CrawlJobs Logo

Technical Writer - SOPs (Pharmaceutical)

bytecubit.com Logo

Bytecubit Technologies

Location Icon

Location:
United States , Concord, NC

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

50.00 - 65.00 USD / Hour

Job Description:

Generate SOPs, and associated documents, policies, and programs using client templates, format documents to include links, references to other documents and systems, embedded pictures, videos and other media to facilitate instruction as well as standardizing the templates and formatting all functions at the site. Coordinate cross-functional reviews of the documentation with the technical team and facilitate the addition of comments and updates, compile adjustments from review and route document for final review and approval. Quality Technical Writing - SOP development is key.

Job Responsibility:

  • Generate SOPs, and associated documents, policies, and programs using client templates, format documents to include links, references to other documents and systems, embedded pictures, videos and other media to facilitate instruction as well as standardizing the templates and formatting all functions at the site
  • Coordinate cross-functional reviews of the documentation with the technical team and facilitate the addition of comments and updates, compile adjustments from review and route document for final review and approval
  • Quality Technical Writing - SOP development is key

Requirements:

  • Copyediting
  • Formatting in Microsoft Word / expert level Microsoft word
  • Technical Writing
  • Customer service
  • Marketing / sales writing experience

Additional Information:

Job Posted:
December 06, 2025

Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Technical Writer - SOPs (Pharmaceutical)

Validation Technical Writer

The Validation Technical Writer supports validation, quality, and operations tea...
Location
Location
United States , Wichita
Salary
Salary:
Not provided
fagron.com Logo
Fagron
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a scientific, engineering, or technical discipline (or equivalent experience)
  • 2+ years of experience in pharmaceutical, biotech, or 503B sterile compounding environments
  • Strong understanding of validation principles, cGMP, and FDA guidance
  • Excellent technical writing, editing, and organizational skills
  • Ability to work independently and manage multiple documents in a fast-paced, regulated environment
Job Responsibility
Job Responsibility
  • Develop, revise, and format validation documents, including protocols (IQ/OQ/PQ), reports, SOPs, master plans, and change controls
  • Translate technical information from SMEs, engineers, and quality staff into accurate, user-friendly documents
  • Ensure documentation aligns with 503B regulatory requirements, cGMP, and internal quality systems
  • Maintain document consistency, traceability, and data integrity across validation lifecycle documents
  • Support audit readiness and respond to documentation-related inquiries during inspections
  • Collaborate with cross-functional teams to ensure timely completion and approval of validation documents
  • Track document progress and manage version control within electronic quality systems (eQMS)
What we offer
What we offer
  • competitive salary
  • comprehensive benefits
  • performance package
  • ability to be part of an international leader in an expanding industry
  • Fulltime
Read More
Arrow Right

Senior Medical Writer - FSP

As a Medical Writer at Parexel, your strong scientific knowledge, writing skills...
Location
Location
United States
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
  • Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP
  • Extensive clinical/scientific writing skills
  • Scientific background essential
  • writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar
  • Advanced word processing skills, including MS Office (expertise in Word)
  • software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel)
  • Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation
  • Excellent interpersonal, verbal, and written communication skills
  • Ability to consistently produce documents of high quality
Job Responsibility
Job Responsibility
  • Author Clinical Documents: Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy
  • Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input
  • Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable
  • Perform literature searches/reviews as necessary to obtain background information and training for development of documents
  • Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing
  • Quality Control: Ensure that all work is complete and of high quality prior to team distribution or shipment to client
  • Confirm data consistency and integrity across the document
  • Prepare documents for publishing readiness, when applicable
  • Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable
  • Provide suggested alternative content when contributors provide content that does not meet document needs
What we offer
What we offer
  • Foster a culture of inclusivity, collaboration, and support
  • Continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team
  • Development and promotion based on global standards and your personal development plan
  • Supportive and inclusive environment
  • Career growth and development
  • Mentorship
  • Flexible work
  • Diverse projects
  • Culture of excellence
  • Global exposure
Read More
Arrow Right

Director, Medical Writing Lead

The Director, Medical Writing is accountable for medical writing deliverables of...
Location
Location
Italy , Milano
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Undergraduate degree and at least 13 years of relevant experience in medical writing, the pharmaceutical industry, and/or clinical research
  • Advanced scientific degree and at least 10 years of relevant experience
  • Deep expertise in global regulatory submissions, including IND/CTA and NDA/MAA preparation, document strategy, and lifecycle management
  • Proven experience leading document strategies and submission activities across one or more development programs
  • Experience across diverse organizational settings (pharma, biotech, and CRO) is preferred
  • Advanced knowledge of global regulatory standards
  • Strong leadership and people management capabilities
  • Ability to manage multiple complex projects under tight timelines
  • Exceptional communication and influencing skills
  • Demonstrated expertise in outsourcing and resource management
Job Responsibility
Job Responsibility
  • Lead team of medical writers on best practices in medical writing and regulatory submission processes
  • Contribute to design of new operating model for medical writing
  • Work closely with the reg digital team to explore and assess new technologies such as generative AI and automation
  • Accountable for the successful planning and implementation of all clinical and regulatory written components of global regulatory submissions across one or more development programs
  • Provide overall oversight, review, and approve study-level documentation required for clinical trials, submission documents and other reports intended for regulatory interactions
  • Execute cross-functional process improvement initiatives on document standards, template development, and document processes
  • Facilitate systems and best-practices for training multidisciplinary colleagues participating in document authorship
  • Provide oversight for the quality and compliance of written components to company standards as well as regulatory requirements through oversight of the clinical quality control function
  • Collaborate with clinical and regulatory teams to establish optimal interfaces to enable efficient and thorough authorship/revision of key technical documents and oversight of diverse regulatory submission documents to support regulatory filings
  • Partner with other cross-functional leadership to ensure rapid identification of risks, issues, and development of potential solutions to maintain filing timelines and quality
What we offer
What we offer
  • Be part of a growing, innovation-driven company entering new therapeutic areas
  • Work on global, high-impact projects shaping access to cutting-edge specialty medicines
  • Collaborate with a diverse team of scientific and commercial experts
  • Enjoy a high level of autonomy and strategic influence within a global organization
  • Opportunities for career growth, international exposure, and leadership development
Read More
Arrow Right
New

Dental Nurse

Join Our Team at New Lodge Dental Practice – Oxted, Surrey. Are you an experienc...
Location
Location
United Kingdom , Oxted
Salary
Salary:
Not provided
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • GDC-registered Dental Nurse (or a trainee enrolled on a course with solid chairside experience)
  • Friendly, approachable, and a real team player
  • Comfortable in a busy practice and eager to learn
  • Keen to expand your knowledge in more complex treatments
Job Responsibility
Job Responsibility
  • Work alongside an experienced dentist as well as an implantologist and oral surgeon
  • Support your training in implantology and oral surgery if needed
What we offer
What we offer
  • Competitive Pay
  • Birthday Off (Paid!)
  • Free Parking
  • Modern, Bright Practice
  • Supportive Team
  • Specialist Experience
  • Referral Bonus
  • Uniform Provided
  • Discretionary Dental Care
  • Team socials and activities
  • Parttime
Read More
Arrow Right
New

Advanced Pharmacy Technician, Back End

We’re building a world of health around every individual — shaping a more connec...
Location
Location
United States , Spartanburg
Salary
Salary:
17.00 - 28.46 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
June 28, 2026
Flip Icon
Requirements
Requirements
  • Certification/licensed/registered pharmacy technician or as required by state law
  • One (1) or more years of experience as a pharmacy technician or equivalent experience
Job Responsibility
Job Responsibility
  • Partnering with function supervisor to coordinate workflow for assigned areas that prepare and process medications
  • Rotating and working in various assigned pharmacy workstations including Packaging, Staging, Returns, Receiving, Narcotics, IV, Ekit, Compounding, Omnicell Cycle Fill, Machine Packaging
  • Receiving product deliveries, pull and stage product for distribution, rotate stock, and coordinate activities with drivers to ensure shipments are accurate and deliveries are timely
  • Performing physical inventories of medication
What we offer
What we offer
  • Affordable medical plan options
  • 401(k) plan (including matching company contributions)
  • Employee stock purchase plan
  • No-cost programs for all colleagues including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching
  • Benefit solutions including paid time off, flexible work schedules, family leave, dependent care resources, colleague assistance programs, tuition assistance, retiree medical access
  • Fulltime
Read More
Arrow Right
New

Java Developer For Trading (Securities Lending) - Vice President

The Equity Finance Technology team are seeking a highly motivated software engin...
Location
Location
India , Pune
Salary
Salary:
Not provided
https://www.citi.com/ Logo
Citi
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 6-10 years of relevant experience in Apps Development or systems analysis role
  • Extensive experience system analysis and in programming of software applications
  • Experience in managing and implementing successful projects
  • Subject Matter Expert (SME) in at least one area of Applications Development
  • Ability to adjust priorities quickly as circumstances dictate
  • Extensive development experience
  • Technical skills in Java, Kafka, SQL, Git
  • Experience in performing QA, TDD and BDD practices
  • Proven ability to work in high pressure environment
  • Flexibility to work with a global team, across geographies and time zones
Job Responsibility
Job Responsibility
  • Resolve variety of high impact problems/projects through in-depth evaluation of complex business processes, system processes, and industry standards
  • Provide expertise in area and advanced knowledge of applications programming and ensure application design adheres to the overall architecture blueprint
  • Utilise advanced knowledge of system flow and develop standards for coding, testing, debugging, and implementation
  • Develop comprehensive knowledge of how areas of business, such as architecture and infrastructure, integrate to accomplish business goals
  • Provide in-depth analysis with interpretive thinking to define issues and develop innovative solutions
  • Serve as adviser or coach to mid-level developers and analysts, allocating work as necessary
  • Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgement regarding personal behaviour, conduct and business practices, and escalating, managing and reporting control issues with transparency
  • Fulltime
Read More
Arrow Right
New

Manufacturing Technician II, Instruments

The Manufacturing Technician II, Instruments will be responsible for the assembl...
Location
Location
United States , Austin
Salary
Salary:
Not provided
int.diasorin.com Logo
Diasorin
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate's Degree Associate’s degree in mechanical or electronics field required
  • Two years experience working in manufacturing environment specific to troubleshooting and problem resolution practices. required
  • Experience in Soldering. preferred
  • Experience working w/ GMP preferred.
Job Responsibility
Job Responsibility
  • Stages material for production as needed
  • Coordinate with other technicians daily in support of integration testing, manual instruction development and production process development
  • Hands-on assembly, test and troubleshooting of system builds and re-work
  • Will be responsible for becoming proficient at building subassemblies currently produced in manufacturing
  • Work from documented procedures and maintain quality data
  • Deliver manufacturing requirements and attainment of production schedule
  • Coordinate process and manual instruction updates
  • Share knowledge and train co-workers and new employees
  • Establish an effective working partnership with other Luminex departments to promote effective communication and transfer knowledge/experience to others
  • Participate in applicable departmental and interdepartmental training
What we offer
What we offer
  • competitive salary and benefits package
  • Fulltime
Read More
Arrow Right
New

Teacher of Mathematics - Maternity Cover

West Bromwich Collegiate Academy is an oversubscribed Secondary School in the Bl...
Location
Location
United Kingdom , West Bromwich
Salary
Salary:
32916.00 - 51048.00 GBP / Year
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
May 17, 2026
Flip Icon
Requirements
Requirements
  • Have experience teaching across the key stages
  • Be a consistently good/outstanding teacher
  • Be an exceptional classroom practitioner with high expectations of both learning and behaviour
  • Able to inspire, motivate and enthuse pupils
  • Committed to raising standards for all and share the same drive to constantly learn and improve
  • Show willingness to lead initiatives and show evidence of impact
  • Demonstrate a passion to make a difference to others
  • To be proficient with the use of technology for learning and have a willingness to innovate
Job Responsibility
Job Responsibility
  • To develop, plan and deliver effective and high-quality learning experiences for all students they teach
  • Be accountable for the learning and achievement of all students they teach
  • To liaise with teaching colleagues across the Academy to support strategic development, share good practice and plan collaborative activities
What we offer
What we offer
  • Opportunities across our MAT to enhance skills and experience at both primary and secondary level
  • Excellent career development opportunities
  • Exceptional CPD provision including working with national and international experts in their field
  • A supportive working environment and team ethos
  • Friendly, enthusiastic children
  • An excellent ECT induction programme
  • A working culture that recognises and reflects the importance of good mental health and wellbeing
  • Fulltime
!
Read More
Arrow Right