🚨 Job Alert! Organon is looking for a Director, Regulatory Medical Writing - REMOTE! 🏢 About the company: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. 👩🏽💻 About the role: Lead medical writing of clinical regulatory documents for various types of regulatory filings, including but not limited to: Protocol, Protocol Amendments & CSRs for inline trials, Agency Background Packages and Response to Agency Inquiry, 2.5 Clinical Overviews, Clinical and Non-Clinical summaries and Module 5 documents. Other responsibilities would also include maintenance of common templates and provide content management support (i.e., formatting, citations, content authoring tool workflow facilitation). This position will be required to coordinate routinely with leadership in the Product Registration (Regulatory Liaison) organization, Medical/Clinical/Safety organizations (with CRO), vendor oversight and IT. #femtech #womenshealth #womenshealthinnovation #femhealth #digitalhealth #healthcare #healthtech #healthcareinnovation #workinhealth #diagnostics #jobs #career #jobsearch #pharma #writing #medicalwriting #regulatory #workinwomenshealth
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Medical Writer | MBBS, AIIMS | Helping doctors & pharma, biotech, & medical device companies with research manuscripts, medico-marketing, SEO health articles, & more| Consulting Healthtech Startups| Medical Writing Coach
I am usually asked who actually hires medical writers. Pharmaceutical companies (#pharma) are one the biggest employers of medical writers. They usually have a lot of jobs and projects for medical writing. Here are some reasons why #pharmaceuticalcompanies require medical writers. 1. Rapid Advancements in Drug Development: The accelerated pace of drug discovery and development demands agile, insightful medical writing. Communicating complex scientific findings effectively becomes paramount as breakthrough therapies emerge. 2. Emphasis on Real-World Evidence: The industry's growing reliance on real-world evidence for drug approval necessitates skilled medical writers who can distill and communicate the real-world impact of pharmaceutical interventions. 3. Patient-Centric Approaches: With a shift towards patient-centricity, medical writers play a pivotal role in translating technical information into patient-friendly materials. Clear, accessible communication becomes crucial for informed decision-making. 4. Regulatory Landscape Complexity: Evolving regulatory requirements demand a keen understanding of compliance in medical writing. Writers must stay attuned to changes, ensuring documentation aligns with stringent standards. 5. Multichannel Communication Strategies: Pharmaceutical companies are diversifying communication channels. Medical writers must adapt to crafting content for diverse platforms, from traditional journals to digital media, to effectively disseminate information. 6. Collaboration Across Disciplines: The interdisciplinary nature of modern pharmaceutical research emphasizes the need for effective collaboration. Medical writers bridge the gap, facilitating communication between scientists, regulatory experts, and other stakeholders. For anyone looking to get into medical writing, different pharma companies are a major target group. What do you think about this? Are there any other ways pharma companies may require medical writers? #Pharmaceuticals #MedicalWriting #HealthcareInnovation #regulatorywriting #pharmacovigilance
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We support both Marketing + Medical Affairs pharma stakeholders in 30+ countries: reprints and eprints, professional medical writing, creative medcomms, medical education
Streamline Your Publications Processes: Integrated Medical Writing, Editorial, Design and Biostatistics Support 👇👇👇. As medical affairs teams in pharma/biotech, you often find yourselves coordinating with multiple internal stakeholders and providers. Managing input from all these groups while ensuring high-quality, compliant content can be a logistical nightmare when working with separate vendors for medical writing, design, and biostatistics,.. What if you could simplify this process by partnering with an agency that provides an integrated suite of these services? An experienced medical communications agency offering expert medical writers, designers and biostaticians under one roof can be a game-changer. The Benefits of a One-Stop Shop: ⚡Time Savings - No more juggling different schedules, processes and communication channels across several vendors ⚡Seamless Collaboration - Writers, designers and stat experts work as one cohesive unit, enhancing workflow efficiency ⚡Consistency - A unified team provides greater content consistency for manuscript developments, CSR reports. Having supported top pharmaceutical companies worldwide, Content Ed Net understands the unique challenges you face. From streamlining vendor oversight to simplifying confidentiality agreements and contracting, we make medical communications hassle-free. Whether developing manuscripts & publications, training materials or meetings outputs, entrust your medical communications to our integrated team. Reach out to learn how I can support your upcoming projects while reducing administrative burdens. #redactionmedicale, #medicalwriting, #reprints, #medecine, #medicalinformation, #pharmaceutical, #biotechnology, #marketing #pharmaceuticalindustry, #NEJM, #industriepharmaceutique, #affairesmedicales, #intelligenceartificielle
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Biobank | Biosafety | Researcher | Virologist |Aptamers | Microbiologist | Entrepreneurial Mindset for Innovation |Biosafety
#recruitment alert #openpositions See the link below for more information and to apply! To #stayinformed on the latest #jobopenings & #openpositions by #connecting with me on LinkedIn! #jobs #openpositions #Biotechjobs #microbiologyjobs #lifesciencejobs #MolecularBiologyJobs #careeroppurtunities #Labopportunities #ResearchJobs #LifeSciCareers #clinicalresearch #opportunities2024 #postdoc
Vacancy for #Medical Writer Organisation: Eccentric Clinical Research Private Limited Job Type: Full Time Experience: 3-5 years of experience in medical writing, preferably in the pharmaceutical or CRO Industry. If interested, please share your CV at: hr@eccentriccr.com NOTE: Mention "CV for Manager- Medical Writing" in the subject line while sending the email. #medicalwriting #medicalwriter #mw #medicalwriterjobs #vcancy #cro #newgenerationcro #greatopportunity #ECR #Eccentricclinicalresearch #eccentriccr
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📚 Excited to be a part of the Dynamic World of Medical/Pharmaceutical Writing! 🌐🩺 Dear all Healthcare Professionals, I am thrilled to share with you my passion for medical and pharmaceutical writing, as I embark on this exciting journey in the ever-evolving world of healthcare communication! 🚀 As a medical writer and I am committed to bridging the gap between complex scientific information and the broader audience, from healthcare professionals to patients seeking valuable insights. 🔬 Precision and Clarity: Medical/Pharmaceutical writing demands the highest level of accuracy and clarity. I take pride in my ability to meticulously research and interpret scientific data, translating it into compelling content that is both informative and accessible for Healthcare Professionals/Patient and General Public. 🌟 Advancing Healthcare Knowledge: Being a part of this field allows me to contribute to the advancement of medical research and practice. I firmly believe that effective science communication plays a pivotal role in improving patient outcomes and public health 📖 Diverse Writing Projects: My expertise spans various types of medical documents, including scientific manuscripts, clinical trial protocols, regulatory submissions, medical marketing materials, continuing medical education content, and patient education resources. 📰 Stay Updated: In this rapidly evolving industry, staying updated with the latest advancements, guidelines, and regulatory changes is crucial. I am committed to continuous learning to provide the most up-to-date and relevant information. 💡 Looking Forward: I am excited about the opportunities that lie ahead in the medical and pharmaceutical writing sphere. Whether it's driving awareness about breakthrough therapies, enhancing patient education, or supporting cutting-edge research, I am eager to make a positive impact. 💌 Let's Connect: I am open to collaborating with like-minded professionals, sharing knowledge, and exploring new opportunities in the field of medical/Pharmaceutical writing. Feel free to connect with me here or drop me a message! Thank you for being a part of my network and supporting me on this incredible journey. Together, let's make a difference in healthcare through effective communication and dissemination of medical information. 🙌 #MedicalWriting #PharmaceuticalWriting #HealthcareCommunication #ScienceCommunication #MedicalWriter #HealthcareIndustry #PatientEducation #ScienceWriter #HealthcareCommunity #HealthcareProfessionals #ContinousLearning
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Regulatory submissions ✦CTD ✦ ACTD ✦ MHRA ✦ PDRs ✦ Pharmaceutical blogs ✦Medical writing ✦Pre-Clinical study reports ✦Dossier writing ✦ Pharmacology ✦ Highly motivated ✦ Will to do new things
What is the scope of #medicalwriting ? . . . . Medical writing is a specialized field that involves the creation of various types of documents related to #medicine and #healthcare. The scope of medical writing is broad, and professionals in this field play a crucial role in communicating #scientific and #medicalinformation to different audiences. Here are some key aspects of the scope of medical writing: 📌 Clinical Trial Protocols: Describing the objectives, design, methodology, and statistical considerations of a clinical trial. 📌 Clinical Study Reports (CSRs): Summarizing the results and findings of clinical trials. 📌 Regulatory Documents: *Common Technical Document (CTD): Compiling documentation required for regulatory submissions to health authorities. *Investigator's Brochure (IB): Providing an overview of the drug or medical device under investigation. 📌Scientific Publications: *Journal Articles: Writing and editing research papers for publication in scientific journals. *Abstracts and Posters: Summarizing research findings for presentation at conferences. 📌Educational and Training Materials: *Educational Resources: Developing materials for healthcare professionals, patients, and the general public. *Training Manuals: Creating materials for the training of healthcare professionals and researchers. 📌Medical Communications: *Medical Science Liaison (MSL) Documents: Supporting the communication between pharmaceutical companies and healthcare professionals. Medical Affairs Documents: Providing information for internal and external stakeholders. 📌Patient Communication: *Patient Information Leaflets: Creating documents to inform patients about their medical conditions, treatments, and medications. The demand for skilled #medicalwriters is growing as the pharmaceutical and healthcare industries continue to advance. Medical writers need a strong understanding of #scientificprinciples, excellent #writingskills, and the ability to #communicate complex information in a clear and concise manner. What do you think about the scope of Medical writing in #Pakistan????
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Why do you need a medical writer for medical devices? Here's a few reasons... 1. Regulatory Compliance: Complex Regulations: Medical devices are subject to stringent regulations and standards enforced by regulatory agencies such as the FDA (in the United States), the European Medicines Agency (EMA), and others globally. Medical writers are well-versed in these regulations and can ensure that all documentation complies with them. Documentation Requirements: Regulatory submissions for medical devices typically involve extensive documentation, including pre-market applications, post-market surveillance reports, clinical evaluation reports, and labeling requirements. Medical writers can navigate these requirements efficiently, ensuring completeness and accuracy. 2. Communication with Diverse Stakeholders: Physicians and Healthcare Professionals: Medical devices often require clear, concise, and user-friendly instructions for healthcare professionals who use and maintain them. Medical writers can create user manuals and training materials that are comprehensible to these audiences. Patients: For devices that are used directly by patients (e.g., insulin pumps or home monitoring devices), patient-facing materials like brochures, websites, and instructions need to be written in a way that patients can understand. Medical writers can translate complex technical information into patient-friendly content. Regulatory Authorities: Effective communication with regulatory authorities through submission documents, responses to queries, and post-market surveillance reports is vital. Medical writers ensure that these communications are precise and well-structured. 3. Scientific and Technical Expertise: Understanding of Device Functionality: Medical writers possess a deep understanding of medical device technology and functionality. This enables them to accurately describe how a device works and its intended use in regulatory submissions and marketing materials. Data Interpretation: Medical device trials generate significant data, and medical writers can interpret and present this data in a way that supports the device's safety and efficacy claims. 4. Risk Management and Safety: Risk Assessment: Medical device documentation must include thorough risk assessments and mitigation strategies. Medical writers can collaborate with risk management experts to incorporate this critical information into documents. #medicaldevices #medicalwriting #regulatorywriting #scientificwriting #medicalcommunications
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In healthcare, it's really important to communicate information clearly and accurately. Medical writing is like a bridge that helps make complicated medical information easier to understand for everyone. - Complex to Simple: Medical writing simplifies complex medical information for easy understanding by everyone involved. - Accuracy & Clarity: Medical writers ensure that information is accurate, clear, and free from mistakes, preventing confusion or errors. - Navigating Compliance: With knowledge of healthcare regulations, medical writers help companies follow the rules and obtain necessary approvals. - Fostering Collaboration: Medical writing facilitates communication among doctors, researchers, patients, and others, promoting effective teamwork. How Medcytes Will Help? Medcytes provides expert medical writers who transform intricate medical details into comprehensible content, helping companies in explaining, complying, and collaborating effectively. #medicalwriting #research #pharma #pharmaceutical #medicalwriter
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Developing clinical regulatory documents such as investigators brochures, protocols, clinical study reports, CTD submission documents, briefing packages, and different types of Health Authority interactions, often falls into the hands of the Medical Writer. But what sets a professional Medical Writer apart? 🧐 ⤵️ Is it merely about understanding data and having proficiency in English? Far from it. Let's delve into the unique blend of skills that experienced Medical Writers bring to the table... ☆ Multidisciplinary collaboration: Medical Writers frequently collaborate with researchers, medical experts, statisticians, and other pivotal skill areas. Skilled Medical Writers are able to bridge the gaps between such stakeholders, understand their perspectives, and synthesize their input. ☆ Expert content knowledge: Medical writing involves interpreting, visualizing and presenting different types of scientific and medical data. Medical Writers must understand how to effectively communicate complex concepts in a clear, concise, and accessible way – ensuring technical and scientific accuracy while optimising readability. ☆ IT tools and regulatory knowledge: Having experience with and focus on the use of emerging IT tools for efficient writing and data interpretation, as well as a solid knowledge of regulatory requirements and new standards is key. ☆ Reaching the target audience: Medical Writers must adapt their writing style and language to suit the target audience, which can vary from regulatory authorities to healthcare professionals and even patients. Finding the right balance between technical accuracy and readability is essential. Mastering these skills requires a combination of subject matter expertise, strong research understanding, effective communication, a collaborative mindset, attention to detail, and continuous professional development. That's why our Medical Writers all have more than 10 years of experience with development of clinical regulatory documents from the pharmaceutical industry or academia. 💬 𝐍𝐞𝐞𝐝 𝐚𝐬𝐬𝐢𝐬𝐭𝐚𝐧𝐜𝐞? Reach out to Birgitte Sloth on LinkedIn, or at BiSl@pharmait.dk
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"Critical Thinking" in Medical Writing: Why and How? (cont...) How does “Critical Thinking” empower medical writers? Avoiding commercial bias: Medical writers play a key role in bridging the gap between pharmaceutical companies and the public. They must navigate this delicate balance without giving in to commercial prejudices. Critical thinking allows writers to objectively assess data and present information without compromising the integrity of the message. Resisting pressure for favourable reporting: In an industry where success is often measured by positive outcomes, there can be pressure to report favorable results or interpretations of clinical trials. Critical thinking empowers medical writers to resist such pressures and uphold ethical standards, ensuring that the information presented is an accurate reflection of the data at hand. Guarding against selective reporting: Reporting results selectively may influence public perceptions of a drug's effectiveness or safety profiles. Critical thinking prompts medical writers to evaluate their work, ensuring that all relevant data – irrespective of the outcomes – is included. This commitment to completeness fosters transparency and strengthens the credibility of the communication. In conclusion, by inculcating critical thinking, medical writing professionals pave the way for a future where medical communications inspire trust, and empower informed decision-making for healthcare professionals. #criticalthinking #medicalwriters #scientificcommunication #evidencebasedmedicine #medicomarketing #datatransparency #healthcarecommunications
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