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

Secretary to the board and office assistant

We are currently recruiting for a Secretary to the Board / Office Assistant posi...

Location

Portugal , Lisboa

Salary:

Not provided

Randstad

Expiration Date

March 15, 2026

Requirements

High level of discretion, integrity, and confidentiality
Strong organizational and time-management skills, with the ability to manage multiple priorities
Excellent communication and interpersonal skills
Proficiency in English (spoken and written) will be considered a key selection criterion

Job Responsibility

Coordinating Board meetings
Managing correspondence and documentation
Supporting senior management
Assisting with general office administration
Ensuring efficient coordination of Board-related activities
Ensuring smooth day-to-day operation of the office

!

New

Quality and Compliance Manager - Aged Care

This is a pivotal leadership role for a Registered Nurse with a passion for clin...

Location

Australia , Tewantin

Salary:

121000.00 - 134000.00 AUD / Year

Randstad

Expiration Date

March 15, 2026

Requirements

Registered Nurse (AHPRA) with residential aged care experience
Direct experience in Quality/Compliance roles (or a high-performing CM/Acting Quality Manager looking to step up)
Level-headed, capable of working independently, and possess resilience
Experience in managing compliance frameworks and SIRS/feedback systems

Job Responsibility

Manage the organizational quality and risk framework to ensure 100% compliance
Conduct comprehensive audits across the entire organization to drive high care standards
Oversee consumer feedback and continuous improvement systems
Provide detailed clinical and compliance reporting to the Board
Work closely with the CEO during a period of structural evolution as the organization expands into retirement living

What we offer

6 weeks of Annual Leave + Study Leave
NFP Salary Packaging
Natural Disaster Leave
Infectious Disease Leave
Access to a structured Leadership Development Program
On-site unit available and potential relocation allowance for the right candidate

!

New

Clinical Care Partner

Our partner, a well-established Mackay facility, is looking for a dedicated Clin...

Location

Australia , Mackay

Salary:

120000.00 - 130000.00 AUD / Year

Randstad

Expiration Date

March 19, 2026

Requirements

Registered Nurse (Current AHPRA registration)
Knowledge of Aged Care Quality Standards and relevant legislation
Demonstrated experience in clinical assessment and care planning
Current QLD Driver’s Licence

Job Responsibility

Provide clinical leadership for Home & Community Care function
Be the clinical backbone of the community care team
Provide oversight to care staff delivering services in clients' homes
Conduct comprehensive clinical assessments to ensure best practice
Provide clinical advice, mentoring, and coaching to community staff
Oversee wound care, medication management, and chronic disease management
Contribute to audits, accreditation activities, and continuous improvement initiatives

Fulltime

New

Senior Accountant

Join a stable, essential-services provider in a key accounting position. We are ...

Location

Australia , Mount Barker

Salary:

90000.00 - 115000.00 AUD / Year

Randstad

Expiration Date

March 28, 2026

Requirements

Degree in Accounting/Commerce and a completed CA/CPA (or currently undertaking)
At least 2 years of experience in a hands-on corporate accounting role
Previous experience in transport, logistics, or bus services is highly desirable
Advanced MS Excel proficiency
experience with Great Plains (GP) or Microsoft Dynamics would be beneficial
A can do attitude, high attention to detail, and the ability to work autonomously

Job Responsibility

Lead End of Month processes, journal preparation, and comprehensive reporting
Manage balance sheet reconciliations, cash flow forecasts, and provide deep financial analysis to support business decisions
Oversee tax obligations including BAS and payroll tax, ensuring adherence to Australian accounting standards
Provide oversight for Accounts Payable, Accounts Receivable, and Payroll functions
Contribute to cost modelling, tender processes, and the implementation of new financial systems

What we offer

Super
Flexibility for school pick-ups/drop-offs for the right candidate

New

Payroll Officer

Our client is seeking a dedicated and detail-oriented Payroll Officer to join ou...

Location

Australia , Hindmarsh

Salary:

80000.00 - 90000.00 AUD / Year

Randstad

Expiration Date

March 22, 2026

Requirements

2 + years in a payroll and accounts role
High level of competence in the Microsoft Office Suite
Exceptional written and verbal communication skills
The ability to work under pressure, meet strict bank cut-off times, and prioritize your workload effectively
A commitment to accuracy in data entry and statutory reporting

Job Responsibility

End-to-End Payroll: Oversee and process weekly payroll, maintain employee entitlement records, and manage superannuation
Compliance: Interpret industrial awards and registered agreements to ensure all payments meet statutory requirements
Financial Support: Manage staff purchases, reconcile credit cards, process petty cash, and assist with accounts payable tasks
Contract Administration: Prepare employment contracts and maintain both paper and electronic employee records
Corporate Billing: Raise monthly invoices for corporate wage recovery and rental property costs

New

Senior Financial Accountant

We are managing a confidential search for a Senior Financial Accountant to join ...

Location

Australia , Adelaide

Salary:

120000.00 - 135000.00 AUD / Year

Randstad

Expiration Date

March 27, 2026

Requirements

Minimum of 3+ years in dedicated financial accounting, corporate audit coordination, and compliance
Strong working knowledge of AASB/IFRS and proven experience in general ledger ownership and control environments
Collaborate with operations, corporate / shared services and finance leaders in APAC region

Job Responsibility

Lead the month end closing process, including the preparation and review of complex journal entries
Manage key compliance activities, including the preparation of required submissions for BAS/GST, PAYG, Payroll Tax, and supporting income tax reconciliations
Serve as a point of contact for external auditors, coordinating documentation preparation and managing queries for statutory reviews across various entities
Collaborate with the Financial Planning & Analysis Manager and regional finance leadership to ensure alignment on monthly performance and balance sheet reviews
Identify and contribute to the implementation of process and workflow efficiencies within the current systems environment

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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