Lead Medical Writer

19 hours ago

United Kingdom Meet Full time

Position: Lead Medical Writer (Regulatory Focus)

Location: Remote (UK, Germany, or France)

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 responses to regulatory authorities. The role requires strong critical thinking skills, expertise in scientific writing, data interpretation, and a solid understanding of the regulatory content life-cycle. You will also oversee and coordinate external medical writers, ensuring all documents meet company standards, organizational objectives, and are clear, consistent, and grammatically correct.

Key Responsibilities:

  • Prepare regulatory documents for NDA/MAA/IND submissions and briefing packages, adhering to regulatory guidelines and project timelines.
  • Lead the creation of complex documents, such as Module 2 clinical documents, including Integrated Summaries of Safety (ISS) and Efficacy (ISE), with support from other medical writers.
  • Develop content and timelines for document production and manage the review and approval process, ensuring alignment with broader project schedules.
  • Review documents for clarity, scientific accuracy, consistency of content and messaging, and resolve issues with cross-functional contributors.
  • Collaborate with external publishing teams to ensure accurate and timely publication of documents.
  • Serve as a key participant in functional and cross-functional teams, providing strategic input.
  • Contribute to continuous improvement initiatives and best practices within the medical writing and regulatory teams.
  • Stay current on key regulatory, scientific, and therapeutic topics relevant to drug development.

Qualifications:

  • Bachelor's degree required; advanced degree in life sciences or a related field preferred.
  • Strong knowledge or experience in anti-infective or antiviral therapies is advantageous.
  • Proven experience writing regulatory documents, including clinical study reports, protocols, NDA/MAA submission documents, investigator brochures, and regulatory briefing materials.
  • Demonstrated ability to produce high-quality scientific writing in English.
  • Excellent project management skills with the ability to meet multiple deadlines.
  • Strong interpersonal, verbal, and written communication skills, with the ability to collaborate effectively with cross-functional and geographically diverse teams.
  • Analytical and problem-solving skills, with the ability to think clearly and adapt to changing conditions.

Why Join Us?

  • A unique culture focused on scientific excellence and collaboration, with a commitment to improving patients' lives.
  • Opportunities for professional growth and development, with strong support for individual learning and career advancement.
  • Flexible working arrangements that support work-life balance.
  • Competitive compensation and a comprehensive benefits package.

  • Lead Medical Writer

    3 weeks ago

    United Kingdom Meet Full time

    Position: Lead Medical Writer (Regulatory Focus)Location: Remote (UK, Germany, or France)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...

  • Senior Medical Writer

    1 month ago

    United Kingdom Medical Talent Full time

    Is it time for a change? This Senior Medical Writer role working as part of a thriving HIV medical affairs team could be your perfect next step.Roles at this incredible agency don't come up often so this is a rare opportunity to join a forward-thinking, truly independent healthcare communications agency at SMW level.£47k-£55k plus bonus, market leading...

  • Lead Medical Writer

    19 hours ago

    United Kingdom Meet Full time

    Position: Lead Medical Writer (Regulatory Focus) Location: Remote (UK, Germany, or France) 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...

  • Senior Medical Writer

    2 weeks ago

    United Kingdom Medical Talent Full time

    Is it time for a change? This Senior Medical Writer role working as part of a thriving omni-channel medical affairs team could be your perfect next step.Roles at this incredible agency don't come up often so this is a rare opportunity to join a forward-thinking, truly independent healthcare communications agency at SMW level.£47k-£55k plus bonus, and...

  • Lead Medical Writer

    7 days ago

    United Kingdom Meet Full time

    Position: Lead Medical Writer (Regulatory Focus)Location: Remote (UK, Germany, or France)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...

  • Principal Medical Writer

    19 hours ago

    United Kingdom Medical Talent Full time €65,000 - €70,000

    This is a Principal Medical Writer role heading up a thriving publications account. Applicants must already have significant experience working at PMW level in a MedComms agency setting. Roles at this incredible agency don't come up often so this is a rare opportunity to join this forward-thinking, truly independent healthcare communications agency at...

  • Principal Medical Writer

    4 weeks ago

    United Kingdom Medical Talent Full time

    This is a Principal Medical Writer role heading up a thriving publications account. Applicants must already have significant experience working at PMW level in a MedComms agency setting.Roles at this incredible agency don't come up often so this is a rare opportunity to join this forward-thinking, truly independent healthcare communications agency at Senior...

  • Principal Medical Writer

    7 days ago

    United Kingdom Medical Talent Full time

    This is a Principal Medical Writer role heading up a thriving publications account. Applicants must already have significant experience working at PMW level in a MedComms agency setting.Roles at this incredible agency don't come up often so this is a rare opportunity to join this forward-thinking, truly independent healthcare communications agency at Senior...

  • Senior Medical Writer

    4 hours ago

    United Kingdom X4 Life Sciences Full time

    Senior Medical Writer – Medcomms We are currently recruiting for an experienced Senior Medical Writer to join an innovative and rapidly growing medical communications agency. This agency is dedicated to translating complex scientific and medical information into clear, engaging, and impactful content that drives the future of healthcare. With a focus on...

  • Senior Medical Writer

    54 minutes ago

    United Kingdom X4 Life Sciences Full time

    Senior Medical Writer – Medcomms We are currently recruiting for an experienced Senior Medical Writer to join an innovative and rapidly growing medical communications agency. This agency is dedicated to translating complex scientific and medical information into clear, engaging, and impactful content that drives the future of healthcare. With a focus...

  • Principal Medical Writer

    5 days ago

    united kingdom RiSE Scientific Full time

    PRINCIPAL MEDICAL WRITER Company info RiSE Scientific is a global independent medical education and communications agency, founded in 2022. Our mission is to raise the quality of healthcare provision by empowering scientific organisations to create impactful education through partnership with our flexible, trained and trusted team. We believe in creating...

  • Senior Medical Writer

    5 days ago

    united kingdom RiSE Scientific Full time

    SENIOR MEDICAL WRITER Company info RiSE Scientific is a global independent medical education and communications agency, founded in 2022. Our mission is to raise the quality of healthcare provision by empowering scientific organisations to create impactful education through partnership with our flexible, trained and trusted team. We believe in creating...

  • Medical Writer

    5 days ago

    united kingdom RiSE Scientific Full time

    MEDICAL WRITER Company info RiSE Scientific is a global independent medical education and communications agency, founded in 2022. Our mission is to raise the quality of healthcare provision by empowering scientific organisations to create impactful education through partnership with our flexible, trained and trusted team. We believe in creating...

  • Freelance Medical Writer

    3 weeks ago

    United Kingdom Meet Full time

    A global independent medical communications agency is looking for a Freelance Senior Medical Writer to join their medical education team. An initial end-of-year contract, working outside of IR35, and paying competitively.The roleAs a Freelance Medical Writer you are valued for your scientific input. You will be involved in a wide range of medical...

  • Freelance Medical Writer

    2 weeks ago

    United Kingdom Meet Full time

    A global independent medical communications agency is looking for a Freelance Senior Medical Writer to join their medical education team. An initial end-of-year contract, working outside of IR35, and paying competitively.The role:As a Freelance Medical Writer you are valued for your scientific input. You will be involved in a wide range of medical...

  • Freelance Medical Writer

    19 hours ago

    United Kingdom Meet Full time

    A global independent medical communications agency is looking for a Freelance Senior Medical Writer to join their medical education team. An initial end-of-year contract, working outside of IR35, and paying competitively. The role: As a Freelance Medical Writer you are valued for your scientific input. You will be involved in a wide range of medical...

  • Freelance Medical Writer

    7 days ago

    United Kingdom Meet Full time

    A global independent medical communications agency is looking for a Freelance Senior Medical Writer to join their medical education team. An initial end-of-year contract, working outside of IR35, and paying competitively.The role:As a Freelance Medical Writer you are valued for your scientific input. You will be involved in a wide range of medical...

  • Senior Medical Writer

    2 weeks ago

    United Kingdom CDM Recruitment Full time

    Job Title: Senior Medical Writer Location: Kent Hybrid / In-office Employment Type: Full-time Job Overview: The Senior Medical Writer will play a key role in crafting high-quality, scientifically accurate content for various healthcare and pharmaceutical clients. This role requires an experienced writer with a deep understanding of medical and scientific...

  • Senior Medical Writer

    2 months ago

    United Kingdom Cognite Full time

    In the fast-changing world in which our clients seek to deliver life-changing medicines and technology, Cognite’s dynamic and forward-thinking team drives us in our mission of bringing science to life.As an independent agency, we develop innovative communications that convey science in the most effective and engaging way possible. Cultivating partnerships...

  • Senior Medical Writer

    2 months ago

    United Kingdom Cognite Full time

    In the fast-changing world in which our clients seek to deliver life-changing medicines and technology, Cognite’s dynamic and forward-thinking team drives us in our mission of bringing science to life . As an independent agency, we develop innovative communications that convey science in the most effective and engaging way possible. Cultivating...