Senior Medical Writer

vor 6 Monaten


Munich, Deutschland Oracle Vollzeit

Senior Medical Writer (M/F/d)-230005DW

**Applicants are required to read, write, and speak the following languages***: English

**Preferred Qualifications**

Oracle Germany are looking for a Senior Medical Writer who has experience writing regulatory & safety documents.

**MISSON**:

- Compile, write, and edit medical writing deliverables covering all phrases of clinical research for submission to regulatory agencies.
- Creation of documents, point of contact for clients, writes simple proposals and methodology sections of more complex proposals with input from Team Leader
- Writing of study reports for non-interventional and clinical studies
- Write scientific copies for a broader audience, including scientific liaisons, healthcare professional, and pharmaceutical representatives.
- Creation of components of submission dossiers dossiers (modules of the Common Technical Document [CTD]), and safety reports (Periodic Benefit-Risk Evaluation Reports [PBRER] / Periodic Safety Update Reports [PSUR], Post Market Surveillance Reports [PMSRs] and Development Safety Update Reports [DSUR])
- Supports Drug Safety Officer in creation of narrative safety reports and corresponding inquiries
- Develops relationships with clients and is considered a point of contact by clients for project requests / questions
- Writes simple proposals and methodology sections of more complex proposals with input from Team Leader Medical Writing or Directors
- Prioritizes workload with mínimal input from Team Leader Medical Writing to ensure agreed deadlines are met
- Manages workload of their self and others to ensure that agreed deadlines are met
- Develops own knowledge and personal skills in line with business requirements
- Provides expertise to internal and external stakeholders to ensure all materials and publications comply with relevant SOPs, regulations and guidelines.
- Demonstrates maturity in the assessment of own learning and development needs
- Keeps abreast of developments in the pharmaceutical industry
- Identifies and develops new ways of working to ensure continuous business improvement
- Preparation of other project-specific documents such as observational plans and study protocols
- Ensure all deliverables are in accordance with regulations, standards, and guidelines.
- Conduct comprehensive literature searches to enhance background understanding and evaluate and analyze information covered in the writing.
- Prepare abstracts, scientific exhibits, posters and verbal presentations.
- Develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations.
- Compile, write, and edit medical writing deliverables covering all phrases of clinical research for submission to regulatory agencies.
- Creation of documents, point of contact for clients, writes simple proposals and methodology sections of more complex proposals with input from Team Leader
- Writing of study reports for non-interventional and clinical studies
- Write scientific copies for a broader audience, including scientific liaisons, healthcare professional, and pharmaceutical representatives.
- Creation of components of submission dossiers dossiers (modules of the Common Technical Document [CTD]), and safety reports (Periodic Benefit-Risk Evaluation Reports [PBRER] / Periodic Safety Update Reports [PSUR], Post Market Surveillance Reports [PMSRs] and Development Safety Update Reports [DSUR])
- Supports Drug Safety Officer in creation of narrative safety reports and corresponding inquiries
- Develops relationships with clients and is considered a point of contact by clients for project requests / questions
- Writes simple proposals and methodology sections of more complex proposals with input from Team Leader Medical Writing or Directors
- Prioritizes workload with mínimal input from Team Leader Medical Writing to ensure agreed deadlines are met
- Manages workload of their self and others to ensure that agreed deadlines are met
- Develops own knowledge and personal skills in line with business requirements
- Provides expertise to internal and external stakeholders to ensure all materials and publications comply with relevant SOPs, regulations and guidelines.
- Demonstrates maturity in the assessment of own learning and development needs
- Keeps abreast of developments in the pharmaceutical industry
- Identifies and develops new ways of working to ensure continuous business improvement
- Preparation of other project-specific documents such as observational plans and study protocols
- Ensure all deliverables are in accordance with regulations, standards, and guidelines.
- Conduct comprehensive literature searches to enhance background understanding and evaluate and analyze information covered in the writing.
- Prepare abstracts, scientific exhibits, posters and verbal presentations.
- Develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations.
-


  • Medical Writer

    vor 6 Monaten


    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **THE POSITION**: “Making science clear to improve patients’ lives.” At Global Medical Writing, we provide end-to-end contributions to clinical development programs by writing key regulatory clinical documents. We currently have opportunities for (Senior) Medical Writers in our Therapeutic Area (TA) Medical Writing (MW) teams (CardioMetabolism &...


  • Munich, Deutschland Omnicom Health Group Vollzeit

    Overview: **Job Title**:Senior Medical Advisor/Medical Writer **Department**:Medical **Reports to**:Group Medical Director **Tasks**: The Medical team’s primary focus is to provide medical consultation and scientific background for campaigns and projects. It also advises clients and agency-members. In this context the medical team always ensures and...


  • Munich, Deutschland Omnicom Health Group Vollzeit

    Overview: **Job Title**: Medical Advisor/Medical Writer **Department**:Medical **Reports to**: Group Medical Director **Tasks**: The Medical team’s primary focus is to provide medical consultation and scientific background for campaigns and projects. It also advises clients and agency-members. In this context the medical team always ensures and provides...

  • Medical Writer

    vor 7 Monaten


    Munich, Deutschland Syneos Health Clinical Vollzeit

    **Description** **You are able to create strong, lasting relationships to ensure needs and goals are met.** The primary purpose of this role is to support the medical team on the day-to-day running of the client projects. This will include the writing and proof reading of medical content in the areas of Advertising and PR communication, as well as working...

  • Medical Writer

    Vor 3 Tagen


    Munich, Deutschland Drapalin Pharmaceuticals GmbH Vollzeit

    Medical Writer (m⁠/⁠w⁠/⁠d) – Arbeiten, wann und wo Du willst.Die Drapalin Pharmaceuticals GmbH ist seit 2017 als pharmazeutischer Großhändler für medizinisches Cannabis etabliert und fest im deutschen Markt verankert. Unser Unternehmen engagiert sich mit hochwertigen pflanzlichen Arzneimitteln für die Zukunft der Medizi...


  • Munich, Bayern, Deutschland Danaher Vollzeit

    Unlock Your Potential in Technical WritingAt Danaher, we're committed to advancing science and technology to improve patient lives. As a Senior Technical Writer, you'll play a crucial role in creating high-quality, user-oriented content for our medical devices.About the RoleAs a member of our Technical Documentation Department, you'll work closely with...

  • (Senior) Medical Advisor

    vor 5 Monaten


    Munich, Deutschland Apellis Pharmaceuticals Vollzeit

    **Position: (Senior) Medical Advisor DACH** **Reports to: Director Medical Affairs DACH** **Location: preferably Munich office-based or hybrid Germany** **Position Summary**: The Senior Medical Advisor DACH provides strategic alignment with International and Country Medical Affairs (MA) plans. He/she supports the full scope of medical affairs activities...


  • Munich, Bayern, Deutschland FSQ Functional Safety & Quality Experts GmbH Vollzeit

    FSQ Experts GmbH offers innovative solutions to overcome know-how or resource bottlenecks in medical technology companies. Our experts contribute to the certification of safe medical devices while promoting a quality and safety culture.We are looking for a Senior Medical Devices Expert to join our team. This role involves supporting the development of...


  • Munich, Bayern, Deutschland FSQ Functional Safety & Quality Experts GmbH Vollzeit

    About FSQ Functional Safety & Quality Experts GmbHFSQ Functional Safety & Quality Experts GmbH is a leading provider of innovative solutions for medical technology companies. Our team of experts helps clients overcome know-how and resource bottlenecks in quality management, regulatory affairs, and system engineering.Job DescriptionWe are seeking a highly...


  • Munich, Bayern, Deutschland Snke OS Vollzeit

    Company OverviewSnke OS is a leading innovator in patient-privacy-centered ecosystem development, revolutionizing data-driven healthcare with cutting-edge visualization technologies.Job Title: Senior Medical Software EngineerSalary Range: €80,000 - €110,000 per annum, depending on experienceJob Description:Contribute to the development and implementation...


  • Munich, Bayern, Deutschland NVIDIA Vollzeit

    Key Responsibilities:We are seeking a highly skilled and experienced professional to join our team as a Senior Account Manager, Medical Devices. The ideal candidate will have a strong background in the healthcare industry and excellent communication skills.Key Accountabilities:Act as the primary point of contact for medical device manufacturers and life...

  • Content Writer

    vor 5 Monaten


    Munich, Deutschland Simon-Kucher & Partners Vollzeit

    **Content Writer (M/F/d)**: **In Germany**: - Berlin | Bonn | Cologne | Frankfurt/Main | Hamburg | Munich As Content Writer you will be creating content for various departments and employees of the company (including senior stakeholders in the business). You will be a part of the Global Marketing Department, working in one of our offices in Germany or in...

  • Verification Engineer

    vor 4 Wochen


    Munich, Bayern, Deutschland Technology & Strategy Vollzeit

    Job Title: Verification Engineer - Medical DevicesThe Technology & Strategy team is seeking a skilled Verification Engineer to support the design and development of medical devices. As a key member of our team, you will be responsible for maintaining a V&V program for new product development, ensuring that our products meet the highest standards of quality...


  • Munich, Bayern, Deutschland FSQ Functional Safety & Quality Experts GmbH Vollzeit

    FSQ Experts GmbH is a leading provider of innovative solutions for medical technology companies. We offer precise and pragmatic support to overcome know-how or resource bottlenecks in quality management, regulatory affairs, and system engineering.Our team of experts is dedicated to promoting a systematic approach for mastering complexity and contributing to...

  • Senior Technical Writer

    vor 5 Monaten


    Munich, Deutschland Beckman Coulter Diagnostics Vollzeit

    **Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.** At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...

  • Senior Technical Writer

    vor 5 Monaten


    Munich, Deutschland Beckman Coulter Diagnostics Vollzeit

    **Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.** At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...


  • Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: **Senior Medical Director, Global Specialty Medical Affairs (GSMA), Medical Information and Education (MI&E) (M/F/x)**: **The position**: The Senior Director Global Specialty Medical Affairs (level is contingent upon past experiences and qualifications) is a critical GSMA member for non-oncology products....

  • Medical Monitor

    vor 2 Wochen


    Munich, Deutschland Jobactive GmbH Vollzeit

    Medical Monitor / Senior Clinical Project Manager (w/m/d) JETZT BEWERBEN Ihre Aufgaben:Sie unterstützen als Medical Monitor die Projektmanager bei...


  • Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    The Senior Director, Global Oncology Medical Affairs is responsible for developing the Global Medical Affairs (GMA) strategy and tactical plan as part of the Global Brand Strategic Plan and leads the execution of the activities in the GMA plan including Launch Readiness and Life Cycle Management for the assigned compound and will report into the Global...


  • Munich, Bayern, Deutschland FSQ Functional Safety & Quality Experts GmbH Vollzeit

    At FSQ Functional Safety & Quality Experts GmbH, we are looking for a talented Technical Senior Consultant to join our team of experts.The ideal candidate will have relevant experience in the role of technical consultant and a strong background in the technical development of medical device products.Key responsibilities include:Supporting the development of...