Regulatory Documentation Writer Stellenangebote

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Stellenangebote Regulatory Documentation Writer Jobs bei Jobleads

Job vom 11.10.2024

Lead Medical Writer (Reporting to Vice President Regulatory Affairs)

• Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen

MEHR

Your mission As a Lead Medical Writer, you will plan, author, and organize the review process of documents pertaining to clinical studies and regulatory interactions, including (but not limited to) critical sections of marketing applications, protocols, clinical study reports, briefing documents, and responses to [...] report to the Vice President of Regulatory Affairs. Responsibilities Preparation of regulatory documents for the purpose of NDA/ MAA/ IND submissions as well as briefing packages in accordance with regulatory requirements and according to agreed timelines. Leading preparation of complex documentation together with other medical writers support, e. g. , clinical Module 2 documents including ISS and ISE. Plans content and [...]
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Weitere Stellenangebote Regulatory Documentation Writer bei Jobleads

Job vor 8 Tagen gefunden

Director, Regulatory Medical Writing (1 of 4)

Führungs-/ Leitungspositionen

MEHR

Description Johnson Johnson is currently seeking a Director, Regulatory Medical Writing. The primary location for this position is the United States. Secondary locations are Canada, United Kingdom, Switzerland, Netherlands, [...] This is a global role and is open to other countries. Remote work options may be considered on a case- by- case basis and if approved by the company. The Director, Regulatory Medical Writing (RegMW) is a highly experienced medical writer and influential leader with strategic responsibilities as it relates to the delivery of high- quality regulatory documentation. This position will focus on submission strategies across multiple therapeutic areas (TAs) and is an individual contributor role. The submission [...]
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Job vor 14 Tagen gefunden

Technical Writer (m f d) for Medical Devices

• Bergisch Gladbach, Nordrhein- Westfalen

MEHR

Technical Writer (m f d) for Medical Devices For 35 years, we have been developing cutting- edge science and technology to empower [...] more than 4, 800 experts from over 50 countries contribute to our sustainable success. Job Description You will be responsible for creating and maintaining user manuals in English for our innovative medical devices, always ensuring compliance with current standards and regulatory requirements. You will organize the translation of user manuals into the languages relevant to the target market with our translation [...] You will independently plan and execute your projects while adhering to specified timelines and continuously coordinating with the relevant departments. Qualifications You hold a degree in Technical Communication, Life Sciences, or a related field. Your initial professional experience in technical documentation for medical devices will enable you to quickly adapt to this role. You have experience with documentation tools and a [...]
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Stellenangebote Regulatory Documentation Writer Jobs bei NewScientist Jobs

Job vom 26.10.2024 Richmond Pharmacology

Principal Medical Writer

• London, United Kingdom, London (Greater)

MEHR

Job Title: Principal Medical Writer Location: London Bridge (Hybrid 4 Days onsite) Term: Permanent, Full- time Salary: Competitive Salary + Benefits (Private Medical, Private Dental, [...] commitment to excellence and innovation, we strive to advance medical research and contribute to the development of life- changing therapies. The Role: We are seeking an experienced and accomplished Principal Medical Writer to lead and develop our medical writing and regulatory teams. In this senior role, you will play a pivotal part in overseeing the preparation of high- quality regulatory submissions [...] organisation and preparation of regulatory submissions, ensuring accuracy and regulatory appropriateness. Work closely with Clinical Project Delivery to support the maintenance of filing and tracking databases of company regulatory information. Medical Writing Oversee the preparation, and submission, of all study documentation in accordance with regulatory requirements. Ensure factual accuracy and regulatory compliance for all content development. Demonstrate an advanced understanding of [...]

Job vom 13.10.2024 Bio Marin Pharmaceutical Inc.

Associate Director, Clinical Medical Writing

• London, Greater London, United Kingdom, London (Greater) Führungs-/ Leitungspositionen

MEHR

[...] to patients who live with genetic diseases. SUMMARY DESCRIPTION The Associate Director of Clinical Medical Writing has administrative and functional oversight responsibilities for Medical Writing staff, including authoring/ editing documents. The Associate Director may participate in review and approval of regulatory submission documents and publications, and will work with the Head of CMW in departmental resource planning, submission planning for program [...] and budget Works with CMW line management to establish and maintain timelines for program planning. Acts as management- level author/ reviewer for CMW and other Development Sciences deliverables, where such review/ authoring is required by SOPs or other controlled process documentation Builds effective partnerships with cross- functional groups to ensure customer/ stakeholder needs are met. For outsourced projects, performs vendor management [...] consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications. EDUCATION REQUIREMENTS Masters (MS) or higher degree preferred; scientific focus desirable. Minimum requirement: At least 10- years of experience as a medical writer in the pharmaceutical industry. Evidence of medical writing career development desirable, e. g. European/ American Medical Writers Association certificate, Editor [...]
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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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Kaufmännische Tätigkeiten Regulatory Affairs & Management

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