Technical Writer / Senior Technical Writer

Job Description

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

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):

• Bachelor’s 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 2-3 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 self-starter.

• 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):

• Bachelor’s 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 4-5 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 self-starter.

• Strong organization skills

• Meticulous and attention to details required

• Strong organization skills

Additional Information

Position is full-time, 1st shift hours available. 8 AM- 5 PM

Authorization to work in the United States without Sponsorship is required.

Additional information

· Position is Full-Time, 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.

Full-time