Technical Writer

6 days ago

Nationwide, United Kingdom RBW Consulting Full time

Technical Writer – Analytical CMC

Are you a detail-oriented technical writer with a passion for regulatory science and analytical development? Join a dynamic Regulatory Department as a Senior CMC Regulatory Technical Writer. In this pivotal role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets. This is a freelance position until March 2025 - although it is likely to be renewed.

Key Responsibilities:

* Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.

* Write CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.

* Collaborate with CMC teams (formulation, process development, analytical, and manufacturing) to gather necessary information.

* Develop and maintain CMC regulatory dossier templates, ensuring compliance with evolving guidelines.

* Manage CMC regulatory submission workflows within the document management system.

* Ensure accuracy, consistency, and completeness of data and narratives in regulatory documents.

* Oversee timelines and deliverables for multiple projects, communicating potential delays promptly.

* Provide guidance and training to team members as needed.

Qualifications:

* Degree in Pharmacy, Chemistry, Biology, or a related field.

* Previous experience as a scientist in analytical development CMC.

* At least 5 years of technical writing experience in CMC regulatory submissions.

* In-depth knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.

* Exceptional technical writing skills with the ability to clearly communicate complex scientific information.

* Meticulous attention to detail and accuracy.

* Strong organizational and project management skills to handle multiple tasks simultaneously.

* Proficiency in MS Office applications and regulatory information management software (e.g., eCTD, Veeva).

* Business level proficiency in written and spoken English.

Location:

* Fully remote role with occasional travel to the R&D Centre in Paris, France.

This position will allow you to contribute to the development of groundbreaking therapies by ensuring the highest quality in regulatory submissions. Apply today to be part of a team that values excellence and innovation

  • Senior Bid Writer

    6 days ago

    Nationwide, United Kingdom Bid Solutions Full time

    BlockDox is an award-winning smart building start-up with patented tech looking to disrupt the market and scale globally. They now have an amazing opportunity for a talented and experienced Senior Bid Writer to join their team and make a difference in a rapidly progressing business. As Senior Bid Writer you will lead their bid and proposal efforts for public...

  • Senior Bid Writer Specialist

    2 hours ago

    Nationwide, United Kingdom Bid Solutions Full time

    Overview:Bid Solutions, a pioneering smart building start-up with patented technology, is seeking an experienced Senior Bid Writer to lead their bid and proposal efforts in the UK public sector. This is a remote, flexible position suitable for a self-sufficient individual who thrives in a distributed team environment.Responsibilities:Manage the entire bid...

  • Late-Stage Clinical Applications Writer

    6 days ago

    Nationwide, United Kingdom RBW Consulting Full time

    We are looking for a highly skilled Late-Stage Clinical Applications Writer to join our team at RBW Consulting. In this role, you will be responsible for writing CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.Key Responsibilities:Write CMC sections of regulatory...

  • CMC Regulatory Documentation Specialist

    4 days ago

    Nationwide, United Kingdom RBW Consulting Full time

    Job Description:We are seeking a highly skilled Senior Technical Writer to join our dynamic Regulatory Department as a Senior CMC Regulatory Technical Writer. This role will be instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.

  • Senior Technical Writer for Biopharmaceuticals

    7 hours ago

    Nationwide, United Kingdom RBW Consulting Full time

    Key Responsibilities:Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.Write CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.Collaborate with CMC teams (formulation, process...

  • Bid Writing Expert for Public Sector

    4 days ago

    Nationwide, United Kingdom Bid Solutions Full time

    About Us:Bid Solutions is an award-winning smart building start-up with a talented and experienced team of engineers and data scientists. We are passionate about solving the biggest problems facing smart cities and urban mobility today.The Role:We are seeking an experienced Senior Bid Writer to join our team and lead our bid and proposal efforts for public...

  • Specifications Technologist

    6 days ago

    Nationwide, United Kingdom b3 jobs Ltd Full time

    Specifications Technologist To £40,000 Remote Food Manufacturing About the Specifications Technologist role We are always on the lookout for skilled Specifications Technologists to fill regular vacancies on behalf of our valued manufacturing clients across the UK. Are you passionate about ensuring that every product is safe, compliant, and accurately...

  • Specifications Technologist

    3 weeks ago

    Nationwide, United Kingdom b3 jobs Ltd Full time

    Specifications Technologist To £40,000 Remote Food Manufacturing About the Specifications Technologist role We are always on the lookout for skilled Specifications Technologists to fill regular vacancies on behalf of our valued manufacturing clients across the UK. Are you passionate about ensuring that every product is safe, compliant, and accurately...

  • Senior Technical Writer

    3 weeks ago

    Nationwide, United Kingdom RBW Consulting Full time

    We are seeking a highly skilled Regulatory Science and Analytical Development Expert to join our dynamic Regulatory Department. In this role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.Responsibilities:Prepare...

  • CMC Regulatory Specialist

    4 days ago

    Nationwide, United Kingdom RBW Consulting Full time

    OverviewR BW Consulting seeks a skilled CMC Regulatory Specialist to join our team. This is a freelance position until March 2025, with a salary of $80,000 per year.About the RoleWe are looking for a detail-oriented technical writer with a passion for regulatory science and analytical development. As a CMC Regulatory Specialist, you will be instrumental in...