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

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

LGV Driver

Life as an LGV Driver… It doesn’t have to be built on long-haul road trips and o...

Location

United Kingdom , Calne

Salary:

32881.49 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

A Class 2 LGV/HGV lorry licence holder
Driver Certificate of Professional Competence (CPC) qualified
A lorry driver with some previous multi-drop experience, in any industry
Enjoy meeting a variety of customers, new and regular
Someone who appreciates good customer service and representing a business
Happy to be busy and out and about in all winds and weather

Job Responsibility

Focuses on waste streams from commercial premises across Wiltshire
Bin tipping
Skip collecting

What we offer

Healthcare maintenance cash plan
Access to shopping and gym discounts
Employee assistance programme providing 24/7 access to helplines and information, plus up to 6 counselling sessions per year
21 days holiday per annum increasing annually to 28
Holiday trading allowing employees to buy or sell holiday throughout the year
Salary Sacrifice cycle to work scheme
Auto enrolment pension scheme with 1 x life assurance

Fulltime

New

Bartender

The Bartender will deliver exceptional guest experiences by preparing quality be...

Location

Maldives , North Malé Atoll

Salary:

Not provided

Four Seasons

Expiration Date

Until further notice

Requirements

Has 1 - 2 years of relevant experience in 5 star hotels/resorts
Passed O-levels
Possesses excellent English, math and psychometric abilities
Possesses aptitude and upward mobility
Possesses guest PR skills and personal flair
Has undergone formal training in wine and food knowledge

Job Responsibility

Is directly responsible for the day‑to‑day key processes in his/her area of work
Assists his/her supervisor in executing daily operational requirements
Assumes training responsibilities when required
demonstrates strong standards awareness
promotes teamwork and acts as a role model
Attends all scheduled training sessions
Actively provides operational, employee, and guest (internal and external) feedback to management
Directs colleagues and takes responsibility for service quality and sequence
takes orders and serves (and where applicable, prepares) food & beverages according to hotel standards in a friendly, timely, and efficient manner
Handles service for large tables, VIP guests, and private events

What we offer

Career growth opportunities both within Maldives and worldwide at other Four Seasons properties
Competitive pay scheme along with a fair share of service charge on monthly basis
Shared furnished accommodation
All the meals in Employee Restaurant
Use of our Employee Gym & outdoor sports facilities
Free WIFI in employee lounge and living areas

Fulltime

New

Workday Data & Reporting Specialist

At Johnston Carmichael, the Workday Data & Reporting Specialist plays a pivotal ...

Location

United Kingdom , Glasgow

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Hands-on experience with Workday Report Writer (Advanced, Composite, Matrix Reports)
Experience creating and managing Workday dashboards and scorecards
Strong understanding of Workday data model and business objects
Experience with calculated fields and custom report data sources
Proactive in identifying areas for improvement and suggesting solutions
Keeps up-to-date with Workday product releases and new features
Ability to elicit and document business requirements
Expertise in Workday reporting, particularly within Financial Management and PSA
Enthusiasm to develop technical skills in areas like Prism Analytics and Workday Extend

Job Responsibility

Drive Reporting Excellence: Design, develop, and maintain Workday reports, dashboards, and analytics solutions that provide actionable insights to stakeholders across the firm
Champion Data Quality: Take ownership of data integrity within Workday, ensuring reports are accurate, timely, and aligned with business requirements
Enable Self-Service: Empower business users by creating intuitive dashboards and providing training on Workday’s reporting capabilities
Bridge Technical and Functional: Work across both technical reporting and business processes, understanding how functional requirements translate into reporting solutions
Grow Your Platform Skills: Develop expertise in Workday Extend, building custom applications and orchestrations that extend platform capabilities alongside your reporting work
Stay Ahead: Keep abreast of Workday product updates, new reporting features, and best practices, bringing fresh ideas to enhance our analytics capabilities

What we offer

Hybrid and flexible working
JC Aspire learning programme
Leadership Development Programme accredited by the University of Strathclyde Business School at Masters degree level

New

Server

The Server serves guest by providing exceptional knowledge of food & beverage me...

Location

United States of America , Fort Lauderdale, Florida

Salary:

Not provided

Four Seasons

Expiration Date

Until further notice

Requirements

At least 2 years of high-volume serving experience, preferably in a luxury hotel or resort
Excellent personal presentation and interpersonal skills
Extensive knowledge of wine, beer, and spirits
Ability to upsell
Strong time management skills: ability to multi-task, set priorities, and adjust to changing conditions
Willing to work in a fast-paced environment
Ability to operate all computer equipment necessary to perform the job
knowledge of Opera and Micros POS preferred/is a plus
Excellent communication and interpersonal skills
ability to work closely with other departments and communicate clearly and effectively with colleagues and guests

Job Responsibility

Describe the selection of food & beverage menu items to guests by offering interesting, and vivid descriptions of each item’s, origin, taste, and preparation methods
Confirm guest orders including any special needs or requests using the hotel’s point-of-sales system
check completed orders with guest’s original order
Coordinate food timings
Transport items to the guest table in a timely manner to ensure proper food quality
Anticipate guest needs, ascertain satisfaction, and offer suggestions, and respond urgently and appropriately to guest concerns and requests
Properly and accurately close guest checks
process cash and credit card payments
properly settle voided checks or complimentary items

What we offer

Competitive Salary, wages, and a comprehensive benefits package
Excellent Training and Development opportunities
Complimentary Accommodation at other Four Seasons Hotels and Resort
Complimentary Dry Cleaning for Employee Uniforms
Complimentary Employee Meals

Fulltime

New

Product Manager, Media Management

As the Product Manager for Media Management, you'll own the media processing pip...

Location

United States , San Francisco

Salary:

171000.00 - 235000.00 USD / Year

Descript

Expiration Date

Until further notice

Requirements

5 or more years of product experience creating products for users with high volumes, complex needs, and zero tolerance for downtime
Experience building enterprise products that people love
Ability to work effectively with research and engineering teams
Comfortable evaluating ML models, running experiments to measure quality improvements, and making tradeoffs between accuracy, performance, and cost
Experience in doing customer discovery and defining features that solve real problems
Attracted to ambiguous problems, know how to ask smart questions, and translate ideas into action
Care about craft and sweating the details

Job Responsibility

Create search capabilities that unlocks content reuse across projects
Own the upload, transcription, and visual understanding pipelines
Work with AI research to make sure we have the best models in the world for our media understanding and processing pipelines
Make it seamless for large teams to ingest and export high volumes of media from their systems
Balance competing priorities across customer segments

What we offer

Generous healthcare package
401k matching program
Catered lunches
Flexible vacation time

Fulltime

New

Software Engineer III

The Mission Starts Here TheIncLab engineers and delivers intelligent digital app...

Location

United States , McLean; Tampa; Nashville; Colorado Springs

Salary:

Not provided

TheIncLab

Expiration Date

Until further notice

Requirements

A bachelor's degree in engineering, Computer Science, Information Systems
5+ years of experience in software development with full-stack expertise
Proficiency in Node.js, Typescript, and .NET (C#)
Strong experience with frontend technologies such as React, Angular, or Vue.js
Experience in building cross-platform applications (web, desktop, mobile, tablet)
Solid understanding of databases, caching, and performance optimization
Experience with containerization and orchestration (Docker, Kubernetes)
Experience in communication protocols such as REST, WebSockets, and message queues (such as Kafka)
Strong grasp of version control systems (such as Git)
Deep understanding of software architecture, system design, and data modeling

Job Responsibility

Design, develop, and maintain scalable, high-performance applications using Node.js, Typescript, and C#
Work on complex software features and projects with minimal supervision
Make technical decisions and provide architectural input
Implement and optimize RESTful APIs and microservices
Work with front-end frameworks (React, Angular, or Vue) to create dynamic and responsive user interfaces
Design and implement databases and database transaction layers
Collaborate with UI/UX and product teams to understand customer desires and determine feasibility
Document development progress through tools such as Git, Jira, and Confluence
Lead code reviews and ensures high coding standards
Guide junior engineers on best practices and implementation patterns

What we offer

Hybrid and Flexible Work Environment that supports working remote and in-office
Professional Development Programs to support training and certification reimbursement, skill development, continued learning, and career advancement
Paid Time Off for personal time off, volunteering, holidays, and more
Health and Wellness Benefits that include options for Medical, Dental, and Vision insurance along with access to Wellness, Mental Health, and Employee Assistance Programs
100% Company Paid Benefits that include STD, LTD, and Basic Life insurance
401(k) Plan Options that includes up to a 4% match and immediate vesting
Incentive Bonuses for eligible clearance, performance, retention, and referrals
A company culture that values your individual strengths, career goals, and contributions to the team

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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