Senior/principal Medical Writer

hace 3 semanas

Barcelona, España Syneos Health Clinical A tiempo completo

**Description**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**

**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

**Job responsibilities**
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.
- Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
- Develops good working relationships with internal and external colleagues.
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with mínimal supervision.
- Develops or supports a variety of documents that include but not limited to:

- Clinical study protocols and clinical protocol amendments;
- Clinical study reports;
- Patient narratives;
- Clinical development plans;
- IND submissions and annual reports;
- Integrated summary reports;
- NDA and (e)CTD submissions;
- Investigator brochures, as well as;
- Clinical journal manuscripts, clinical journal abstracts, and client presentations.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Serves as peer reviewer providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that client objectives are met and overall quality standards are maintained.
- Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates when completing medical writing projects, on-time and on-budget.
- Performs on-line clinical literature searches, as applicable.
- Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
- Understands budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
- Completes required administrated tasks within the specified timeframes.
- Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

**Qualifications**

**What we’re looking for**
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
- Extensive knowledge of English grammar with a familiarity with AMA style guide.
- Understanding of FDA and ICH regulations and guidelines strongly preferred.
- Demonstrated effective presentation, proofreading, and interpersonal, skills and ensure a team-oriented approach.
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

**Get to know Syneos Health**

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and

  • International Medical Writer

    hace 1 mes

    Barcelona, España CDM Barcelona A tiempo completo

    Overview: **INTERNATIONAL MEDICAL WRITER** **Location: Hybrid** **ABOUT THE ROLE**: In the midst of a sustained growth spurt based on excellent client partnerships and a strong business development plan, CDM Barcelona are again looking for outstanding talent to bring into the agency. Attitude is everything, so we’re looking for a creative and innovative...

  • International Medical Writer

    hace 4 semanas

    Barcelona, España Omnicom Health Group A tiempo completo

    Overview: **INTERNATIONAL MEDICAL WRITER** **Barcelona** **ABOUT THE ROLE**: In the midst of a sustained growth spurt based on excellent client partnerships and a strong business development plan, CDM Barcelona are again looking for outstanding talent to bring into the agency. Attitude is everything, so we’re looking for a creative and innovative Medical...

  • Sr. Medical Writer

    hace 2 días

    Barcelona, España Thermo Fisher Scientific A tiempo completo

    **Sr. Writer, Publications - Evidera** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals...

  • Sr. Medical Writer

    hace 2 días

    Barcelona, España Thermo Fisher Scientific A tiempo completo

    **Sr. Writer, Publications - Evidera** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals...

  • Senior Medical Writer

    hace 26 minutos

    Barcelona, España Thermo Fisher Scientific A tiempo completo

    Senior Medical Writer (EMEA) (FSP; Remote) At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual...

  • Medical Writer

    hace 3 semanas

    Barcelona, Barcelona, España Syneos Health A tiempo completo

    Medical Writer ISyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we...

  • Medical Writer

    hace 2 semanas

    Barcelona, España Morgan Philips Executive Search A tiempo completo

    Resumen del puesto:El Document Medical Writer será responsable de la recopilación y edición de documentos regulatorios y científicos, con un enfoque especial en procesos de submission y en la anonymization y redaction de datos para cumplir con las regulaciones de protección de datos. Este rol es crucial para asegurar la precisión y la conformidad...

  • Medical Writer

    hace 2 semanas

    Barcelona, Barcelona, España Morgan Philips Executive Search A tiempo completo

    Resumen del puesto:El Document Medical Writer será responsable de la recopilación y edición de documentos regulatorios y científicos, con un enfoque especial en procesos de submission y en la anonymization y redaction de datos para cumplir con las regulaciones de protección de datos. Este rol es crucial para asegurar la precisión y la conformidad...

  • Project Consultant and Medical Writer-new

    hace 1 mes

    Barcelona, España Vall d'Hebron Institut de Recerca A tiempo completo

    VHIR-RRHH-FOR-003_vs01_ TheVall d'Hebron Research Institute (VHIR) is a public sector institution that promotes and develops the research, innovation and biosanitary teaching of the Vall d’Hebron University Hospital. Through the excellence of our research, we identify problems of society and we contribute to spread them around the world. In April...

  • Medical Writer

    hace 1 mes

    Barcelona, España LHH A tiempo completo

    Desde LHH buscamos un/a redactor/a médico/a científico. Se trata de un puesto a tiempo completo y la persona seleccionada se incorporará a la Unidad de Coordinación Científica (SCU). En resumen, el/la redactor/a médico/a científico será responsable de redactar los documentos y artículos científicos pertinentes bajo la dirección de el/la...

  • Senior Medical Director

    hace 1 mes

    Barcelona, España AstraZeneca A tiempo completo

    AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies. AstraZeneca has a multifaceted environment that cultivates...

  • Medical Monitor

    hace 2 semanas

    Barcelona, Barcelona, España Michael Page A tiempo completo

    ¿Dónde vas a trabajar? A Biopharmaceutical company is looking for a Medical Monitor - Oncology ¿Qué harás en tu nuevo puesto? The Medical Monitor collaborates in the overall global (US/EU) clinical development for oncology compounds, taking into consideration both medical and scientific issues. She/he is part of a multi-disciplinary, multi-regional,...

  • Global Medical Senior Manager

    hace 1 mes

    Barcelona, España Almirall A tiempo completo

    Fecha: 25 ene. 2024- Ubicación: SC00 - HEADQUARTERS - BARCELON**Misión**: Reporting into the Global Medical Senior Director (Strategy & Execution), the Global Medical Manager for Atopic Dermatitis is accountable for providing medical and scientific strategic leadership about the assigned biologic product, ensure close alignment with the Global Brand Team...

  • Statistical Programmers

    hace 1 mes

    Barcelona, España AstraZeneca A tiempo completo

    We are currently recruiting statistical programmers at the senior level or higher (depending on your previous experience) to join our growing early-stage drug portfolio team. **About the role** At AstraZeneca we’re driving leading-edge approaches to drug development across many business areas - within Early Biometrics & Statistical Innovation (EB&SI) a...

  • Medical & Scientific Affairs Trainee

    hace 1 mes

    Barcelona, España DDB Health Barcelona A tiempo completo

    Overview: **About DDB Health Barcelona**: We are DDB Health Barcelona, a dynamic, young, global agency specialized in healthcare and wellness, breaking the rules of communication. We are part of the global DDB Health network, present in six countries. In Barcelona, we have a multidisciplinary team of scientists, creatives and strategists with a rebellious...

  • Biopharmaceuticals Medical Evidence

    hace 1 mes

    Barcelona, España AstraZeneca A tiempo completo

    **Introduction to Role**: Join our dynamic BioPharmaceuticals Medical (BPM) team, where we strive to provide healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca therapies. As the Senior Director, Health Data Implementation, you will be at the forefront of designing and delivering innovative real world data...

  • Medical Monitor

    hace 2 semanas

    Barcelona, España Michael Page A tiempo completo

    ¿Dónde vas a trabajar? A Biopharmaceutical company is looking for a Medical Monitor - Oncology ¿Qué harás en tu nuevo puesto? The Medical Monitor collaborates in the overall global (US/EU) clinical development for oncology compounds, taking into consideration both medical and scientific issues. She/he is part of a multi-disciplinary, multi-regional,...

  • Medical Monitor

    hace 1 semana

    Barcelona, España Page Personnel A tiempo completo

    The candidate must be a hematologist| It is essential that the candidate has worked as a medical monitor or similarA Biopharmaceutical company is looking for a Medical Monitor - OncologyThe Medical Monitor collaborates in the overall global (US/EU) clinical development for oncology compounds, taking into consideration both medical and scientific issues....

  • Medical & Affairs Assistant - Intern (Ddb Health

    hace 4 semanas

    Barcelona, España Omnicom Health Group A tiempo completo

    Overview: **About DDB Health Barcelona**: We are DDB Health Barcelona, a dynamic, young, global agency specialized in healthcare and wellness, breaking the rules of communication. We are part of the global DDB Health network, present in six countries. In Barcelona, we have a multidisciplinary team of scientists, creatives and strategists with a rebellious...

  • Russian Speaking Publisher Manager Based In Barcelona Or Remote

    hace 3 días

    Barcelona, España International People Solutions B.V. A tiempo completo

    Russian Speaking Publisher Manager based in Barcelona or REMOTESolicitar empleo de Russian Speaking Publisher Manager based in Barcelona or REMOTE en International People Solutions B.V.Russian Speaking Publisher Manager based in Barcelona or REMOTESolicitar empleo de Russian Speaking Publisher Manager based in Barcelona or REMOTE en International People...