Medical Writer
vor 6 Monaten
**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 & Respiratory; Inflammation; Oncology; CNS, retinopathies & emerging areas).
***Tasks & responsibilities**:
In your new role as Medical Writer:
- You are responsible for the preparation of clinical documents required for advancing clinical development programs (e.g. clinical trial reports, investigator’s brochures, clinical trial protocols). This includes writing, planning, developing of document strategies, resolving and integrating review comments, and overseeing of timelines.- You ensure quality of clinical documents assigned to external providers by appropriate oversight and training.- Furthermore you develop in-depth knowledge in the assigned TA and in one or more of the main document types of the function portfolio. You share knowledge with other medical writers.- You advance MW standards by contributing to process improvement initiatives and working groups with cross-functional impact.
In your new role as a Senior Medical Write r:
- You assume the role of project medical writer across all phases of clinical development. You proactively coordinate with other functions, plan timelines, and devise and execute document strategy in a clinical development program.- You are responsible for the preparation of clinical documents required for phase transitions and regulatory approval of Boehringer Ingelheim (BI) development compounds (e.g. clinical trial reports, clinical summaries, investigator’s brochures, briefing books, clinical trial protocols), regulatory documents in the post-marketing setting, and value dossiers supporting health technology assessments.- Moreover you ensure quality and timeliness of clinical documents assigned to external providers by appropriate oversight, training, budget planning, and cost control.- You contribute to BI-internal international cross-functional working groups, and global SOP development.- You assume the role of an expert in the assigned TA, including thorough knowledge and understanding of the document and analysis standards.- You transfer knowledge when mentoring and training other medical writers.
***Requirements**:
- Doctoral degree in Pharmacy, Medicine or Life Science with multiple years of experience in scientific and/or regulatory medical writing or comparable degree with long term professional experience- Sound knowledge of medical concepts, statistics, pharmacokinetics, and pharmacodynamics- Ability to independently and effectively communicate complex clinical information in writing- Ability to manage projects effectively across regions and in matrix environments- Excellent written and verbal English skills
Additional requirements for the Senior position:
- Longstanding experience in regulatory medical writing (as a Medical Writer or an equivalent role)- Proven ability to work globally on clinical documents for submission to health authorities in major regions such as US, EU and Asia- EMWA/AMWA foundation or advanced certificate is an asset
***READY TO CONTACT US?**:
Please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330.
-
Senior Medical Writer
vor 6 Monaten
Munich, Deutschland Oracle VollzeitSenior 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...
-
Medical Advisor/medical Writer
vor 6 Monaten
Munich, Deutschland Omnicom Health Group VollzeitOverview: **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...
-
Senior Medical Advisor/medical Writer
vor 5 Monaten
Munich, Deutschland Omnicom Health Group VollzeitOverview: **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...
-
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 5 Tagen
Munich, Deutschland Drapalin Pharmaceuticals GmbH VollzeitMedical 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...
-
Software Verification Engineer
vor 4 Wochen
Munich, Bayern, Deutschland L&T Technology Services VollzeitVerification Engineer OpportunityAt L&T Technology Services, we're seeking a talented Verification Engineer to join our team in designing and developing innovative class IIb medical devices. This role involves collaborating with our design and development team to establish and maintain a V&V program for new product development.Main Responsibilities:Develop...
-
Technician (M/F/d) in The Field of Medical
vor 6 Monaten
Munich, Deutschland SCINTOMICS Molecular Applied Theranostics Technologies GmbH (ATT) VollzeitScintomics Molecular, Applied Theranostics Technologies GmbH is a manufacturer of automated synthesis modules for radiopharmaceutical production with worldwide distribution. In addition, Scintomics Molecular, att GmbH distributes chemicals, precursors and disposable/consumable materials for radiopharmaceutical production of radiotracers. **To support our...
-
Pv Officer
vor 6 Monaten
Munich, Deutschland Oracle VollzeitPV Officer - Medical Review (M/F/d)-230005FC **Applicants are required to read, write, and speak the following languages***: English **Preferred Qualifications** Oracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical research...
-
Backend Engineer
Vor 6 Tagen
Munich, Deutschland Avi Medical VollzeitRemote // Full-Time // Starting ASAPBackend Engineer (all genders, Junior or Mid-Level)About AviWe are on a mission to elevate the patient experience and provide the best possible primary care by combining technology with a human touch. Avi Medical runs patient-centric, tech-enabled medical practices that provide a convenient, personalized and holistic...
-
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...
-
Senior Technical Content Specialist
Vor 4 Tagen
Munich, Bayern, Deutschland Danaher VollzeitTechnical Writer - Munich, GermanyWe are seeking a skilled Technical Writer to join our team in Munich, Germany. As a Senior Technical Writer, you will play a crucial role in creating high-quality user-oriented content for our existing product lines and new product development in an Agile environment.About the Role:Craft compelling and accurate technical...
-
Senior Technical Writer
vor 6 Monaten
Munich, Deutschland Danaher VollzeitWondering 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...
-
Verification Specialist
vor 4 Wochen
Munich, Bayern, Deutschland Technology & Strategy VollzeitJob Title: Verification SpecialistThe Technology & Strategy company is seeking a skilled Verification Specialist to support the design and development team in maintaining a Verification and Validation (V&V) program for new product development. The selected candidate will be responsible for writing, reviewing, and executing verification and validation test...
-
Working Student
vor 6 Monaten
Munich, Deutschland Brainlab VollzeitCompany Description Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25...
-
Working Student
vor 5 Monaten
Munich, Deutschland Brainlab Vollzeit**Company Description** Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2400 dedicated and inspiring individuals in 25...
-
Associate Director Scientific Communications
vor 5 Monaten
Munich, Deutschland Regeneron Pharmaceuticals Inc. VollzeitAs an Associate Director Scientific Communications, you will drive the development, alignment, and country level adaptation of the global scientific communications plan for the Oncology Medical Affairs portfolio. You will work in strategic partnership with the country level Medical Affairs Franchise Directors and the Global Lead of Scientific Communications...
-
Senior Clinical Program Lead
vor 6 Monaten
Munich, Deutschland BI International GmbH Vollzeit**The Position**: As (Senior) Clinical Program Lead (CPL) you assume full medico-scientific and strategic leadership of global clinical development programs and evidence generation for assets in the indication area Pulmonology/pulmonary fibrosis with the objective to accelerate clinical development and achieve regulatory approvals and reimbursable...
-
Working Student
vor 5 Monaten
Munich, Deutschland Brainlab VollzeitCompany Description Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25...
-
Healthcare Quality Specialist
Vor 4 Tagen
Munich, Bayern, Deutschland Elsevier Limited Company VollzeitAbout the RoleThe Lancet Regional Health – Europe is an Open Access journal under The Lancet's global health initiative, focusing on improving healthcare quality and access globally.You will work with Senior Editors and the Editor-in-Chief to prepare the journal. Collaborate with authors and editorial teams to ensure high-quality...