Regulatory Writing Stellenangebote in Nordrhein-Westfalen

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Stellenangebote Regulatory Writing Nordrhein-Westfalen Jobs bei Jobleads

Job vom 15.10.2024

Pharmacovigilance Officer/ EU- QPPV (Reporting to the Chief Medical Officer)

• Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen

MEHR

[...] role of the Pharmacovigilance Officer is of the highest importance. Bringing broad knowledge to the drug safety function, you are embedded into Ai Curis project teams and support drug development related to all aspects of pharmacovigilance during discovery, drug development, regulatory review and approval. One of the long- term goals of this role is to extend the Ai Curis drug safety [...] system and establishing its system master file Ensuring adherence to the GVP modules as defined by the European Commission Continuous observation of the regulatory landscape and scientific literature regarding pharmacovigilance Reviewing and amending safety information within development documents Responsible for writing and reviewing adverse event narratives and periodic reports Responsible for standard operating procedures in pharmacovigilance, regular updates and training adherence [...]
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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 agency requests for information. In this role, you will need to apply critical thinking, scientific writing, data interpretation, and knowledge of regulatory content life- cycle. You will oversee and coordinate other external writers assisting on documents [...]

Stellenangebote Regulatory Writing Nordrhein-Westfalen Jobs bei StepStone

Job vom 22.10.2024 ISCC System GmbH

(Senior) Project Manager Climate Strategy/ Carbon Project Certification

• Köln Homeoffice möglich Sabbaticals Jobticket Work-Life-Balance

MEHR

[...] management Proven hands- on experience in Climate Strategy development for clients Deep knowledge of net- zero and climate neutrality targets, including SBTi Advance knowledge of carbon markets (Regulated and Voluntary) and understanding of the key drivers, market trends, and impacting regulatory frameworks Deep understanding of and (ideally) working experience with international certification standards (VCS, CMD, Gold Standard, Climate Pal) Experience in [...] of advantage Knowledge and experience on (climate) finance and risk analysis will be an assett Excellent written and spoken communication skills in English and German (both at least C1) ; speaking other languages would be of advantage Excellent and proven writing skills with regards to proposals, project documentation and reporting Results oriented and very attentive to details Very strong presentation skills [...]

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Stellenangebote Regulatory Writing Nordrhein-Westfalen Jobs bei Neuvoo

Job vor 13 Tagen gefunden iO Associates Head of Product (Regulatory) • Aachen, North Rhine- Westphalia Führungs-/ Leitungspositionen

MEHR

Head of Regulatory Affairs Projects Location: Hybrid- 1 day per week on- site in Aachen, Germany. Salary: 80. 000 to 120. 000 per [...] primary regulatory contact for both internal teams and external partners. Spearhead the registration and market introduction of our flagship product. Preparation of technical documentation/ RA dossiers, working closely with internal and external teams. Initially taking a hands- on approach to writing regulatory documents. Ensure compliance with quality management standards, including ISO 13485 and 21 CFR 820. What Were Looking For:Passionate about [...]
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Stellenangebot Regulatory Writing Nordrhein-Westfalen Job bei PAION Pharma GmbH

Job vom 27.10.2024 PAION Pharma GmbH

Clinical Development Manager (m/f/d)

• Aachen, North Rhine- Westphalia Homeoffice möglich Work-Life-Balance

MEHR

[...] Develop and maintain long- term professional relationships with medical specialists, healthcare professionals, key opinion leaders and clinical study investigators Develop clinical trials and studies (RCT, NIS, RWE, register, survey, etc. ) for PAION Pharma s medicinal products per global strategy, regulatory requirements and scientific needs Write clinical trial/ study documents like protocol, informed consent form, various study plans, clinical study report [...] life- cycle. Proven track record of designing clinical trials and study protocols as well as supervision of ongoing clinical trials and studies The ability to understand, process, communicate and present scientific information to a high standard Precise expressiveness, excellent medical writing skills of clinical trial/ study protocols and related study documents as well as articles for publication Demonstrative external customer focus [...]
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Job vom 03.10.2024 Third Republic Dev Ops Engineer • Ratingen, North Rhine- Westphalia

MEHR

[...] consulting firm. They enjoy immense reputation in the area of company formation and management. The company has helped numerous domestic and foreign companies with right guidance. Their mission is to protect their clients against prevailing business uncertainties and state imposed regulatory compliances. They want to consolidate position in the market and so they are aggressively investing on technology. The company is [...] in Dev Ops Experience in test- driven development in continuous integration anddeployment Familiar with containerization/ automation tools such as Kubernetes, Docker, Grafana, Prometheus, Jenkins Prior experience in agile software development (Scrum) Good communication skills Good German language skills in both writing and speaking Your Benefits: Attractive salary up to 70000 p. a Other benefits and perks 12510625 [...]

Stellenangebot Regulatory Writing Nordrhein-Westfalen Job bei Element Solutions Inc

Job vom 27.09.2024 Element Solutions Inc

Wastewater Coordinator (f/m/d)

• Langenfeld (Rheinland) , North Rhine- Westphalia

MEHR

[...] the efficient treatment and disposal of all types of waste and ensuring the air and water quality in technical building units. This role includes maintaining and documenting the wastewater pretreatment systems and organizing the external waste disposal in compliance with regulatory requirements. Who are You?Completed vocational training as a waste management specialist, surface finisher, chemical technician, or a related field2- 3 [...] operating and maintaining wastewater pretreatment systems and circulation systems, as well as water quality testing Organizational skills for waste disposal and documentation Safety awareness and the ability to implement safety instructions Strong communication skills and teamwork ability, with experience in writing reports Basic mathematical skills for technical tasks Ability to work independently and solve problems effectively Proficiency in common office applications [...]

Stellenangebot Regulatory Writing Nordrhein-Westfalen Job bei Synpulse Schweiz AG

Job vom 13.09.2024 Synpulse Schweiz AG Analytics Engineer • Düsseldorf, North Rhine- Westphalia

MEHR

[...] robust, scalable, and efficient data solutions using industry best practices and cutting- edge technologies. Collaborate with stakeholders to understand and translate business requirements into technical specifications and actionable plans. Architect and implement software systems that adhere to industry standards and regulatory requirements. Conduct code reviews and provide technical guidance, and mentor junior team members to foster a culture of continuous learning [...] and interpersonal skills, with the ability to effectively collaborate with cross- functional teams and communicate technical concepts to non- technical stakeholders Strong analytical and problem- solving skills, with the ability to think critically and strategically about complex technical challenges Experience writing data transformation and application code, particularly in Python and Typescript/ Javascript Experience with Spark and big data technology Familiarity with [...]
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Job vom 22.08.2024 Viatris

Head of Site EHS (m/f/d)

• Troisdorf, North Rhine- Westphalia Führungs-/ Leitungspositionen Work-Life-Balance

MEHR

[...] capital expenditure. Ensure the accurate and timely collection, reporting and diagnosis of EHS data to identify trends and areas for focused improvement. Manage all EHS activities with a hands- on approach. Ensure EHS input to major projects and all related regulatory and compliance issues. Ensure input in energy management systems. About Your Skills Experience For this role, we re looking for [...] line manage a team. Familiarity with regulatory compliance procedures, publications, and an ability to interpret relevant legislation. Strong logical and clear- thinking individual. The maturity and professionalism to deal with colleagues in a factual and cordial manner and capable of writing concise and clear report commentary. Team player who fosters good will and respect in the immediate and greater team environment. [...]

Job vom 15.08.2024 Lenio Bio GmbH Senior/ Principal Scientist, Late- stage CMC Downstream Technical Development (all genders) • Aachen, North Rhine- Westphalia

MEHR

[...] ALiCE protein production platform, we seek an experienced Late- Stage CMC Protein Purification expert with demonstrated Leadership ability for scale- up and process development of the protein production platform, to lead technology transfer activities to clients/ CDMOs and to support regulatory filings. Your responsibilities You will be responsible for Late- Stage CMC activities for our protein production platform ALiCE. This includes: [...] in late- stage biologics programs, including process characterization studies, process validation, and risk management (e. g. FMEA) have GMP manufacturing experience (as a plus) are an expert in scaling purification processes for the production of therapeutic proteins have supported the writing of regulatory submissions to FDA/ EMA/ MHRA etc have demonstrated Leadership ability to create and execute functional plans and lead [...]
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Stellenangebot Regulatory Writing Nordrhein-Westfalen Job bei Pharm Eng Technology

Job vom 14.08.2024 Pharm Eng Technology

CQV Engineer

• Leverkusen, North Rhine- Westphalia

MEHR

[...] the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years. Our 300+ global consultants have expertise in Commissioning Qualification, Validation, Quality Systems, Engineering, Medical Devices, Modular Cleanrooms, Thermal Mapping, Training, Toxicology and Regulatory Affairs. Pharm Eng Technology is a cGMP compliant leader with international offices in Canada, Spain, France, Germany, Austria, Switzerland, Italy, [...] this position. This position will require availability to travel. Tasks Commissioning, qualification, and requalification of new or existing manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines such as GMPs or FDA. Qualification of computerized and automation systems. Writing of the corresponding qualification documents such as VP, IQ, OQ, PQ and PPQ protocols and reports, risk assessments, and development [...]

Job vom 30.07.2024 QIAGEN Finance/ Accounting Manager Türkiye, UAE, Saudi Arabia (m/f/d) • Hilden, North Rhine- Westphalia

MEHR

[...] located in our Headquarters in Hilden, Germany, which is close to Duesseldorf. Key Responsibilities: Participate in monthly, quarterly, and year- end closing processes for group reporting (U. S. GAAP) . Prepare annual statutory accounts and corporation tax returns for local regulatory authorities. Lead and manage the accounting department in Ankara (2 team members) . Conduct financial review and control activities (fluctuation [...] and Microsoft Office, especially Excel. Strong understanding of relevant VAT legislation. Knowledge of local GAAP, US GAAP, and Sarbanes- Oxley. Leadership experience with a solid grasp of management principles and practices. Fluent in Turkish and English, both verbally and in writing, across all hierarchical levels and with external authorities. This role includes occasional travel to Türkiye. German language skills are beneficial, [...]
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Stellenangebot Regulatory Writing Nordrhein-Westfalen Job bei KBR

Job vom 19.07.2024 KBR

LCV APS- 2 Germany: HSE Supervisor

• Dülmen, North Rhine- Westphalia Führungs-/ Leitungspositionen

MEHR

[...] over 6, 000 people representing 40 nationalities who perform work on the contract in 14 countries. Job Summary As a Health, Safety Environmental (HSE) Supervisor, you will be involved in implementing and managing HSE policies and procedures, ensuring compliance with regulatory standards, and fostering a culture of safety within the organization. In this role you will report directly to the PMO [...] and reduce incidents. Coordinate the delivery of HSE products and services to operations and shared services personnel, in support of business execution. Interface and negotiate with regulatory bodies, clients, customers, and subcontractors. Execute the processes that directly impact training, report writing, plan development and implementation. Incorporate health standards directed by regulatory agencies and clients to prevent hazards and diseases from work [...]

Job vom 19.07.2024 KBR LCV APS- 2 Germany: Senior HSE Specialist • Dülmen, North Rhine- Westphalia

MEHR

[...] 40 nationalities who perform work on the contract in 14 countries. Job Summary As a Senior Health, Safety Environmental (HSE) Specialist you will be involved in implementing and managing health, safety, and environmental (HSE) policies and procedures, ensuring compliance with regulatory standards, and fostering a culture of safety within the organization. In this role you will report to the PMO Senior [...] Regulations (29 CFRs 1904, 1910, and 1926) and host nation legislation. Must have excellent problem- solving skills and the ability to develop and improve processes. Requires experience mentoring more junior team members. Must be fluent in English (speaking, reading, and writing) . Must have effective communication and interpersonal skills. Ability to work in outdoor environment to include extreme cold and/ or [...]

Job vom 29.06.2024 KBR

LCV APS- 2 Germany: Deputy Task Order Manager- Maintenance

• Dülmen, North Rhine- Westphalia

MEHR

[...] other data sources to control budgets and provide proper financial decisions. Aid in developing and implementing strategies to achieve program objectives safely and within agreed time, cost, technical, quality, and other performance criteria. Develop acquisition strategies/ plans and other statutory/ regulatory documentation (writing, editing, cross- walking, and compliance checking) , briefings and white papers supporting acquisition decisions at each of the milestones. Participate [...]

Stellenangebot Regulatory Writing Nordrhein-Westfalen Job bei DNV

Job vom 29.06.2024 DNV Senior Consultant Energy Markets and Strategy • Bonn, North Rhine- Westphalia Beratungs-/ Consultingtätigkeiten Homeoffice möglich

MEHR

Consulting . DNVs Energy Markets and Strategy (EMS) team provides economic, strategic, regulatory, and policy advisory services related to energy markets, energy infrastructures, energy technologies, and business models. To further grow our services [...] energies, as well as the assessment and valuation of energy assets, investments and business models. Guiding project team members and less experienced colleagues. Driving the continuous development and expansion of our services, including identifying market opportunities, acquiring new projects and writing winning proposals. The EMS teamThe team located in Bonn (Germany) is providing economic and commercial advice on the energy sector [...]
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Stellenangebot Regulatory Writing Nordrhein-Westfalen Job bei IQVIA

Job vom 29.06.2024 IQVIA

Contract Negotiator FSP

• Dortmund, North Rhine- Westphalia

MEHR

[...] requirements and/ or the RSU Management Plan. Provide specialist legal, operational, and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Contribute to the collection, interpretation, analysis, and dissemination of accurate contracting intelligence to support assigned studies and the wider [...] research organization clinical site contracting experience, including demonstrable global and/ or regional experience acting as a contract negotiator. Equivalent combination of education, training, and experience. Good negotiating and communication skills with ability to challenge. Strong legal, financial and/ or technical writing skills. Good understanding of clinical trial contract management. Ability to utilise metrics and then communicate these with study team to [...]

Job vom 29.06.2024 Freshfields Bruckhaus Deringer Knowledge Lawyer EU Capital Markets and Listed Companies (m/w/x) • Düsseldorf, North Rhine- Westphalia

MEHR

[...] company knowhow to lawyers in relevant teams across our Continental European practice (and, where relevant, updating lawyers in other regions) to maximise efficiency and minimise risk in line with business priorities. They will monitor and provide expert insights into EU regulatory developments that are relevant to the European capital markets and to companies with a debt and/ or equity listing in [...] pursue business opportunities and raise profile in accordance with the firm s strategy and priorities including fostering their own external network. Drive the practice s approach to the market by identifying opportunities for client- facing knowledge products and thought leadership, writing blogs, alerts, briefings and other client content, and contributing to larger publications and articles, in all cases demonstrating the practice [...]

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Technik & Ingenieurwesen Technische Dokumentation / Redaktion

Dauer: 0,2021 s., Vers. V.2025-a-2002-Ind