Technical Writer - SOPs (Pharmaceutical) Job at Bytecubit Technologies (Concord, NC)

Validation Technical Writer

The Validation Technical Writer supports validation, quality, and operations tea...

Location

United States , Wichita

Salary:

Not provided

Fagron

Expiration Date

Until further notice

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

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

competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry

Fulltime

Senior Medical Writer - FSP

As a Medical Writer at Parexel, your strong scientific knowledge, writing skills...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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

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

Director, Medical Writing Lead

The Director, Medical Writing is accountable for medical writing deliverables of...

Location

Italy , Milano

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

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

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

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

New

Store Associate

We’re building a world of health around every individual — shaping a more connec...

Location

United States , Chicago

Salary:

16.60 - 23.60 USD / Hour

CVS Health

Expiration Date

June 19, 2026

Requirements

At least 16 years of age
Remaining upright on the feet, particularly for sustained periods of time
Lifting and exerting up to 35 lbs of force occasionally, up to 10 lbs of force frequently, and a negligible amount of force regularly to move objects to and from, including overhead lifting
Visual Acuity - Having close visual acuity to perform activities such as: viewing a computer terminal, reading, visual inspection involving small parts/details

Job Responsibility

Providing differentiated customer service by anticipating customer needs, demonstrating compassion and care in all interactions, and actively identifying and resolving potential service issues
Focusing on the customer by giving a warm and friendly greeting, maintaining eye contact and offering help locating additional items, when needed
Accurately perform cashier duties - handling cash, checks and credit card transactions with precision while following company policies and procedures
Maintaining the sales floor by restocking shelves, checking in vendors, updating pricing information and completing inventory management tasks as directed by store manager
Supporting opening and closing store activities, when needed
Providing customer support to all departments, including photo and beauty, ensuring departments are fully stocked and operational while remaining current with all updated services and tools
Assisting pharmacy personnel when needed, including working regular shifts in the pharmacy as part of opportunities for growth and career development
Embracing and advocating for new CVS services and loyalty programs that support our purpose of helping people on their path to better health

What we offer

Dental
Vision
Wellness resources
Employee discounts
Access to certain voluntary benefits
Other programs

Parttime

New

Front Desk Receptionist

As a Front Desk Receptionist, you will be the first and last point of contact fo...

Location

United Kingdom , London

Salary:

37800.00 GBP / Year

Four Seasons

Expiration Date

Until further notice

Requirements

Previous Front Desk or guest facing experience in a hotel environment
Strong communication skills and confident guest interaction
Excellent attention to detail and organisational ability
Ability to multitask and remain calm under pressure
Experience using Opera PMS or similar systems is preferred
Positive attitude and genuine passion for hospitality
Flexibility to work a range of shifts including evenings, weekends, and public holidays
Right to Work in the UK

Job Responsibility

Welcome guests warmly and manage all aspects of arrival and departure
Handle check in and check out procedures accurately using Opera PMS
Respond to guest enquiries and requests promptly and professionally
Coordinate with Housekeeping, Concierge, and Food and Beverage teams to deliver a seamless guest experience
Manage billing and payments accurately and securely
Provide local knowledge and personalised recommendations
Identify opportunities to enhance the guest experience, including upselling where appropriate
Maintain high standards of presentation, professionalism, and service at all times

What we offer

£37,800 annual package inclusive of base salary and service charge
Structured 40 hour working week
Excellent training and clearly defined career development pathways
Strong internal progression opportunities across London and the global Four Seasons portfolio
Holiday entitlement increasing with service up to 33 days
Up to two paid Wellness Days per year
Company Sick Pay, increasing with service
Life insurance while on duty
Up to 20 complimentary nights at Four Seasons Hotels and Resorts worldwide, increasing with service, as well as heavily discounted rates at all properties
50% discount across UK Four Seasons food and beverage outlets from day one for up to four guests

Fulltime

New

Automation Engineer

We are looking for a Test Automation Engineer to join our Quality Engineering te...

Location

Australia , Melbourne

Salary:

Not provided

LGT Gruppe Holding AG

Expiration Date

Until further notice

Requirements

Minimum of 5 years in software quality assurance, with any further experience in the software development industry is highly regarded
Demonstrable experience in testing across financial services platforms, with a strong understanding of end-to-end testing dynamics
Automation testing (User Interface or Web) experience highly desirable
Experience with JIRA, Confluence, and extensive knowledge of test automation tools (i.e. Selenium, Playwright, Testmaster)
Exposure to CI/CD environments is advantageous
Experience with the Avaloq (or any other wealth) platform is highly regarded, along with a good understanding of wealth management processes and products
Solid experience with Agile SDLC methodologies, capable of adapting quickly to evolving project requirements
Degree in Computer Science or related fields preferred
Solid experience within the financial services industry, particularly in wealth management, is highly beneficial
Strong attention to detail with a logical and methodical approach to problem-solving

Job Responsibility

Ensure that all Avaloq and other platform release deliveries meet the quality standards expected by business users and are ready for production
Carry out end‑to‑end sprint testing
Support the Test Lead in overseeing the UAT and PVT test cycles
Write test plans and test cases
Execute test cases
Support business users
Prioritise defects
Provide status reporting to stakeholders
Develop test plans and cases for new functionalities across multiple platforms
Collaborate with business SMEs and management to define and sign off on testing approaches

Fulltime

New

Pharmacy Technician

At CVS Health, we are focused on transforming health care for our customers and ...

Location

United States , Encinitas

Salary:

18.90 - 28.90 USD / Hour

CVS Health

Expiration Date

July 07, 2026

Requirements

Must comply with any state board of pharmacy requirements or laws governing the practice of pharmacy, which includes but is not limited to, age, education, and licensure/certification
If the state board of pharmacy does not address or mandate a minimum age requirement, must be at least 16 years of age
If the state board of pharmacy does not address or mandate a minimum educational requirement, must have a high school diploma or equivalent, or be actively enrolled in high school or high school equivalency program
State-level licensure and national certification requirements vary by state

Job Responsibility

Following all company SOPs at each workstation to help our Pharmacists manage and improve patient health
Following pharmacy workflow procedures at each pharmacy workstation for safe and accurate prescription fulfillment
Contributing to positive patient experiences by showing empathy and genuine care
Completing basic inventory activities, as permitted by law
Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback
Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
Understanding and complying with all relevant federal, state, and local laws, regulations, professional standards, and ethical principles
Delivering additional patient health care services, where allowable by law and supported by required training and certification

What we offer

medical coverage
dental coverage
vision coverage
paid time off
retirement savings options
wellness programs

Fulltime

New

Guest Services Supervisor

We’re seeking an experienced and proactive Guest Services Supervisor to join our...

Location

United Kingdom , Hook, Hampshire

Salary:

Not provided

Four Seasons

Expiration Date

Until further notice

Requirements

Previous experience in a Front Office or Guest Services role, ideally within a luxury hospitality environment
Supervisory or leadership experience with the ability to motivate and develop a team
Excellent communication and interpersonal skills
Strong organisational skills and attention to detail
A passion for delivering exceptional guest experiences
Confidence in problem-solving and handling guest concerns
Flexibility to work shifts, including weekends and holidays
Knowledge of Opera or similar PMS systems is preferred
A positive, professional, and hands-on approach to leadership

Job Responsibility

Supervise and coordinate the daily activities of the Guest Services team to ensure smooth front desk operations
Lead shifts, allocating tasks and supporting team members throughout the day
Act as a key point of contact for guests, handling enquiries, requests, and concerns with professionalism and care
Deliver a seamless check-in and check-out experience, maintaining efficiency and a warm welcome at all times
Ensure all guest interactions reflect the highest standards of service and brand expectations
Support VIP arrivals, special requests, and personalised guest experiences
Liaise closely with Housekeeping, Concierge, and other departments to ensure guest needs are met
Monitor service quality and provide coaching, feedback, and development support to team members
Handle guest feedback and resolve issues promptly to ensure complete guest satisfaction
Ensure compliance with hotel policies, procedures, and health & safety standards

What we offer

Free Shuttle Bus transport from local towns/stations to the hotel (Fleet, Church Crookham and Elvetham Heath)
Employee travel programme
BUPA dental health care
Excellent training and career development opportunities
28 days holiday per annum including bank holidays (increasing based on length of service)
Group Personal Pension Plan upon completion of three months’ service
Opportunities to build a successful career with global potential
Access to Wagestream – a salary advance benefit
WeCare Employee Well Being Platform
Uniform and free meals on duty

Fulltime

Technical Writer - SOPs (Pharmaceutical)

Bytecubit Technologies

Location:
United States , Concord, NC

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 06, 2025

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