Regulatory Documentation Writer Stellenangebote

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Stellenangebote Regulatory Documentation Writer Jobs bei StepStone

Stellenangebot Regulatory Documentation Writer Job bei Dr. Falk Pharma GmbH

Job vor 6 Tagen gefunden Dr. Falk Pharma GmbH

Medical Writer (m/f/d)

• Freiburg Homeoffice möglich

MEHR

[...] therapeutic practice as well as patient health and well- being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for: Your main responsibility will be to edit and/ or write regulatory and clinical content and documentation, related to new drugs or clinical trials You will draft and manage regulatory and clinical research healthcare documents, including articles [...] questions, please do not hesitate to contact us at personal drfalkpharma. de or call + 49 761 1514- 102. We look forward to receiving your application via our online portal. . Dr. Falk Pharma GmbH sucht in Freiburg eine/n Medical Writer (m/f/d) (ID- Nummer: 11845508) 27225703 [...]
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Stellenangebote Regulatory Documentation Writer Jobs bei Jobleads

Job vor 8 Tagen gefunden

Senior Technical Writer/ Documentation Specialist (f/m/d)

• München, Bayern

MEHR

Your Responsibilities You will create and manage clear, concise documentation for mechatronic and robotic systems, helping users operate our technologies safely and effectively Your main tasks include producing user manuals, technical guides, and technical documents that are comprehensive, correct, and user- friendly You will set up and maintain documentation management systems to ensure all documents are properly stored, versioned, and easily accessible Ensuring compliance with regulatory standards and internal quality requirements will be a key part of your role, maintaining consistency across all documentation You will [...]

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Stellenangebote Regulatory Documentation Writer Jobs bei Neuvoo

Job vor 6 Tagen gefunden Dr. Falk Pharma GmbH Medical Writer (m/f/d) • Freiburg im Breisgau, Baden- Württemberg

MEHR

[...] as well as patient health and well- being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for: Your tasks Your main responsibility will be to edit and/ or write regulatory and clinical content and documentation, related to new drugs or clinical trials You will draft and manage regulatory and clinical research healthcare documents, including articles [...]

Stellenangebot Regulatory Documentation Writer Job bei Danaher

Job vor 11 Tagen gefunden Danaher

Senior Technical Writer (m/f/d)

• Munich, Bavaria

MEHR

[...] working at the pace of change to improve patient lives with diagnostic tools that address the world s biggest health challenges. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time. As the Senior Technical Writer (m/f/d) for Beckman Coulter Diagnostics, you take a leading role supporting the Technical Documentation Department with its project deliverables and processes. As a member of project teams, you use your advanced skills in technical [...] class Technical Documentation organization read on. In this role, you will have the opportunity to:Ensure high quality and technical accuracy of content (you adhere to the company s style guides, terminology guidelines, and relevant best- practice guidelines) and compliance with regulatory requirements. Effectively communicate project status and issues to the Technical Publications Project Manager and/ or other stakeholders, as required. Develop [...]

Job vor 13 Tagen gefunden Danaher Senior Technical Writer (m/f/d) • München, Bavaria

MEHR

Stellenangebot Regulatory Documentation Writer Job bei Kelvion Holding GmbH

Job vom 29.11.2024 Kelvion Holding GmbH

Manager Standards Documentation (m/f/d)

• Herne, North Rhine- Westphalia

MEHR

Manager Standards Documentation (m/f/d) at Kelvion Holding GmbH softgarden View job here Manager Standards Documentation (m/f/d) Full Time Hybrid Von- der- Heydt- Straße [...] as One Kelvion, our global team delivers innovative solutions that drive customer success and support a sustainable future. Kelvion Together, We Shape the Future To strengthen our technology department, we are looking for a: Manager Standards Documentation (m/f/d) Technical Editor/ Writer Were seeking engineering talent to join one of our EMEA locations to drive our technology function and help shape the [...] materials, and manufacturing processes Ensure compliance with international and industry- specific standards Collaborate with cross- functional teams to establish consistent engineering and production practices aligned with company goals Periodically review and update standards to reflect advancements in technology, materials, and regulatory requirements Create, manage, and maintain a centralized repository for all technical documentation, including design guidelines, material specifications, test protocols, and [...]

Stellenangebot Regulatory Documentation Writer Job bei Merck KGaA, Darmstadt, Germany

Job vom 17.08.2024 Merck KGaA, Darmstadt, Germany

Principal Medical Writer

• Darmstadt, Hesse

MEHR

Healthcare . As a Principal Medical Writer you will play a pivotal role in leading the Medical Writing efforts for Marketed Products and Lifecycle Management, both globally and at regional/ local levels. This includes independently preparing or overseeing the preparation of clinical and regulatory documents such as Protocols, Clinical Study Reports, Investigator Brochures, or Clinical Summary documents. You will also be responsible for supporting [...] and resource management. Extensive knowledge of regulatory requirements and industry standards in medical writing, combined with proficiency in Microsoft Office and electronic document management systems. Excellent verbal and written communication skills in English, essential for clear and effective collaboration and documentation. Demonstrates a strong commitment to innovation, integrity, and excellence, along with a dedication to continuous improvement and adherence to ethical [...]

Job vom 29.06.2024 PRA Principal Medical Writer Homeoffice möglich

MEHR

Healthcare . As a Principal Medical Writer you will be joining the world s largest most comprehensive clinical research organisation, powered by healthcare intelligence. As principal medical writer, you will be supporting a Top- 5 biotech company. You have the chance to help our customer to deliver best- in- class regulatory and submission documents. While being stably employed with ICON, you will be fully embedded with our client. Your excellence in [...] leadership and clinical teams to set up and safeguard challenging project deadlines. Functional Leadership You will be a pivotal member of clinical teams in pro- actively guiding them on best- in- class medical writing processes. You will drive consistency of documentation using document templates and company style guide across programs Ensure dissemination of industry and health- authority regulatory guidelines. Represent medical [...]

Stellenangebote Regulatory Documentation Writer Jobs bei NewScientist Jobs

Job vor 13 Tagen gefunden Stemline Therapeutics

Sr Medical Writer- UK

• Wooburn, Buckinghamshire, United Kingdom, Buckinghamshire

MEHR

Overview Senior Medical Writer (Clinical and Regulatory Medical Writing) Location: United Kingdom (remote) Reports to Head of Medical Writing Opportunity As a Sr Medical Writer, you will [...] results, and presenting conclusions to various audiences. Excellent command of Microsoft Word and authoring documents in an online environment (e. g. , MS Share Point) . Ability to work effectively in a collaborative team environment, incorporating multiple perspectives. Strong organisation, documentation, and communication skills with the ability to multitask. Flexibility and ability to adjust to changing demands and priorities, meeting challenges [...]

Job vor 14 Tagen gefunden Gilead Sciences, Inc.

Senior Manager, Medical Writing Oncology

• Uxbridge, United Kingdom, London (Greater)

MEHR

[...] Job Description POSITION OVERVIEW: Medical Writing acts as a strategic partner across drug discovery, development, and commercial teams. Medical Writing participates in cross- functional drug discovery, development and commercial product lifecycle management and contributes strategic, expert input into scientific and regulatory content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross- functionally to advance [...] successful licensure and maintenance of licensure of Gilead s medicinal products and proprietary methodologies and technologies across Gilead therapeutic areas (TAs) and in all markets around the world. We have an exciting and unique opportunity for a senior level medical writer (Senior Manager, Medical Writing, Oncology) to join our dynamic team. You will author a wide range of regulatory documents independently, [...] Knowledge Other Requirements Demonstrated ability to be a fast learner. Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/ expertise where needed. Recognized as a SME in a broad range of regulatory documentation and a resource for specialist advice and guidance. In- depth knowledge of relevant health authorities, including system, processes and requirements. [...]
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Job vom 11.12.2024 Ipsen Pharma Medical Writer, Non- Clinical H/ F • London, United Kingdom, London (Greater)

MEHR

Title: Medical Writer, Non- Clinical H/ F Company: Ipsen Biopharm Ltd Job Description: Summary/ purpose of the position To generate consistently high- quality documentation content, working across multiple accounts and projects seamlessly. The incumbent is a contributing scientific expert across therapy areas and can accurately incorporate strategic concepts into projects whilst guiding others. In addition to this, the incumbent is responsible for preparing regulatory documents for submission to regulatory authorities within subject area (non clinical focus) . Working with minimal guidance, the incumbent will [...]

Job vom 11.12.2024 Ipsen Pharma Senior Medical Writer f/m • London, United Kingdom, London (Greater)

MEHR

Title: Senior Medical Writer f/m Company: Ipsen Biopharm Ltd Job Description: Summary/ purpose of the position To generate consistently high- quality clinical documentation content, working across multiple accounts and projects seamlessly. The incumbent is a contributing scientific expert in their allocated therapy areas and can accurately incorporate strategic concepts into projects. In addition to this, the incumbent is responsible for preparing regulatory documents for submission to regulatory authorities within subject area (clinical/ safety) . Working with minimal guidance, the incumbent will take [...]

Job vom 09.12.2024 Ergomed Senior Medical Writer (Pharmacovigilance aggregate reports) - Homebased in Europe • Guildford, United Kingdom, Surrey Work-Life-Balance

MEHR

[...] Ergomed Group, a specialised mid- size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. Prime Vigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining [...] and in turn nurtures an environment from which a high- quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient s lives. Job Description The Prime Vigilance Senior Medical Writer position offers a unique opportunity to further develop your career in the field of drug safety. Key Responsibilities Independent authoring, [...] responsibility for the quality and content of the document and compliance with internal and external standards Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing, including internal templates and formats required for standardised documentation Support in all pharmacovigilance operations associated with medical writing Continuous self- education in all aspects associated with medical writing Managing [...]
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Job vom 12.10.2024 Bio Marin Pharmaceutical Inc. Principal Clinical Medical Writer • London, Greater London, United Kingdom, London (Greater)

MEHR

[...] clinical research and the associated groups that support those endeavors. Our teams work on developing first- in- class and best- in- class therapeutics that provide meaningful advances to patients who live with genetic diseases. SUMMARY DESCRIPTION The Principal Clinical Medical Writer has functional oversight responsibilities for medical writing staff and for the medical writing requirements for clinical development programs, including authoring/ [...] clinical study reports Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator s brochures and periodic safety reports (e. g. PBRERs, DSURs) Drafts and edits documents used in the preparation of regulatory filings (e. g. briefing books, CTD Module 2/ Module 5 clinical or integrated summaries) . Manages study team participation in [...] Sciences department and organizational goals. Filling this need with a regular full- time employee will enable Bio Marin to reduce writing- related CRO and contractor costs, increase Clinical Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications. EDUCATION Masters (MS) or [...]

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