting in preparing moderately complex clinical study documents (clinical study protocols/amendments, clinical study reports, investigator’s brochure), abstracts/manuscripts and sections of regulatory submissions necessary for early phase clinical drug development.
• Drafting, editing, formatting, and finalizing above mentioned documents in coordination with Clinical/Regulatory. Other documents may include health authority briefing books, and scientific publications, abstracts/presentations
• Providing QC of clinical and regulatory documents including data output
• Ensuring scientific consistency between related documents or studies in a clinical program
• Facilitating efficient review and finalization process of documents produced internally (clinical and non-clinical) and externally by consultants/ contractors and vendors.
• Performing clinical literature searches related to documents in development

Qualifications

• 2+  years of medical writing experience in a Pharmaceutical, Biotech, or CRO industry
• Advanced degree (MS or PhD) in a relevant scientific field
• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
• Excellent written and verbal communication skills
• Experience with regulatory submissions (CTA/IND) and knowledge of eCTD formatting is a plus
• Ability to work independently and collectively in teams
• Must have strong interpersonal skills and the ability to work cross-functionally.
• Strong computer skills (Word, Excel, PowerPoint, and Adobe Acrobat) and the use of templates

If you”re interested in this opportunity, please send a copy of your resume to apowell@daleyaa.comHelp immediately