Technical Writing Specialist

0 -1 yrs. in PV / 1-2 yrs. in clinical practice years

Preffered by Company

New York

Not Disclosed July 13, 2024

Job Description

Job Type: Full Time Education: Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in Dentistry or Bachelor degree in Veterinary Sciences (B.V.Sc.) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Technical Writing Specialist at Synectics Inc

Location: Warren, NJ, USA

Job Title: Technical Writing Specialist

Company: Synectics Inc

Location: Warren, NJ, USA

Job Match: Good Match

Benefits Offered:

Dental
Medical
Retirement
Vision

Job Description:

The Technical Writing Specialist supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers. The role contributes to the completion of milestones associated with facility, utility, and equipment qualification. It involves carrying out routine tasks, using basic analytical skills to recognize and solve common problems of limited scope.

As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

Responsibilities:

Develop written procedures for operation, cleaning, and maintenance of equipment and systems.
Author risk assessments for equipment, systems, facilities, and utilities.
Perform gap assessments for revisions to the site validation program and the corresponding impact of those changes to all applicable site-level functional areas and relevant procedures.
Create all documents in compliance with standards and policies.
Provide excellent customer service and support. Maintain a positive relationship with all team members and site customers while promoting a positive team environment.

Qualifications:

BA/BS degree, Bachelor of Science degree required.
Minimum 5 years of experience in technical writing, with 3 years in the pharmaceutical industry.
Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to create technically accurate documents for system lifecycle deliverables in alignment with the site validation program.
Process-oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures.
Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.
Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.
Preferred experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports.
Preferred experience writing protocol deviations, investigating out-of-specification results, performing corrective and preventive actions, and executing change controls.
Ability to interact effectively with cross-functional groups.
Strong ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion.
Ability to effectively manage multiple tasks and activities simultaneously.
Strong written and verbal communication skills, including solid presentation skills.
Proficient at writing well-formulated emails and reports.
Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
Ability to effectively communicate with employees, contractors, and vendors.
Strong computer skills in Microsoft Office Suite - Word, Excel, Outlook, and Teams, and the ability to learn new software as required.
Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.
401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics awards its employees a bonus of up to $500 for an approved professional certification. The bonus amount considers the cost of the test(s) for any certification relating to the current position, achieved during employment. Only one Certification Bonus per calendar year may be awarded per employee. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Equal Opportunity Employment: Synectics is an equal opportunity employer.