Aktuelle Jobs im Zusammenhang mit Clinical Regulatory Documentation Expert - Berlin, Berlin - Certara
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Regulatory Writer
vor 3 Wochen
Berlin, Berlin, Deutschland Certara VollzeitCertara is seeking a highly skilled Principal Regulatory Writer to join our team. As a key member of our regulatory writing team, you will be responsible for preparing high-quality documentation for regulatory submissions to help streamline the regulatory documentation process for our clients. The ideal candidate will have a strong understanding of...
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Regulatory Writer
vor 4 Wochen
Berlin, Berlin, Deutschland Certara VollzeitJob Title: Principal Regulatory Writer (PRW) - ClinicalCertara is seeking a highly skilled and experienced Principal Regulatory Writer (PRW) to join our team. As a PRW, you will be responsible for leading the development of high-quality regulatory documents for our clients, ensuring compliance with global health authority requirements.Responsibilities:Lead...
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Clinical Regulatory Writer
vor 3 Wochen
Berlin, Berlin, Deutschland Certara VollzeitCertara Clinical Regulatory Writer - PrincipalAbout CertaraCertara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.Clinical...
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Regulatory Writer
vor 1 Monat
Berlin, Berlin, Deutschland Certara VollzeitOverviewCertara is a leading provider of biosimulation software, technology, and services that accelerate the development of medicines. We work with over 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.Job SummaryWe are seeking a highly experienced Principal Regulatory Writer to join our team. As a key...
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Regulatory Writer
vor 1 Monat
Berlin, Berlin, Deutschland Certara VollzeitOverviewCertara is a leading provider of biosimulation software, technology, and services that accelerate the development of medicines. We work with over 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.Job SummaryWe are seeking a highly experienced Principal Regulatory Writer to join our team. As a key...
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Clinical Regulatory Writer
vor 3 Wochen
Berlin, Berlin, Deutschland Certara VollzeitCertara Career OpportunityAt Certara, we accelerate medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.Job SummaryWe are seeking a highly skilled...
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Regulatory Writer
vor 3 Wochen
Berlin, Berlin, Deutschland Certara VollzeitAbout CertaraCertara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.Job SummaryWe are seeking a highly skilled Regulatory Writer...
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Senior Clinical Research Associate
vor 3 Wochen
Berlin, Berlin, Deutschland Worldwide Clinical Trials VollzeitAbout the RoleAt Worldwide Clinical Trials, we are seeking a highly skilled Senior Clinical Research Associate to join our team. As a Senior Clinical Research Associate, you will be responsible for managing clinical trials from start to finish, ensuring that all aspects of the trial are conducted in accordance with regulatory requirements and Good Clinical...
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Regulatory Writer
vor 2 Monaten
Berlin, Berlin, Deutschland Certara VollzeitJob Title: Principal Regulatory Writer (PRW) - ClinicalCertara is seeking a highly skilled Principal Regulatory Writer (PRW) to join our team. As a PRW, you will be responsible for leading the development of high-quality regulatory documents for our clients.About CertaraCertara accelerates medicines using proprietary biosimulation software, technology, and...
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Regulatory Writer
vor 2 Monaten
Berlin, Berlin, Deutschland Certara VollzeitJob Title: Principal Regulatory Writer (PRW) - ClinicalCertara is seeking a highly skilled Principal Regulatory Writer (PRW) to join our team. As a PRW, you will be responsible for leading the development of high-quality regulatory documents for our clients.About CertaraCertara accelerates medicines using proprietary biosimulation software, technology, and...
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Clinical Research Associate
vor 2 Wochen
Berlin, Berlin, Deutschland Worldwide Clinical Trials VollzeitAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Worldwide Clinical Trials. As a Clinical Research Associate, you will be responsible for conducting remote psychiatric patient interviews for clinical trials, preparing scoring rationale for interviews, and entering data following each interview.Key...
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Senior Clinical Research Associate
vor 3 Wochen
Berlin, Berlin, Deutschland Oxford Global Resources VollzeitJob SummaryWe are seeking a highly experienced Senior Clinical Research Associate to join our team in the Medical Devices sector. As a Senior CRA, you will play a key role in the execution of clinical studies to assess the safety and effectiveness of Medical Devices products.Key ResponsibilitiesParticipate in clinical research site management, qualification,...
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Senior Clinical Research Associate
vor 4 Wochen
Berlin, Berlin, Deutschland Oxford Global Resources VollzeitJob Title: Senior Clinical Research AssociateWe are seeking an experienced Senior Clinical Research Associate to join our team at Oxford Global Resources. As a Senior CRA, you will play a key role in the execution of clinical studies to assess the safety and effectiveness of Medical Devices products.Responsibilities:Participate in clinical research site...
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Senior Clinical Research Associate
vor 4 Wochen
Berlin, Berlin, Deutschland Oxford Global Resources VollzeitJob Title: Senior Clinical Research AssociateWe are seeking an experienced Senior Clinical Research Associate to join our team at Oxford Global Resources. As a Senior CRA, you will play a key role in the execution of clinical studies to assess the safety and effectiveness of Medical Devices products.Responsibilities:Participate in clinical research site...
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Senior Clinical Research Associate
vor 4 Wochen
Berlin, Berlin, Deutschland Oxford Global Resources VollzeitJob Title: Senior Clinical Research AssociateAre you an experienced professional in clinical research and medical devices looking for a challenging role with minimal travel? We are seeking a Senior Clinical Research Associate to join our team and support the execution of clinical studies to assess the safety and effectiveness of Medical Devices products.Key...
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Senior Clinical Research Associate
vor 4 Wochen
Berlin, Berlin, Deutschland Oxford Global Resources VollzeitJob Title: Senior Clinical Research AssociateAre you an experienced professional in clinical research and medical devices looking for a challenging role with minimal travel? We are seeking a Senior Clinical Research Associate to join our team and support the execution of clinical studies to assess the safety and effectiveness of Medical Devices products.Key...
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Senior Clinical Research Associate
vor 4 Wochen
Berlin, Berlin, Deutschland Worldwide Clinical Trials VollzeitJoin Our Team at Worldwide Clinical TrialsWe are a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality.Our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and...
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Senior Clinical Research Associate
vor 4 Wochen
Berlin, Berlin, Deutschland Worldwide Clinical Trials VollzeitJoin Our Team at Worldwide Clinical TrialsWe are a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality.Our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and...
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Clinical Research Associate Oversight Manager
vor 3 Wochen
Berlin, Berlin, Deutschland Oxford Global Resources VollzeitJob DescriptionAs a Clinical Research Associate Oversight Manager at Oxford Global Resources, you will be responsible for overseeing a team of CRAs in the execution of clinical studies in the area of neurovascular or peripheral vascular therapies.Supervise a team of CRAs located in different EU countries.Support the team with the planning and execution of...
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Senior Clinical Research Associate
vor 2 Wochen
Berlin, Berlin, Deutschland Worldwide Clinical Trials VollzeitGlobal Partnership in Clinical Trials:At Worldwide Clinical Trials, we work in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications from discovery to reality.We have a dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, which enables us to...
Clinical Regulatory Documentation Expert
vor 2 Monaten
Certara is a leading provider of biosimulation software, technology, and services that accelerate the development of medicines. Our clients include over 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.
Job SummaryWe are seeking a highly experienced Regulatory Writer to join our team as a Principal Regulatory Writer (PRW). As a PRW, you will be a key contributor to the development of high-quality regulatory documentation for our clients. You will lead project teams, mentor junior staff, and ensure that all regulatory documents meet the highest standards of quality and compliance.
Responsibilities- Lead the development of strategies for organizing and preparing regulatory documents for our clients.
- Manage project teams and actively participate in the development and writing of high-quality documents, including study-level and submission-level documents, pharmacovigilance documents, and clinical study reports.
- Serve as a liaison and subject matter expert internally and for clients, guiding and advising them on strategies and best practices for achieving approval and agreement from regulatory authorities.
- Author documents per client specifications, templates, style guides, and other guidance documents.
- Author documents per regulatory authority guidelines and requirements.
- Act as a client advisor and proactive consultant to collaborate and anticipate the needs of the client based on the relationship and knowledge while looking for new business opportunities.
- Take ownership of entire deliverables, including multiple writers, and manage budgets for all types of projects.
- Usher documents through the review process, conduct comment resolutions meetings, and successfully lead project teams to consensus.
- Maintain collaborative, proactive, and effective communication with both client and internal teams.
- Lead project-related meetings and teleconferences and coach others in same.
- Provide coaching to junior staff for all documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements.
- Bachelor's degree (minimum)
- 10+ years of regulatory writing experience with clinical-related documentation
- Understanding of regulatory requirements for different phases of development and different regulatory pathways
- Knowledge of global health authority requirements
- Collective experience writing and leading a range of documents in their entirety (e.g. study and submission level, pharmacovigilance)
- Strong understanding of the document creation process and of the drug development lifecycle
- Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
- Able to synthesize data across multiple data sources and documents to create summary reports
- Practice blameless problem solving, effectively managing all crisis communications, managing risks, and realizing business opportunities
- Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders
- Ability to lead submission-level sections (clinical documents, e.g. Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE) taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
- Ability to lead sub-teams for deliverables (e.g., pharmacovigilance documents, transparency & disclosure deliverables), taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
- Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
- Ability to identify potential problems, promptly tackling those problems, particularly in sensitive or high-pressure situations
- Possesses broad experience and technical expertise across more than one therapy area and integrate this knowledge to deliver business successes and actively transfer this knowledge to strengthen the skill base across the organization
Certara bases all employment-related decisions on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
