Head of Medical Writing and Regulatory Submissions Expert

3 weeks ago

London, Greater London, United Kingdom Richmond Pharmacology Full time

Job Summary:

We are seeking a highly experienced and accomplished Head of Medical Writing and Regulatory Submissions to lead and develop our medical writing and regulatory teams.

As a senior leader, you will play a pivotal part in overseeing the preparation of high-quality regulatory submissions and medical writing deliverables, ensuring clarity, accuracy, and compliance with regulatory standards.

You will serve as a key advisor to both internal teams and external sponsors, providing strategic guidance on regulatory affairs and medical writing.

This role involves managing the entire medical writing and regulatory submissions process, liaising directly with sponsors, regulatory authorities, and ethics committees.

You will be responsible for high-level Quality Control (QC) across all documents, ensuring consistency and regulatory compliance.

This role also involves mentoring and supervising less experienced team members and overseeing the continuous updating of Standard Operating Procedures (SOPs) and document templates to align with the latest regulatory guidelines.

Key Responsibilities:

  • Lead the recruitment of people into the Medical Writing department with clear career progression and succession planning.
  • Attend pipeline meetings with senior leadership to forecast and manage upcoming studies, ensuring alignment with organisational priorities and timelines.
  • Monitor timesheets and productivity of their team, supporting appropriate billing and resourcing.
  • Monitor performance and capability of the team in line with annual business objectives.
  • Drive the capability development of the Medical Writing and Regulatory Affairs department, focusing on commercialisation.
  • Ensure a good working knowledge of Medical Writing and Regulatory Affairs within the wider organisation.
  • Complete and maintain up-to-date medical writing and regulatory relevant process maps.
  • Collaborate with the commercial team to accurately cost and quote medical writing and regulatory services, contributing to financially sound project proposals.

Regulatory Affairs:

  • Maintain up-to-date knowledge of relevant regulatory frameworks and guidance.
  • Provide quarterly updates to senior management and other appropriate teams on important regulatory changes and lead efforts to implement changes.
  • Provide expert advice and consultation to sponsors on regulatory affairs, submissions, and medical writing strategies, ensuring alignment with regulatory requirements and best practices.
  • Ensure overall compliance with regulatory requirements and guidance.
  • Advise on business impacts of new regulatory requirements or guidance.
  • Provide regulatory expertise to project teams on all aspects of the clinical trials process.

Medical Writing:

  • Oversee the preparation and submission of all study documentation in accordance with regulatory requirements.
  • Ensure factual accuracy and regulatory compliance for all content development.
  • Display an advanced understanding of core scientific principles underpinning medical writing tasks.
  • Display excellent scientific writing, editing, and data comprehension skills on various project types, providing accurate and clear content.

Qualifications and Experience:

  • At least 5 years of relevant experience and a relevant postgraduate qualification.
  • Educated to degree level in a relevant scientific, medical, or life sciences subject.
  • GMC license.
  • Proven experience of submissions (Phase I-III).
  • Demonstrate successful contribution to training and progression of junior staff.
  • Experience in commercialising Medical Writing/Regulatory Affairs or working with Business Development to achieve commercialisation.
  • Experience and knowledge of key subject areas, such as cardiology, hepatology, gene therapies, or rare diseases.
  • Publication in peer-reviewed journals.

Our Team:

We are a leading Contract Research Organisation (CRO) specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors.

We strive to advance medical research and contribute to the development of life-changing therapies.

We are committed to excellence and innovation, fostering a culture of collaboration and mutual respect.

Our goal is to provide high-quality services and solutions that exceed our clients' expectations.

We believe in investing in our people and providing opportunities for growth and development.

We are dedicated to making a positive impact on people's lives and contributing to the advancement of medical research.

Join us in our mission to make a difference in the lives of others.

  • Head of Medical Writing and Regulatory Submissions

    4 weeks ago

    London, Greater London, United Kingdom https:jobs-redefined.cositemap Full time

    This is a senior leadership role that requires a strong background in medical writing and regulatory affairs. The successful candidate will oversee the preparation of high-quality regulatory submissions and medical writing deliverables, ensuring clarity, accuracy, and compliance with regulatory standards.The ideal candidate will have a deep understanding of...

  • Senior Medical Writing and Regulatory Submissions Lead

    4 weeks ago

    London, Greater London, United Kingdom Richmond Pharmacology Full time

    Job Title: Head of Medical Writing and Regulatory SubmissionsTerm: Permanent, Full-timeSalary: Competitive Salary + Benefits (Private Medical, Private Dental, Pension, 33 days Annual leave (Inclusive of bank holidays & Many more)Richmond Pharmacology is a leading Contract Research Organisation (CRO) specialising in early-phase clinical trials for...

  • Senior Medical Writing and Regulatory Submissions Leader

    4 weeks ago

    London, Greater London, United Kingdom BTA Full time

    Richmond Pharmacology is a leading Contract Research Organisation (CRO) specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors. With a commitment to excellence and innovation, we strive to advance medical research and contribute to the development of life-changing therapies.The Role:We are seeking an experienced and...

  • Senior Medical Writing Lead

    4 weeks ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Senior Medical Writing LeadCpl Healthcare is seeking a highly experienced Senior Medical Writing Lead to join our team. As a key member of our Medical Writing department, you will be responsible for leading the planning and authoring of complex clinical and regulatory documents to support medical and regulatory activities across our portfolio.Key...

  • Senior Medical Writing Director

    4 weeks ago

    London, Greater London, United Kingdom Clinical Professionals Limited Full time

    Associate Director, Medical WritingJob Type: PermanentLocation: Oxford, UK – Hybrid/RemoteRemuneration: Attractive salary and packageAn exciting opportunity for an experienced Medical Writer to join a growing biotechnology company who are at the forefront of Oncology innovation within Radiopharmaceuticals.As an Associate Director, Medical Writing, you will...

  • Lead Regulatory and Medical Writing Director

    1 week ago

    London, Greater London, United Kingdom Richmond Pharmacology Full time

    Job OverviewWe are seeking an experienced and accomplished Head of Medical Writing and Regulatory Submissions to lead and develop our medical writing and regulatory teams.

  • Associate Director of Medical Writing

    4 weeks ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Job Title: Associate Director, Medical WritingJob Type: Permanent, full-timeLocation: Oxford, UK – Hybrid/RemoteRemuneration: Attractive salary and packageCpl Healthcare is seeking an experienced Medical Writer to join our growing biotechnology company, at the forefront of Oncology innovation within Radiopharmaceuticals.Job Responsibilities:Lead the...

  • Medical Writer

    4 weeks ago

    London, Greater London, United Kingdom Publicis Denmark AS Full time

    Job Title: Medical Writer - Clinical and Regulatory ExpertJob Description:We are seeking a highly skilled Medical Writer to join our team at Publicis Denmark A/S. As a Medical Writer, you will be responsible for communicating complex scientific and medical information to various audiences, including healthcare professionals, regulatory agencies, and the...

  • Medical Writer

    4 weeks ago

    London, Greater London, United Kingdom Publicis Groupe UK Full time

    At Publicis Groupe UK, we are seeking a highly skilled Medical Writer to join our team. As a Clinical and Regulatory Expert, you will be responsible for translating complex scientific and clinical information into clear and concise documents for our clients in the healthcare and pharmaceutical industries.Clinical and Regulatory Writing:Prepare and edit...

  • Medical Writing Lead with Regulatory Expertise

    1 week ago

    London, Greater London, United Kingdom Meet Full time

    Job DescriptionA challenging role as a Medical Writing Lead is available in our organization, requiring expertise in regulatory writing and experience in managing cross-functional teams.Responsibilities:Regulatory Document Preparation: Prepare high-quality regulatory documents for NDA/MAA/IND submissions and briefing packages, adhering to regulatory...

  • Lead Medical Writer

    1 month ago

    London, Greater London, United Kingdom Meet Full time

    Lead Medical WriterMeet our team of medical writing experts who are passionate about creating high-quality, regulatory-compliant documents that help bring life-changing treatments to market.We are seeking a highly skilled Lead Medical Writer to join our team, responsible for planning, drafting, and managing the review process for documents related to...

  • Lead Medical Writer and Regulatory Specialist

    5 days ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job OverviewLifelancer, a leading talent-hiring platform in Life Sciences, Pharma, and IT, seeks an experienced Head of Medical Writing and Regulatory Submissions to join our team. As a key player in medical writing and regulatory affairs, you will drive the success of projects, foster sponsor satisfaction, and ensure Lifelancer remains at the forefront of...

  • Senior Clinical Medical Writing Manager

    4 weeks ago

    London, Greater London, United Kingdom BioMarin Pharmaceutical Inc. Full time

    BioMarin Pharmaceutical Inc. is a global biotechnology company that pursues innovative science to develop new medicines for patients with significant unmet medical need.Job SummaryThe Associate Director of Clinical Medical Writing has administrative and functional oversight responsibilities for Medical Writing staff, including authoring and editing...

  • Turkish Medical Writing Specialist

    1 day ago

    London, Greater London, United Kingdom Translate Plus Full time

    At Translate Plus, we are seeking a highly skilled Turkish Medical Writer to join our team on a 3-month fixed-term contract. As a key member of our team, you will play a crucial role in communicating complex scientific and medical information to diverse audiences.Job DescriptionClinical and Regulatory Writing:We require an experienced Medical Writer with...

  • Medical Writer

    4 weeks ago

    London, Greater London, United Kingdom Publicis Groupe UK Full time

    At Publicis Groupe UK, we are seeking a highly skilled Medical Writer to join our team for a 3-month contract. As a native Danish speaker, you will be responsible for translating complex scientific and clinical information into clear and concise documents for our clients in the pharmaceutical industry.Clinical and Regulatory Writing:Prepare and edit clinical...

  • Medical Director

    4 weeks ago

    London, Greater London, United Kingdom CTI Clinical Trial and Consulting Services Full time

    Job SummaryWe are seeking a highly skilled Medical Director to join our team at CTI Clinical Trial and Consulting Services. As a Medical Director, you will be responsible for providing medical expertise and consultation to project teams, engaging with global and diverse teams and sponsors from biotech and pharma industries, and representing Worldwide Medical...

  • Senior Medical Writing Manager

    1 month ago

    London, Greater London, United Kingdom https:jobs-redefined.cositemap Full time

    Job Title: Associate Director of Clinical Medical WritingAt BioMarin, we are committed to advancing human health through bold science. As an Associate Director of Clinical Medical Writing, you will play a critical role in shaping the future of medical writing in our organization.Key Responsibilities:Provide administrative and functional oversight to Medical...

  • Regulatory Medical Writer Lead

    4 weeks ago

    London, Greater London, United Kingdom Meet Full time

    Job Title: Lead Medical Writer/Medical WriterJob Summary:As a Lead Medical Writer, you will be responsible for planning, drafting, and managing the review process for documents related to clinical studies and regulatory submissions. These documents may include key sections of marketing applications, protocols, clinical study reports, briefing materials, and...

  • Regulatory Writer

    4 weeks ago

    London, Greater London, United Kingdom MMS Holdings Inc Full time

    MMS Holdings Inc is a leading Contract Research Organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.Key Responsibilities:Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the...

  • Regulatory Submissions Lead

    2 weeks ago

    London, Greater London, United Kingdom Novartis Farmacéutica Full time

    We are seeking a talented individual to join our Regulatory Operations Team as a Regulatory Submissions Lead.About the RoleThis role offers hybrid working, requiring 3 days per week in our office. Ad-hoc working hours to overlap the US as required.Lead and manage multiple global regulatory submissions in eCTD and non-eCTD formats.Drive cross-functional teams...