Sponsor Dedicated Principal Medical Writer

vor 4 Monaten

Home Office, Schweiz Syneos - Clinical and Corporate - Prod Vollzeit

**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**

The Principal Medical Writer will be responsible for the development of clinical documents for submissions to regulatory authorities globally.

Works directly with multidisciplinary project team members with the goal of writing scientifically valid, complete, and consistent documents such as clinical study protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), clinical Module 2 summary documents, and other regulatory documents.

Role will be for the IAI Medical Writing Team, occasionally will assist the Oncology Medical Writing Team.

Looking for someone at principal level, comfortable with submissions and ideally could lead the submission process.

Will be involved with writing strategic parts of submission and will lead that process for other team members.

Location Europe or US

**#LI-NC1**

**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.
- Must have been a Senior Medical Writer in a CRO or Pharmaceutical company working within a clinical writing role. 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-NC1

  • Sponsor Dedicated Medical Editor Ii

    vor 1 Woche

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **Medical Editor II** 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...

  • Principal Medical Writer

    vor 7 Monaten

    Home Office, Schweiz ICON Vollzeit

    As 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**: - Develop regulatory documents for submission to regulatory agencies globally, including **Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and...

  • Cra, Sponsor Dedicated, Switzerland

    vor 1 Woche

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **CRA, sponsor dedicated, full-time, permanent, home-based role, in Switzerland (we are flexible to adjust the level of the role to your experience) - fluent EN, DE and FR required** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product...

  • Sponsor Dedicated Sr Clinical Editor

    vor 4 Monaten

    Home Office, Schweiz Syneos - Clinical and Corporate - Prod Vollzeit

    **Description** **Senior Medical Editor** 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...

  • Executive Medical Director in Oncology

    vor 7 Monaten

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** Here at Syneos Health, we are looking for an **Executive Medical Director to work sponsor dedicated. **You will have the chance to work in exciting studies in Oncology. The job location is** Home Based in France or Netherlands.** **Summary** This position is responsible for providing leadership and establishing strategy and implementing...

  • Cra (All Levels), Sponsor Dedicated, Home-based

    vor 1 Woche

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **Clinical Research Associate** 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...

  • Medical Writer

    vor 7 Monaten

    Home Office, Schweiz MoonLake Immunotherapeutics Vollzeit

    **Your mission**: As a (Senior) Medical Writer, you are an integral part of MoonLake’s Clinical Development team responsible for providing medical writing support to our clinical development programs including preparation, development, review, revision and finalization of clinical, medical and regulatory documents for submission to external stakeholders...

  • Medical Writer and Peer Reviewer Pool

    vor 7 Monaten

    Home Office, Schweiz H+O communications Ltd. Vollzeit

    Wir sind eine Full-Service-Agentur für medizinische Kommunikation und ein Verlagshaus in Zürich und erweitern unseren Pool an erfahrenen, freiberuflichen Medical Writern und Peer Reviewern für unsere Journale - Verfassen und Entwickeln von Kongress-Highlights, E-Learning-Modulen, medizinischen Berichten und Peer-Review-Publikationen in einer Vielzahl von...

  • Clinical Trials Assistant

    vor 7 Monaten

    Home Office, Schweiz IQVIA Vollzeit

    The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas. You will be involved in data...

  • Sponsor Dedicated Manager, Clinical Operations

    vor 2 Wochen

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **FSP Manager, Clinical Operations - COL's/CTM's** 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...

  • Sr Project Manager

    Vor 3 Tagen

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **Senior Project Manager** 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...

  • Sr Biostatistician

    vor 7 Monaten

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **Medical Affairs - Senior Biostatistician** 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...

  • Experienced Cra

    vor 7 Monaten

    Home Office, Schweiz IQVIA Vollzeit

    When you join IQVIA as an **Experienced** **CRA or SrCRA (m/w/d) **in our sponsor-dedicated department,** home-based throughout Switzerland**, you will enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our clients. Whether you're just starting out or looking to deepen your...

  • Research/writer (Diversity in Technology) Volunteer

    vor 7 Monaten

    Home Office, Schweiz women++ Vollzeit

    women++ is a Swiss non-profit association based in Zürich dedicated to increasing gender diversity in the Swiss tech industry. We are committed to helping people and companies to increase and harness diversity & inclusion in order to improve the quality of their products & working environments. Are you interested? Ask us more about our initiatives and...

  • Principal Biostatistician

    vor 3 Wochen

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    **Description** **Principal Biostatistician** 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...

  • Global Medical Director, Allergy

    vor 4 Monaten

    Home Office, Schweiz Thermo Fisher Scientific Vollzeit

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office - When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion...

  • Global Regulatory Medical Device, Combination

    vor 4 Stunden

    Home Office, Schweiz Sobi Vollzeit

    At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of rare disease patients. and our edge comes from our team of people. **Role & Function** **Key Responsibilities** - Lead New Product Development for Medical Devices (including...

  • Research/writer (Educational Tech Content) Volunteer

    vor 7 Monaten

    Home Office, Schweiz women++ Vollzeit

    women++ is a Swiss non-profit association based in Zürich dedicated to increasing gender diversity in the Swiss tech industry. We are committed to helping people and companies to increase and harness diversity & inclusion in order to improve the quality of their products & working environments. Are you interested? Ask us more about our initiatives and...

  • Wissenschaftlicher Mitarbeiter

    vor 3 Wochen

    Home Office, Schweiz IGES Institut Vollzeit

    Die Position befindet sich bei unserer Tochtergesellschaft HealthEcon AG in Basel. Die HealthEcon AG wurde 1981 als Beratungsunternehmen im Gesundheitswesen gegründet und ist seit 2012 Teil der IGES Gruppe. Kern unserer Arbeit ist die Planung und Durchführung von HTAs, epidemiologischer Recherchen, gesundheitsökonomischer Analysen sowie die Entwicklung...

  • Eu Central Medical Science Liaison

    vor 4 Monaten

    Home Office, Schweiz Viatris Vollzeit

    Viatris Pharma GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...