56 Ofertas de Zoetis en España

Join to apply for the Sr Medical Writer (Drug Development/Late Phase Exp) role at Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers on the customer and the patient, aiming to simplify and streamline work to make Syneos Health easier to work for and with. Opportunities exist in Functional Service Provider partnerships or Full-Service environments, collaborating with teams to accelerate delivery of therapies.

• Mentor and lead less experienced medical writers on complex projects as needed.
• Act as lead for assigned writing projects and manage medical writing activities for individual studies, coordinating with data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
• Develop or support a variety of documents, including: protocols and amendments; clinical study reports; patient narratives; development plans; IND submissions and annual reports; integrated summary reports; NDA/eCTD submissions; investigator brochures; clinical journal manuscripts and abstracts; client presentations.
• Identify and propose solutions to issues arising during writing, including escalation as appropriate.
• Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
• Collaborate with department heads and staff to produce deliverables.
• Serve as peer reviewer on internal reviews, providing comments on drafts and final documents.
• Adhere to regulatory standards (ICH-E3), SOPs, client standards, and approved templates to complete projects on time and on budget.
• Perform online literature searches and stay familiar with current industry practices and regulatory guidelines affecting medical writing.
• Maintain awareness of project budgets and communicate changes to medical writing leadership; complete administrative tasks within specified timeframes.
• Travel may be required (<25%).

• Bachelor of Science (or BA in Social Sciences, English, or Communications) with relevant scientific/medical knowledge and writing experience.
• Extensive knowledge of English grammar and FDA/ICH regulations and guidelines; familiarity with AMA style guide.
• Demonstrated independence with strong presentation, proofreading, interpersonal, and leadership skills; team-oriented approach.
• Proficiency in Word, Excel, PowerPoint, email, and internet.
• Ability to interpret and present clinical data and other complex information.

Over the past 5 years, we have worked with 94% of all Novel FDA-Approved Drugs, 95% of EMA Authorized Products, and supported studies across thousands of sites and patients. We value initiative, collaboration, and a culture that embraces diversity of thought and background.

Strong medical writing skills with lead-authoring experience for various drug regulatory documents. Capacity to manage multiple deliverables in parallel while maintaining quality and timelines. Opportunity to grow within a global team.

• Mid-Senior level

• Full-time

• Marketing, Public Relations, and Writing/Editing

Additional information: Referrals may increase interview chances. No change in content beyond refining for readability and compliance with formatting rules.

Join to apply for the Sr Medical Writer (Drug Development/Late Phase Exp) role at Syneos Health

Description

Sr Medical Writer (Drug Development/Late Phase Exp)

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

• 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.

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• 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, as well as;
• Clinical journal manuscripts, clinical journal abstracts, and client presentations.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Serves as peer reviewer on internal review team providing review comments on draft and final documents.
• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, 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.
• Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Maintains awareness of 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%).

• 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 and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership 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.

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.

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.

Strong medical writing skills and experience in lead authoring various drug regulatory documents. Ability to lead and work on multiple deliverables in parallel whilst maintaining quality and meeting agreed timelines/milestones. Opportunity to work in a fantastic global team environment and ample opportunities for growth and development.

Join to apply for the Drug Development Fellow (Childhood cancer and blood disorders) role at Vall d’Hebron Institute of Research (VHIR) - Vall d'Hebron Institut de Recerca.

The Paediatric Haematology and Oncology Division of Vall d’Hebron Hospital treats around 100 children and adolescents with cancer per year as well as up to 500 new patients with haematological conditions and performs 40-50 stem cell transplantations. All research is conducted through the Childhood Cancer and Blood Disorders Group of VHIR. There are 30 phase 1/2 and 15 phase 3/4 clinical trials ongoing and several patient registries. The candidate will join a very active team (there are 30 early-phase and 18 late-phase clinical trials ongoing). This team consists of 18 paediatric haematology and oncology consultants, 3 study coordinators, 2 data managers and 1 research nurse, and the candidate will be involved in the day-to-day conduct of late-phase clinical trials and patient registries.

Required:

• Degree in Medicine
• Specialist training in Paediatrics (via MIR or equivalent)

Desired:

• Good command of English
• Training in biomedical research, good clinical practice, stem cell transplantation, palliative care, advanced life support
• Knowledge of medical English

Required:

• At least 2-years of experience in paediatric haematology and oncology

Desired:

• Experience in research in paediatric haematology, oncology and stem cell transplantation
• Good communication skills and good team player
• Experience in Clinical Trials in paediatric haematology and oncology, particularly early-phase

• Participation in recruitment and trial-related activities of patients with haematological malignancies enrolled in early/late-phase clinical trials (paediatric haematology and oncology).
• Communication with sponsors.
• Participation in the development of academic clinical trials, our personalised medicine programme and research projects led by the unit in the field of paediatric hematologic malignancies, in close collaboration with ITCC Prepare/Organize.
• The post holder will be able to conduct academic research in the field of paediatric haematology and oncology, with the possibility of conducting a doctorate/PhD degree.

• Full-time position: 40h/week
• Starting date: immediate
• Gross annual salary: Remuneration will depend on experience and skills. Salary ranges are consistent with our Collective Agreement pay scale.
• Contract: Technical and scientific activities contract linked to the project activities

• Incorporation to Vall d’Hebron Research Institute (VHIR), a public sector institution that promotes and develops biomedical research, innovation and teaching at Vall d'Hebron University Hospital (HUVH), the biggest hospital of Barcelona and the largest of Catalan Institute of Health (ICS).
• A scientific environment of excellence, highly dynamic, where high-end biomedical projects are continuously developed.
• Continuous learning and a wide range of responsibilities within a stimulating work environment.
• Individual training opportunities.
• Flexible working hours.
• 23 days of holidays + 9 personal days.
• Flexible Remuneration Program (including dining checks, health insurance, transportation and more)
• Corporate Benefits: platform through which you can obtain significant discounts on travel, culture, technology, gastronomy, sports. among many others.
• Healthy Offering: choose from a variety of wellbeing focused activities to be the healthiest you.

Deadline to apply:

VHIR embraces Equality and Diversity. As reflected in our values we work toward ensuring inclusion and equal opportunity in recruitment, hiring, training, and management for all staff within the organization, regardless of gender, civil status, family status, sexual orientation, gender identity and expression, religion, age, functional diversity or ethnicity.

• Entry level

• Full-time

• Research, Analyst, and Information Technology

• Research Services

Updated: August 25, 2025
Location: Barcelona, Spain
Job ID: -OTHLOC-3529-2DBARC-2DR

Description

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.

- Acts as lead for assigned writing projects.

- 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 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.

- Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.

- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.

- Serves as peer reviewer on internal review team providing review commentson draft and final documents.

- Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, 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.

- Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.

- Maintains awareness of 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

- 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 and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.

- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership 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.

Summary

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health (Nasdaq:SYNH) 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.

Overview

Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

Location: Madrid, Spain

Job ID: Description

Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

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 :

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.

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• 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 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; and clinical journal manuscripts, abstracts, and client presentations.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Reviews statistical analysis plans and table / figure / listing specifications for content, grammar, format, and consistency.
• Interacts with department head and staff in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
• Serves as peer reviewer on internal review team providing review comments on draft and final documents.
• Adheres to regulatory standards (ICH-E3, company SOPs, client standards, and templates) when completing medical writing projects, on time and on budget.
• Performs online literature searches, as applicable, and stays familiar with current industry practices and regulatory requirements.
• Maintains awareness of budget specifications for assigned projects, working within 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%).

• 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 and FDA and ICH regulations and guidelines, and familiarity with AMA style guide.
• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

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.

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. 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. The Company is committed to compliance with applicable laws and regulations, including the EU Equality Directive and the Americans with Disabilities Act, with reasonable accommodations where appropriate.

Strong medical writing skills and experience in lead authoring various drug regulatory documents. Ability to lead and work on multiple deliverables in parallel whilst maintaining quality and meeting agreed timelines / milestones. Opportunity to work in a fantastic global team environment and ample opportunities for growth and development.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer means you’re guaranteed to:

Syneos Health (Nasdaq: SYNH) 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. We support a diverse, equitable and inclusive culture.

J-18808-Ljbffr

Updated: August 25, 2025
Location: Barcelona, Spain
Job ID: -OTHLOC-3529-2DBARC-2DR

Description

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.

- Acts as lead for assigned writing projects.

- 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 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.

- Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.

- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.

- Serves as peer reviewer on internal review team providing review commentson draft and final documents.

- Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, 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.

- Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.

- Maintains awareness of 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

- 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 and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.

- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership 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.

Summary

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health (Nasdaq:SYNH) 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.

Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

Location: Madrid, Spain

Job ID: Description

Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

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 :

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.

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• 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 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; and clinical journal manuscripts, abstracts, and client presentations.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Reviews statistical analysis plans and table / figure / listing specifications for content, grammar, format, and consistency.
• Interacts with department head and staff in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
• Serves as peer reviewer on internal review team providing review comments on draft and final documents.
• Adheres to regulatory standards (ICH-E3, company SOPs, client standards, and templates) when completing medical writing projects, on time and on budget.
• Performs online literature searches, as applicable, and stays familiar with current industry practices and regulatory requirements.
• Maintains awareness of budget specifications for assigned projects, working within 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%).

• 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 and FDA and ICH regulations and guidelines, and familiarity with AMA style guide.
• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

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.

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. 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. The Company is committed to compliance with applicable laws and regulations, including the EU Equality Directive and the Americans with Disabilities Act, with reasonable accommodations where appropriate.

Strong medical writing skills and experience in lead authoring various drug regulatory documents. Ability to lead and work on multiple deliverables in parallel whilst maintaining quality and meeting agreed timelines / milestones. Opportunity to work in a fantastic global team environment and ample opportunities for growth and development.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer means you’re guaranteed to:

Syneos Health (Nasdaq: SYNH) 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. We support a diverse, equitable and inclusive culture.

J-18808-Ljbffr

Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

Location: Madrid, Spain

Job ID: Description

Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

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 :

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.

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• 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 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; and clinical journal manuscripts, abstracts, and client presentations.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Reviews statistical analysis plans and table / figure / listing specifications for content, grammar, format, and consistency.
• Interacts with department head and staff in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
• Serves as peer reviewer on internal review team providing review comments on draft and final documents.
• Adheres to regulatory standards (ICH-E3, company SOPs, client standards, and templates) when completing medical writing projects, on time and on budget.
• Performs online literature searches, as applicable, and stays familiar with current industry practices and regulatory requirements.
• Maintains awareness of budget specifications for assigned projects, working within 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%).

• 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 and FDA and ICH regulations and guidelines, and familiarity with AMA style guide.
• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

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.

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. 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. The Company is committed to compliance with applicable laws and regulations, including the EU Equality Directive and the Americans with Disabilities Act, with reasonable accommodations where appropriate.

Strong medical writing skills and experience in lead authoring various drug regulatory documents. Ability to lead and work on multiple deliverables in parallel whilst maintaining quality and meeting agreed timelines / milestones. Opportunity to work in a fantastic global team environment and ample opportunities for growth and development.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer means you’re guaranteed to:

Syneos Health (Nasdaq: SYNH) 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. We support a diverse, equitable and inclusive culture.

J-18808-Ljbffr