Principal Medical Writer
hace 15 horas
Description
Principal Medical Writer
Syneos 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 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 minimal supervision.
Develops or supports a variety of documents that include but are 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;
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 administrative 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.
Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
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 challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
#LI - PM1
#J-18808-Ljbffr
-
Principal Medical Writer
hace 15 horas
España ENGINEERINGUK A tiempo completoAs a Principal Medical Writer, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing:Acts as the medical writing expert for assigned drug projects, and leads the planning, the development and the implementation of the content strategy of clinical submission...
-
Principal Medical Writer
hace 15 horas
España ICON A tiempo completoAs a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing:Acts as the medical writing expert for assigned drug projects, and leads the planning, the development and the implementation of the content strategy of clinical submission...
-
Principal Medical Writer
hace 15 horas
España Syneos - Clinical and Corporate - Prod A tiempo completoDescription Principal Medical Writer Syneos 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...
-
Medical Writer
hace 3 semanas
España Page Personnel España A tiempo completoTus funciones serán: - Redacción y revisión de textos científicos dirigidos a profesionales de la salud (materiales promocionales y no promocionales, on y off line; slide decks; actas de reuniones; abstracts, pósters, edición artículos científicos, etc) - Soporte científico y colaboración con los diferentes departamentos de la agencia...
-
Principal Medical Writer
hace 15 horas
España Syneos Health, Inc. A tiempo completoUpdated: October 15, 2024Location: Spain-Europe - ESP-Home-Based (Barcelona)Job ID:24005388Syneos 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...
-
Principal Medical Writer
hace 15 horas
España Syneos Health A tiempo completoDescriptionPrincipal Medical WriterSyneos 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...
-
Principal Medical Writer
hace 15 horas
España Syneos Health, Inc. A tiempo completoUpdated: October 15, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID: 24005388Syneos 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...
-
Medical Writers
hace 3 semanas
España The Legends Agency A tiempo completoJob Title: Medical Writer Location: Remote Job Type: Full-time About our client: Our client is a leading UK agency specializing in medical writing and communication. We are committed to delivering high-quality, evidence-based content that enhances understanding and supports our clients in the healthcare sector. Our team of experts collaborates closely with...
-
Technical Writer
hace 4 semanas
España Page Personnel España A tiempo completoFormarás parte de importante empresa de referencia ubicada en Madrid, siendo tus responsabilidades: - Apoyar a la unidad de I+D con la creación y preparación de documentos relacionados con el producto, documentos de control y validación de desarrollo/diseño. - Colaborar con equipos multidisciplinarios para comprender diferentes aspectos del desarrollo...
-
Sr Medical Writer
hace 15 horas
España Syneos Health, Inc. A tiempo completoUpdated: October 15, 2024Location: Spain-Europe - ESP-Client-Based (Madrid)Job ID: 24005387Syneos 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...
-
Technical Writer
hace 2 semanas
España buscojobs España A tiempo completoGalicia es un foco de talento y de oportunidades para las empresas tecnológicas de este país, y es gracias a gente como Daniel y David, que en el año 2000 fundaron Corunet by Sngular. NOSOTROS LES QUEREMOS MUCHO y sobre todo, compartimos una forma de hacer con ellos: dar la prioridad número uno al equipo, consolidando un dream team capaz de conseguirlo...
-
Content Writer
hace 1 mes
España Depor village A tiempo completo¿Eres recién graduado/a en Periodismo, Comunicación o similar, además eres una persona emprendedora y te apasionan los nuevos retos? Entonces, ¡Ésta es tu carrera! En Deporvillage somos jóvenes, ambiciosos, emprendedores, dinámicos y muy trabajadores; y tenemos la suerte de contar con un equipazo profesional y experto digno de la mejor...
-
Sr Medical Writer
hace 15 horas
España Syneos Health A tiempo completoDescriptionSenior Medical WriterSyneos 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...
-
Sr Medical Writer
hace 15 horas
España Syneos Health, Inc. A tiempo completoUpdated: November 4, 2024Location: Spain-Europe - ESP-Home-Based (Barcelona)Job ID: 24004551Syneos 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...
-
España Med Communications International A tiempo completoJob Description - (Canada only) PharmD - Medical Writer / Senior Scientific Communications Specialist POSITION SUMMARY The Senior Scientific Communications Specialist is a professional with scientific, clinical, and therapeutic area expertise, responsible for oversight of staff and client services. The position also provides scientifically accurate and...
-
Sr Medical Editor
hace 3 semanas
España Syneos Health, Inc. A tiempo completoUpdated: November 11, 2024Location: Spain-Europe - ESP-Home-Based (Barcelona)Job ID:24004554Syneos 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...
-
Sr Medical Editor
hace 3 semanas
España Syneos Health, Inc. A tiempo completoUpdated: November 11, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID:24004554Syneos 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...
-
Sr Medical Editor
hace 3 semanas
España Syneos Health A tiempo completoDescriptionSenior Medical EditorSyneos 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...
-
Gestor/a Comercial
hace 3 semanas
España ERREKA A tiempo completoEn el ámbito del proceso de diversificación de ERREKA, su división de plásticos ha lanzado ERREKA MEDICAL. ERREKA MEDICAL se ha creado para convertirse en un referente dentro de un sector de alto valor añadido y con unas tasas de crecimiento elevadas. Con una propuesta de Contract-Manufacturing y en continua colaboración con nuestros clientes,...
-
Sr Regulatory Medical Writer
hace 15 horas
España Syneos Health A tiempo completoDescriptionSenior Medical WriterSyneos 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...
