Overview
On Site
$72.23 - $72.23 hr
Contract - W2
Contract - Independent
Contract - 12+ mo(s)
Skills
TECHNICAL WRITER
DOCUMENT SPECIALIST
PROCEDURE DOCUMENT
PHARMA COMPANIES
PHARMACEUTICAL COMPANIES
Job Details
Payrate: $72.23 - $72.23/hr.
Summary:
We are seeking a skilled Technical Writer/Procedure Document Specialist to collaborate with colleagues, customers, and stakeholders on projects focused on process enhancement and continuous improvement within the CMR Strategic Operations, GxP Compliance & Technical Operations. This role will emphasize the development of procedural documentation in a GxP environment, ensuring compliance and operational effectiveness, while also producing training materials and job aids.
Responsibilities:
Qualifications:
Critical Skills:
Top Skills:
Pay Transparency: The typical base pay for this role across the U.S. is: $72.23 - $72.23/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying STOP to messages or by contacting .
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our
#AditiConsulting
#25-23460
Summary:
We are seeking a skilled Technical Writer/Procedure Document Specialist to collaborate with colleagues, customers, and stakeholders on projects focused on process enhancement and continuous improvement within the CMR Strategic Operations, GxP Compliance & Technical Operations. This role will emphasize the development of procedural documentation in a GxP environment, ensuring compliance and operational effectiveness, while also producing training materials and job aids.
Responsibilities:
- Lead a multidisciplinary team of subject matter experts, business process owners, and key stakeholders in the development, revision, enhancement, implementation, and maintenance of process and procedural documentation.
- Plan and manage multiple process development projects simultaneously, ensuring timely delivery of targeted outcomes.
- Create and write content for training programs, including user-friendly training materials and job aids that support process understanding and application.
- Utilize your knowledge of global regulations within a GxP environment to create processes and related documentation that adhere to regulatory requirements, support corporate compliance, and are inspection-ready.
- Contribute to compliance and audit/inspection readiness strategies and plans, ensuring all documentation meets necessary standards.
- Evaluate global procedural documentation against evolving industry and regulatory requirements, audit/inspection findings, and corporate policies; recommend changes as necessary based on feedback, trends, and best practices.
Qualifications:
- Education: Minimum of a BA or BS required; an advanced degree in a relevant field is desirable. Degree or professional certification in process design or change management is a plus.
- Minimum 7+ years of experience in the design and documentation of pharmaceutical business processes and change management required.
- Experience in process training development, delivery, and/or implementation is preferred, including the creation of training content and job aids.
- GxP environment experience required; pharmacovigilance (PV) experience preferred.
- Project Management Skills: Proven ability to manage multiple projects simultaneously; PMP certification is an advantage.
- Technical Writing: Background in pharmaceutical technical writing and development of Standard Operating Procedures (SOPs) is essential.
- Organizational Skills: Strong organizational abilities, planning, and multitasking skills; capable of prioritizing multiple projects while meeting tight deadlines.
- Adaptability:Ability to work effectively under pressure and adapt to changing situations with attention to detail.
- Technical Proficiency: Proficient in common desktop tools, including MS Word, MS Excel, MS Project, and Visio and PowerPoint. Sharepoint and MS Teams and Forms a plus.
- Communication Skills: Strong verbal and written communication skills with an in-depth understanding of pharmaceutical business processes, regulations, guidelines, and industry standards relating to compliance.
Critical Skills:
- Experience in a GxP environment; PV experience preferred
- Strong project management skills with a proven ability to manage multiple projects simultaneously; PMP certification a plus
- Background in pharmaceutical technical writing, specifically Standard Operating Procedures (SOPs)
- Ability to create training materials and job aids that facilitate process understanding and implementation
- Proficiency in using Visio for process mapping and diagram creation
- Ability to work on critical initiatives under pressure while maintaining a keen attention to detail
Top Skills:
- Pharma Industry Experience
- Experience w/GxP documentation required (not GMP)
- SOP Writing expertise
- Patient Safety knowledge/experience (HUGE PLUS)
Pay Transparency: The typical base pay for this role across the U.S. is: $72.23 - $72.23/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying STOP to messages or by contacting .
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our
#AditiConsulting
#25-23460
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.