Technical Writer / Senior Technical Writer
Technical Writer / Senior Technical Writer
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Salary Not Disclosed
1 Vacancy
Job Description
Technical Writer:
Manage the production of simple scientific and technical documents supporting the work performed in the Department. Contribute to revision of technical documents training material and other written material.
Senior Technical Writer:
Manage the production of complex scientific and technical documents supporting the work performed in the Department. Support the revision of Local and Global SOP guideline documents training material and other written material.
Qualifications :
Technical Writer
Essential Duties and Responsibilities:
- Applies GMP/GLP in all areas of responsibility as appropriate
- Applies the highest quality standard in all areas of responsibility
- Demonstrates and promotes the company vision
- Demonstrates strong client service skills teamwork and collaboration
- Proactively plans and multitasks to maximize productivity
- Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
- Regular attendance and punctuality
- Participate to the drafting and maintenance of templates for Department protocols/methods/reports and any other documents
- With support Interact with Group Leaders Data Reviewers and Scientists to gather the information necessary to the generation of protocols methods or reports
- Draft review and author validation protocols methods and reports with support as appropriate
- With the support of the technical GL address client comments as appropriate
- With support from Technical Group Leaders and senior technical writers interacts with appropriate parties to write Exceptions and other Quality Assurance documents pertaining to Studies performed and samples analyzed in the Department
- Participate to the initiatives put in place to increase the efficiency of all processes pertaining to document Exception or SOP writing using LEAN principles
- Contribute to technical and regulatory documents
- Demonstrates ability to work on multiple project
- Demonstrates ability to teach trainees as part of a team or in an independent setting
- Communicates effectively with client staff members
- Conducts all activities in a safe and efficient manner
- Performs other duties as assigned
Basic Minimum Qualifications (BMQ):
To perform this job successfully the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge skill or ability required. (List three to five key quantifiable skills or position requirements that the candidate must have to be considered for this position.)
Education/Experience (BMQ):
Bachelors Degree (preferably in Life Sciences and/or Engineering)
Experience in FDA/cGMP regulated Biotech/Pharmaceutical industry
Good written and verbal communication skills are required; At least 23 years in writing experience of a technical nature; previous writing experience used for cGMP/Regulatory documents.
Skilled level in process improvement tools and methodologies.
Computer skills (expertise with MS Project Excel and other Windows related applications). Diplomacy negotiation skills independent work skills strong work ethic and selfstarter.
Strong organization skills
Meticulous and attention to details required
Strong organization skills
Senior Technical Writer
Essential Duties and Responsibilities:
Applies GMP/GLP in all areas of responsibility as appropriate
Applies the highest quality standard in all areas of responsibility
Demonstrates and promotes the company vision
Demonstrates strong client service skills teamwork and collaboration
Proactively plans and multitasks to maximize productivity
Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
Regular attendance and punctuality
Draft/Maintain templates for Department protocols/methods/reports and any other documents
Interact with Group Leaders/Managers Data Reviewers and Scientists to gather the information necessary to the generation of protocols methods or reports
Draft review and author validation protocols methods and reports with support as appropriate
Author internal data assessment reports in collaboration with appropriate subject matter experts
With the support of the technical GL address client comments and interact with external clients to finalize documents as appropriate
With minimal support from Technical Group Leaders interacts with appropriate parties to write Exceptions and other Quality Assurance documents pertaining to Studies performed and samples analyzed in the Department
Act as a point of support for new and junior Technical Writers
Participate to the initiatives put in place to increase the efficiency of all processes pertaining to document Exception or SOP writing using LEAN principles
Contribute to technical and regulatory documents
Demonstrates ability to work on multiple projects
Communicates effectively with client staff members Conducts all activities in a safe and efficient manner Performs other duties as assigned
Basic Minimum Qualifications (BMQ):
To perform this job successfully the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge skill or ability required. (List three to five key quantifiable skills or position requirements that the candidate must have to be considered for this position.)
Education/Experience (BMQ):
Bachelors Degree (preferably in Life Sciences and/or Engineering)
Experience in FDA/cGMP regulated Biotech/Pharmaceutical industry
Good written and verbal communication skills are required; At least 45 years in writing experience of a technical nature; previous writing experience used for cGMP/Regulatory documents.
Skilled level in process improvement tools and methodologies.
Computer skills (expertise with MS Project Excel and other Windows related applications). Diplomacy negotiation skills independent work skills strong work ethic and selfstarter.
Strong organization skills
Meticulous and attention to details required
Strong organization skills
Additional Information :
Position is fulltime 1st shift hours available. 8 AM 5 PM
Authorization to work in the United States without Sponsorship is required.
Additional information
Position is FullTime 40 hours per week. Candidates currently living within a commutable distance of Lancaster PA are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
