Senior Manager of Medical Writing

3 semanas atrás

Porto, Portugal AL Solutions Tempo inteiro

George Higginson is currently searching for a highly experienced Senior Manager of Medical Writing for a clinical-stage Biotech, specialising in Immunology.
The Head of Medical Writing will be responsible for providing leadership and strategic direction to the medical writing function, acting as an integral part of the Clinical Development team responsible for providing medical writing support to our clinical development programs including preparation, development, review, revision and finalisation of clinical, medical and regulatory documents for submission to external stakeholders and communities.

**Main Responsibilities**:

- Directly contribute to cross-functional teams to integrate medical writing activities into overall project plans.
- Lead in the development and preparation of high-quality regulatory documents, including clinical study reports, protocols, investigator brochures, and submission documents (e.g., INDs, NDAs, urgent information requests, etc.).
- Prepare, edit and review medical, regulatory and clinical documents to support the development programmes including clinical study protocols, investigator brochures, non-clinical summaries, briefing documents, safety/efficacy summaries and clinical study reports.
- Drive and coordinate the development of cross-functional documents to ensure completion to timelines.
- Support cross functional project teams by providing medical writing consultancy on various aspects and provide advice on Medical Writing issues and help to resolve problems.
- Research and develop clinical and medical materials, ensuring that outputs are appropriately referenced and accurate in content and editorial style.
- Develop and support QC processes to ensure quality and accuracy within and between development documents.
- Assist in the development of templates for core documents that ensure the compliance and consistency
- Work with key functions to develop the in-house style to create a consistent and high quality image across the clients documents.

**Requirements**:

- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
- At least 7+ years’ experience of medical writing in the field of Clinical Development within the pharmaceutical industry or contract research organisations.
- Experience in writing for clinical trials across a range of therapeutic areas and geographies, ideally with Immunology/Dermatology experience.
- Previous experience in medical communications, editing and/or publishing would be advantageous.
- Previous people management experience, having built successful teams.
- Expert knowledge of global regulatory submission requirements and guidelines.
- Strong technical writing and editing skills across multiple document types.
- Ability to commute to our Porto, Portugal, office x2 days per week.

**How To Apply**:
George Higginson
AL Solutions

  • Senior Manager of Medical Writing

    1 semana atrás

    Porto, Porto, Portugal AL Solutions Tempo inteiro

    George Higginson is currently searching for a highly experienced Senior Manager of Medical Writing for a clinical-stage Biotech, specialising in Immunology.The Head of Medical Writing will be responsible for providing leadership and strategic direction to the medical writing function, acting as an integral part of the Clinical Development team responsible...

  • Medical Writer

    2 semanas atrás

    Porto, Portugal AL Solutions Tempo inteiro

    George Higginson is currently searching for a hugely motivated, ambitious and hungry Medical Writer for a clinical-stage Biotech, specialising in Dermatology/Rheumatology. They currently have x2 compounds in Phase 3 clinical trials. As the Medical Writer, you are an integral part of the Clinical Development team responsible for providing medical writing...

  • Clinical Medical Manager

    Há 3 dias

    Porto, Portugal Knok Tempo inteiro

    .Clinical Medical ManagerPorto Porto, Porto District, Portugal Learn about knok At knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every...

  • Clinical Medical Manager

    Há 3 dias

    Porto, Portugal Knok Tempo inteiro

    Clinical Medical Manager Porto Porto, Porto District, Portugal Learn about knokAt knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person...

  • Clinical Medical Manager

    Há 3 dias

    Porto, Portugal Knokcare Tempo inteiro

    .Learn about knok At knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person who embraces this mission. We are rapidly growing,...

  • Senior Molecular Geneticist

    1 semana atrás

    Porto, Porto, Portugal European Society of Human Genetics Tempo inteiro

    Employer CGPP-IBMC, i3S, University of Porto Location Porto, Portugal Details Download Job Description Applications are open - until January 6th - for a Senior Geneticist Molecular position at CGPP. We are looking for candidates with a PhD in human molecular genetics or a related field, or speciality in medical genetics (for medical doctors), or a nationally...

  • Clinical Medical Manager

    Há 3 dias

    Porto, Portugal Knok Tempo inteiro

    Clinical Medical ManagerPortoPorto, Porto District, Portugal Learn about knokAt knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person...

  • Senior Project Manager

    Há 3 dias

    Porto, Portugal Goodhue Senior Living Tempo inteiro

    As a  Senior Project Manager , you'll help us grow by managing projects in an agile environment in a Software Development Industry. You'll be responsible for mentoring and motivating the team members to improve processes, facilitating meetings, and decision-making processes, and eliminating team impediments. You'll report directly to the management team...

  • Clinical Medical Manager

    1 semana atrás

    Porto, Porto, Portugal Knokcare Tempo inteiro

    Learn about knok At knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person who embraces this mission. We are rapidly growing, delivering...

  • Clinical Medical Manager

    2 meses atrás

    Porto, Portugal knok Tempo inteiro

    **Learn about knok** At knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person who embraces this mission. We are rapidly growing,...

  • Clinical Medical Manager

    Há 2 dias

    Porto, Portugal knok Tempo inteiro

    **Learn about knok** At knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person who embraces this mission. We are rapidly growing,...

  • Senior Manager Of Engineering

    1 semana atrás

    Porto, Porto, Portugal Sword Health Tempo inteiro

    Senior Manager of Engineering Mobile, Move (Portugal Hybrid/Remote) What is your desired salary range? Please include the currency. ?Hybrid / Portugal Based Required Where in Portugal are you based? Porto office visits required.Are you proficient with Android &/or iOS Native development languages (Kotlin/Swift)?YesNoManagement Have you managed multiple...

  • Senior Manager Of Engineering

    1 semana atrás

    Porto, Porto, Portugal Sword Health Tempo inteiro

    Senior Manager of Engineering - Mobile, Move (Portugal - Hybrid/Remote) What is your desired salary range? Please include the currency. ? Hybrid / Portugal Based Required Where in Portugal are you based? Porto office visits required. Are you proficient with Android &/or iOS Native development languages (Kotlin/Swift)? Yes No Management Have you managed...

  • Clinical Medical Manager

    2 meses atrás

    Porto, Portugal Knokcare Tempo inteiro

    Learn about knok At knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person who embraces this mission. We are rapidly growing, delivering...

  • Clinical Medical Manager

    1 semana atrás

    Porto, Porto, Portugal Knokcare Tempo inteiro

    Learn about knok At knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person who embraces this mission. We are rapidly growing, delivering...

  • Clinical Medical Manager

    2 semanas atrás

    Porto, Portugal Knokcare Tempo inteiro

    Learn about knok At knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person who embraces this mission. We are rapidly growing, delivering...

  • Senior Software Engineer

    Há 3 dias

    Porto, Portugal Five9 Tempo inteiro

    .Senior Software Engineer - Voice Telco Porto, Porto District Senior Software Engineer - Voice TelcoPorto Porto, Porto District, Portugal Responsibilities: Be part of an agile team to develop a scalable, highly available global voice platform. Understand performance and scalability principles and apply when developing software. Collaborate with Product...

  • Clinical Medical Manager

    2 meses atrás

    Porto, Portugal knok Tempo inteiro

    Learn about knokAt knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person who embraces this mission. We are rapidly growing, delivering...

  • Clinical Medical Manager

    1 semana atrás

    Porto, Porto, Portugal knok Tempo inteiro

    Learn about knokAt knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person who embraces this mission. We are rapidly growing, delivering...

  • Clinical Medical Manager

    3 semanas atrás

    Porto, Portugal knok Tempo inteiro

    Learn about knokAt knok, we dare to lead and humanize the digital transformation of healthcare. We envision a world where everyone has timely access to quality healthcare through digital technology, creating a more equal society. We genuinely believe in it and you can recognize it in every person who embraces this mission. We are rapidly growing, delivering...