Regulatory Medical Writing Operations Lead

Found in: Talent UK 2A C2 - 2 weeks ago


Leeds, United Kingdom Skills Alliance Full time

** 6 (20 hours)edical Writing Operations LeadRemote, **


Are you an experienced Medical Writing Operations Lead passionate about pioneering therapies in the biotech industry? Join our innovative client, a pioneer in developing revolutionary CAR-T cell therapies for cancer treatment


?


  • You'll have the opportunity to contribute to releasing groundbreaking therapies for critically ill patients.
  • Be inspired by the collective expertise and shared commitment to transforming cancer treatment.
  • Work in a dynamic setting that celebrates diversity, experiences, and collaborative efforts.
  • Excellent opportunities for professional growth and development alongside experienced professionals and cutting-edge projects.


As a Medical Writing Operations Lead, you will be primarily responsible for all aspects related to document quality review, including data verification, editorial oversight, adherence to company style and regulatory standards, as well as submission ready formatting for routine and non-routine clinical and non-clinical regulatory documents.


:


• Provide editorial support and guidance during authoring of regulatory documents, ensuring adherence to company style and industry standards, as well as clarity, consistency, and proper usage of language and grammar.


• Support document authors with submission ready formatting for Word and PDF regulatory documents according to company guidelines and industry standards using company tools and templates, in collaboration with Regulatory Operations.


’ :


• Quality review and editorial oversight of regulatory documents, and/or a related field in the pharmaceutical or biotechnology industry


• Working with electronic document management systems (EDMS) in a regulatory environment


• Successfully interacting with cross functional team members


If you're interested and would like to find out more, reach out on LinkedIn or send your CV to lewis.ray@skillsalliance.com


  • Senior Director, Medical Writing

    Found in: Talent UK 2A C2 - 2 weeks ago


    Leeds, United Kingdom Grace Fredricks Recruitment Full time

    Role: Senior Director, Regulatory Medical Writing Location: EuropeTravel: HomebasedPosition Summary:Leads in a team environment and matrix.Contributes to and champions internal standards, regulatory, and publishing guidelines.Contributes to and champions the improvement of internal systems, tools, and processes.Able to prepare complex documents within and...


  • Leeds, United Kingdom Michael Page (UK) Full time

    The National Infrastructure Commission was established in 2016 to provide government with impartial, expert advice on major long-term infrastructure challenges. The Commission advises government on all sectors of economic infrastructure (energy, transport, water and wastewater, waste, flood risk management and digital communications), as well as on...

  • Senior Regulatory Affairs Associate

    Found in: Talent UK 2A C2 - 6 days ago


    Leeds, United Kingdom Meet Full time

    Job Title: Senior Regulatory Affairs AssociateLocation: Fully remoteCompany Description:We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team.Position Overview:As a Senior...

  • Medical Reporter/ Journalist

    Found in: Talent UK 2A C2 - 2 weeks ago


    Leeds, United Kingdom SMCpeople Full time

    To be considered for the position, having relevant sector experience is mandatory. You, the candidate need to be an experienced medical journalist or news reporter who specialises in writing clinical/medical news and able to write and report on breaking news and features for specialist doctor audiences. An experienced journalist with a keen interest in...


  • Leeds, United Kingdom Proclinical Group Full time

    Senior Regulatory Consultant - Remote - Contract Proclinical is actively seeking a Senior Regulatory Consultant. This is a remote contract position. Primary Responsibilities: This role primarily involves providing regulatory CMC support for post-approval submissions for commercial products, with a focus on biotechnology products. The successful candidate...

  • Regulatory Engineer

    3 weeks ago


    Leeds, United Kingdom Permanent Futures Full time

    Our client, a well-established manufacturer, seeks to appoint a knowledgeable Approvals Engineer with a background in highly regulated engineering! To be successful, you will be well organised and confident to manage several concurrent projects through the entire development lifecycle, liaising with sales and engineering teams as required. It is essential...


  • Leeds, United Kingdom Proclinical Staffing Full time

    Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position. This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial filing plans. ...

  • Regulatory Affairs Manager

    Found in: Jooble UK C2 - 1 week ago


    Leeds, United Kingdom Proclinical Staffing Full time

    Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position. This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial filing plans. ...

  • Senior Director, Quality Assurance and Regulatory Affairs

    Found in: Talent UK C2 - 2 weeks ago


    Leeds, United Kingdom Brenntag Full time

    Here at Brenntag we currently have an opening for a Senior Director, Quality Assurance and Regulatory Affairs to lead the overall Quality and Regulatory agenda with compliance of quality standards as well as global regulatory and compliance strategies to enable BSP strategic goals. This role can be based anywhere in the world, but ideally within Europe....


  • Leeds, United Kingdom Medical Protection Society Full time

    Legal Assistant The Medical Protection Society (MPS) have a great opportunity for a Paralegal (Legal Assistant) to join our in-house Cases Legal Team for 12 months. In this role, you will be part of our Legal Services team that is at the forefront of protecting the careers, reputation and financial risk of healthcare professionals worldwide - our...


  • Leeds, United Kingdom MERJE Ltd Full time

    Our clients are recruiting for a Financial Crime Data Services Lead Analyst to join the Financial Crime team on a permanent basis. As a Financial Crime Data Services Lead Analyst, you will help the Financial Crime team to proactively identify threats and risks through analytics. **Responsibilities**: - You will use your skills to enhance existing risk...

  • Associate Director Regulatory Affairs CMC

    Found in: Talent UK 2A C2 - 2 weeks ago


    Leeds, United Kingdom wax. Full time

    Our client, a successful and growing Biotechnology organisation, is looking to hire a new addition to the Regulatory CMC team.This role is responsible for preparing regulatory CMC submission strategy for rare disease drugs (both biologics and small molecules) and an opportunity to design creative solutions in order to obtain approval for initial BLA/NDA as...

  • Regulatory Affairs CMC Manager

    Found in: Talent UK 2A C2 - 1 week ago


    Leeds, United Kingdom Proclinical Staffing Full time

    Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position.Primary Responsibilities:This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial filing...

  • Regulatory Affairs CMC Manager

    Found in: Appcast UK C C2 - 1 week ago


    Leeds, United Kingdom Proclinical Staffing Full time

    Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position.Primary Responsibilities:This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial filing...

  • Regulatory Affairs CMC Manager

    Found in: Appcast UK C2 - 1 week ago


    Leeds, United Kingdom Proclinical Staffing Full time

    Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position.Primary Responsibilities:This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial filing...


  • Leeds, United Kingdom Proclinical Staffing Full time

    Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position. Primary Responsibilities: This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial...

  • Regulatory Affairs CMC Manager

    Found in: Jooble UK C2 - 1 week ago


    Leeds, United Kingdom Proclinical Staffing Full time

    Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position. Primary Responsibilities: This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial...

  • Regulatory Affairs CMC Manager

    Found in: Whatjobs ES C2 - 7 days ago


    Leeds, United Kingdom Proclinical Staffing Full time

    Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position. Primary Responsibilities: This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial...

  • Regulatory Affairs CMC Manager

    Found in: Appcast Linkedin GBL C2 - 1 week ago


    Leeds, United Kingdom Proclinical Staffing Full time

    Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position.Primary Responsibilities:This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial filing...


  • Leeds, United Kingdom University of Leeds Full time

    **Senior Medical Statistician**: **Are you an experienced medical statistician and want to work for an Institute leading in clinical trials research and impacting international clinical practice? Do you want to be part of a successful, highly talented, and multi-disciplinary team? Are you an enthusiastic, driven postgraduate with a major statistical...