Principal Regulatory Medical Writer

vor 3 Monaten

Leipzig, Deutschland Thermo Fisher Scientific Vollzeit

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services part of Thermo Fisher Scientific - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

**Principal Regulatory Medical Writer (home based)**

As a Principal Medical Writer, you will serve as the primary author by writing and providing input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.

You will be a part of a team who is dedicated to its people and fosters a supportive, collaborative culture based on trust, flexibility and work-life balance. You would be able to consider the work setting where you would be most productive, able to choose being entirely remote based or work part-time of at least 25-30hours per week.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.

**Summarized Purpose**:
**Essential Functions**:

- Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
- Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
- Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.
- May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
- Represents the department at project launch meetings, review meetings, and project team meetings.

**Education and Experience**:

- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
- Experience within regulatory medical writing (comparable to 8+ years).
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- _In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered enough for an individual to meet the requirements of the role._

**Knowledge, Skills and Abilities**:

- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Excellent project management skills
- Advanced interpersonal, oral and written communication, and presentation skills
- Excellent negotiation skills
- Excellent judgment; high degree of independence in decision making and problem solving
- Ability to mentor and lead junior level staff

**What we offer**

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

**Our 4i Values**:
**Integrity - Innovation - Intensity - Involvement

  • Medical Director

    vor 2 Monaten

    Leipzig, Deutschland Velocity Clinical Research, Inc. Vollzeit

    Overview: Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We...

  • Medical Director

    vor 3 Monaten

    Leipzig, Deutschland PERMACON GmbH Berlin Vollzeit

    **PERMACON ist gern Ihr persönlicher Wegbegleiter!**: Sie bevorzugen den **Direkteinstieg**? Unser Auftraggeber, ein internationales Forschungszentrum, sucht zur Verstärkung in **Vollzeit **in Leipzig und stellt im Rahmen der **Personalvermittlung **ein: **Medical Director **(m/w/d) **Ihre Aufgaben in der klinischen Forschung als Medical Director...

  • Regulatory Compliance Manager

    vor 3 Wochen

    Leipzig, Sachsen, Deutschland BIOTYPE GmbH Vollzeit

    Company OverviewBIOTYPE GmbH specializes in the development, production, and distribution of molecular diagnostic kits and systems aimed at detecting and quantifying RNA and DNA markers. Our assays play a crucial role in the diagnosis and treatment within oncology, hemato-oncology, and forensic DNA analysis. Alongside our commercial kits, we provide tailored...

  • Regulatory Compliance Manager

    vor 2 Wochen

    Leipzig, Sachsen, Deutschland BIOTYPE GmbH Vollzeit

    Company OverviewBIOTYPE GmbH specializes in the development, production, and distribution of molecular diagnostic kits and systems designed for the detection and quantification of RNA and DNA markers. Our assays play a crucial role in the diagnosis and treatment within oncology, hemato-oncology, and forensic DNA analysis. Alongside our commercial kits, we...

  • Regulatory Compliance Specialist

    vor 2 Wochen

    Leipzig, Sachsen, Deutschland BIOTYPE GmbH Vollzeit

    Company OverviewBIOTYPE GmbH is at the forefront of developing, manufacturing, and distributing molecular diagnostic solutions aimed at the detection and quantification of RNA and DNA markers. Our assays play a crucial role in diagnosing and treating conditions in oncology, hemato-oncology, and forensic DNA analysis. Beyond our commercial kits, we specialize...

  • Regulatory Compliance Manager

    vor 2 Wochen

    Leipzig, Sachsen, Deutschland BIOTYPE GmbH Vollzeit

    Company OverviewBIOTYPE GmbH specializes in the development, production, and distribution of molecular diagnostic kits and systems designed for the detection and quantification of RNA and DNA markers. Our assays are pivotal in supporting diagnosis and therapy across oncology, hemato-oncology, and forensic DNA analysis. Beyond our commercial kits, we also...

  • Senior Regulatory Affairs Specialist

    vor 2 Wochen

    Leipzig, Sachsen, Deutschland BIOTYPE GmbH Vollzeit

    Company OverviewBIOTYPE GmbH specializes in the development, production, and distribution of molecular diagnostic kits and systems designed for the detection and quantification of RNA and DNA markers. Our assays are integral to the diagnosis and treatment in oncology, hemato-oncology, and forensic DNA analysis. In addition to our commercial offerings, we...

  • Director Medical Writing

    vor 3 Monaten

    Leipzig, Deutschland Thermo Fisher Scientific Vollzeit

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD, a Division of Thermo Fisher Scientific — thousands of employees in locations worldwide connected by tenacity and passion. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering...

  • Medical Engagement Lead

    vor 3 Monaten

    Leipzig, Deutschland Bristol-Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Senior Auditor

    Vor 3 Tagen

    Leipzig, Deutschland Life Science People Vollzeit

    Job Title: Qualified Medical Device AuditorLocation: GermanyAbout Us: I am supporting a leading Notified Body in the medical device industry, renowned for our commitment to quality and safety in the healthcare sector. They provide certification, testing, and auditing services to ensure that medical devices meet regulatory standards and contribute to patient...

  • Junior Surgeon in General and Visceral Surgery

    vor 20 Stunden

    Leipzig, Sachsen, Deutschland European Medical Consulting Adam GmbH Vollzeit

    European Medical Consulting Adam GmbH is seeking a dedicated Junior Doctor to join our esteemed medical team in Leipzig. This role offers a unique opportunity for professional growth within a modern hospital setting. Your Responsibilities: Participate actively in on-call duties, ensuring prompt and efficient patient care.Conduct thorough surgical...

  • Senior Clinical Program Lead

    vor 1 Monat

    Leipzig, Deutschland Pharmiweb Vollzeit

    Job Title: Senior Clinical Program Lead - OncologyTasks & responsibilitiesIn this role, you represent Medicine at the International Multidisciplinary Evidence Teams and you take clinical development responsibility for the projects assigned. For example: definition of Target Product Profiles, Asset Evidence Plan, Pediatric Investigational Plan, core Clinical...

  • Clinical Research Coordinator I

    vor 3 Monaten

    Leipzig, Deutschland Velocity Clinical Research, Inc. Vollzeit

    Overview: Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We...

  • Pharmazeutische Praktikumsstelle

    vor 2 Wochen

    Leipzig, Sachsen, Deutschland ELAC Elysée Apotheken Consulting GmbH Vollzeit

    Die ELAC Elysée Apotheken Consulting GmbH, die größte unabhängige Apothekenkooperation in Deutschland, ist auf der Suche nach einer/einem engagierten Pharmaziepraktikant/in für die Bereiche Regulatory/Medical Affairs. Unsere Partnerapotheken profitieren von unserem breiten Portfolio an innovativen Arzneimitteln (OTC) und Nahrungsergänzungsmitteln...

  • Pharmazeutische Praktikumsstelle

    vor 2 Wochen

    Leipzig, Sachsen, Deutschland ELAC Elysée Apotheken Consulting GmbH Vollzeit

    Die ELAC Elysée Apotheken Consulting GmbH, als führende unabhängige Kooperation von Apotheken in Deutschland, gestaltet aktiv die Zukunft unserer über 500 Partnerapotheken. Mit unseren Marken elacpharma und elacvital bieten wir unseren Partnern attraktive und innovative Produkte im Bereich der Arzneimittel (OTC) sowie Nahrungsergänzungsmittel (NEM)....

  • Pharmazeutische Praktikumsstelle

    vor 2 Wochen

    Leipzig, Sachsen, Deutschland ELAC Elysée Apotheken Consulting GmbH Vollzeit

    Die ELAC Elysée Apotheken Consulting GmbH, als führende unabhängige Apothekenkooperation in Deutschland, setzt sich für die kontinuierliche Weiterentwicklung unserer 500 Partnerapotheken ein. Mit unseren Marken elacpharma und elacvital bieten wir unseren Partnern attraktive und innovative Arzneimittel (OTC) sowie Nahrungsergänzungsmittel (NEM) an. Zur...

  • Pharmazeutische Praktikumsstelle

    vor 2 Wochen

    Leipzig, Sachsen, Deutschland ELAC Elysée Apotheken Consulting GmbH Vollzeit

    Die ELAC Elysée Apotheken Consulting GmbH, als führende unabhängige Apothekenkooperation in Deutschland, gestaltet die Zukunft unserer 500 Partnerapotheken aktiv mit. Mit unseren Marken elacpharma und elacvital bieten wir unseren Partnern innovative Arzneimittel (OTC) sowie hochwertige Nahrungsergänzungsmittel (NEM) an. Im Zuge der Erweiterung unseres...

  • Volljurist (W/m/d)

    vor 2 Monaten

    Leipzig, Deutschland European Energy Exchange AG Vollzeit

    **Your tasks**: As a Legal Counsel/fully qualified lawyer you will be part of a team of 13 lawyers supporting the various business departments within the EEX Group regarding the legal requirements that may arise in the context of being an internationally operating group (with various exchanges and clearing houses). Within a team of colleagues your main...

  • Pharmazeutische Praktikumsstelle

    vor 2 Wochen

    Leipzig, Sachsen, Deutschland ELAC Elysée Apotheken Consulting GmbH Vollzeit

    Die ELAC Elysée Apotheken Consulting GmbH, als führende unabhängige Kooperation von Apotheken in Deutschland, gestaltet die Zukunft unserer 500 Partnerapotheken aktiv mit. Mit unseren Marken elacpharma und elacvital bieten wir unseren Partnern eine breite Palette an innovativen Arzneimitteln (OTC) sowie hochwertigen Nahrungsergänzungsmitteln (NEM). Zur...

  • Data Protection Specialist

    Vor 3 Tagen

    Leipzig, Deutschland Chino.io Vollzeit

    Chino.io is the EU leader in data protection and data security for digital health. We bring together legal and technical expertise in GDPR, data security, and application development to help companies develop innovative health tech or medtech solutions and to ensure compliance of their products.We are looking for a German speaking Data Protection Specialist...