BOLDSCIENCE’s Post

Excelling as a Mid-Level Regulatory Medical Writer: Key Skills & Activities . As a regulatory medical writer progresses to a mid-level role, the focus extends beyond crafting high-quality documents. It’s also about mastering project management and navigating complex regulatory landscapes. Here’s a glimpse into the typical activities and skills that define this pivotal stage: 🔹 Review & Feedback: Providing constructive feedback on documents created by entry-level writers, ensuring accuracy and clarity. 🔹 Collaborative Calls: Attending conference calls to align messaging across components of a New Drug Application (NDA), ensuring consistency and compliance. 🔹 Team Meetings: Contributing to discussions aimed at shortening timelines for critical documents, demonstrating efficiency and problem-solving skills. 🔹 Client Interactions: Engaging in discussions about budget, timeline, and resource needs, blending diplomacy with regulatory expertise to meet client expectations. 🔹 Leading Discussions: Facilitating roundtable meetings to address client feedback on documents, enhancing communication and project alignment. 🔹 Adaptability: Embracing the need to be organized, efficient, and flexible to deliver top-quality documents within tight deadlines. In this role, your ability to balance regulatory knowledge with project management skills will be key to achieving success. If you’re navigating this exciting career stage, these competencies will not only enhance your effectiveness but also elevate the quality of your work. #RegulatoryWriting #MedicalWriting #ProjectManagement #CareerDevelopment #NDA #ProfessionalGrowth #LifeSciences

Check out the list of job titles that can be used for a career in Medical Writing! Thanks to Gertrude Nonterah, Ph.D. for pointing out that your job search could be missing great opportunities depending on the terms you choose. #careercatalystedge

If you are an #IMG, #fmg or #doctor who enjoys writing and researching, #Medical #writing ✍️ can be your thing! Let's Keep Growing and Expanding together. 🤹 Thank you Gertrude Nonterah, Ph.D. for this post! 👉Tomorrow, on Up To Trials newsletter we will cover clear communication in clinical #trials. Link in my Bio!🫶 Best, Jennipher Gonzalez M.D. #research #clinicaltrials #uptotrials

Medical Writer Companies: Source For Trusted Health Info https://lnkd.in/geeb3r-R Finding the right medical writing company can feel like navigating through a maze. With such a variety in the industry, knowing which company excels in providing top-notch, regulatory compliant documents is crucial. This article aims to make your journey easier by providing a comprehensive list of the best providers in this field. Key Takeaways of Medical Writer Companies - Medical writing companies help make complex health data easy to understand. - They write for doctors, nurses and patients. They also help with medical research. Top companies include IQVIA, PAREXEL, Syneos Health, UDG Healthcare Plc, Trilogy Writing & Consulting and Covance. - These firms offer jobs like Associate Medical Writer to Principal Medical Writer. - Job search can be done on platforms like BioSpace or Indeed. There are many remote work options too. Need Strategic Marketing Guidance For Your Doctor's Office, Healthcare, Medical, Clinic, Medspa, Plastic or Cosmetic Surgical Practice? Schedule a Deep-Dive Marketing Analysis for Your Medical Practice: https://lnkd.in/gFAbkniJ #Healthcare #Medical #Marketing #SEO #DigitalMarketing #HealthcareMarketing #MedicalMarketing #HealthcareSEO #MedicalSEO #PlasticSurgery #CosmeticSurgery #DoctorMarketing #DoctorMarketingMD

Medical Writer Companies: Source For Trusted Health Info https://lnkd.in/guNNcTBt Finding the right medical writing company can feel like navigating through a maze. With such a variety in the industry, knowing which company excels in providing top-notch, regulatory compliant documents is crucial. This article aims to make your journey easier by providing a comprehensive list of the best providers in this field. Key Takeaways of Medical Writer Companies - Medical writing companies help make complex health data easy to understand. - They write for doctors, nurses and patients. They also help with medical research. Top companies include IQVIA, PAREXEL, Syneos Health, UDG Healthcare Plc, Trilogy Writing & Consulting and Covance. - These firms offer jobs like Associate Medical Writer to Principal Medical Writer. - Job search can be done on platforms like BioSpace or Indeed. There are many remote work options too. Need Strategic Marketing Guidance For Your Doctor's Office, Healthcare, Medical, Clinic, Medspa, Plastic or Cosmetic Surgical Practice? Schedule a Deep-Dive Marketing Analysis for Your Medical Practice: https://lnkd.in/gyHuveuC #Healthcare #Medical #Marketing #SEO #DigitalMarketing #HealthcareMarketing #MedicalMarketing #HealthcareSEO #MedicalSEO #PlasticSurgery #CosmeticSurgery #DoctorMarketing #DoctorMarketingMD

🚨 !!Medical device regulatory terms alert!!! 🚨 In this post I will talk about the Clinical Evaluation Report (CER). The CER is one of the key documents in your clinical evaluation process. It contains all the clinical evidence to demonstrate the safety, performance, and benefit of a medical device (Article 61 and Annex XIV Part A of the MDR). It is important to note that medical devices from all classes require a CER.   Key components of the CER (non-exhaustive list): ❎ Summary ❎ Purpose and scope ❎ State of the art ❎ Device under evaluation: ➡ Product information ➡ Intended purpose, target groups, (contra)indications ➡ Clinical claims with supporting clinical evidence ➡ Clinical benefits ➡ Equivalence (if applicable) ➡ Clinical data from manufacturer, literature, PMS, and PMCF ➡ Summary and appraisal of clinical data ➡ Analysis of clinical data (in terms of safety, acceptability of benefit-risk profile, performance, and acceptability of side effects) to demonstrate conformity with GSPRs ❎ Conclusion ❎ Date of next clinical evaluation ❎ Dates and signatures ❎ Qualification of the authors   ❗ Important: The CER is a living document with regular updates based on the device class or new information from the PMS that changes the current evaluation. ❗ Stay tuned for my upcoming post! Do you have any insights or questions about the Clinical Evaluation Report? Leave a comment below and share your thoughts!   ------------------------------------------------------------------------------------  If you are looking for a freelance Medical Writer, writing clinical evaluation documents for medical devices that secure compliance with regulatory requirements, please contact me 📨.    #ClinicalEvaluation #RegulatoryWriting #MedicalWriting #MedicalDevices #RegulatoryCompliance #ClinicalEvaluationReport #Freelance #MedicalWriter

🚨 !!Medical device regulatory terms alert!!! 🚨 Clinical claims are an essential part of the clinical evaluation. A medical device's clinical claims may be based on its intended purpose, safety, or performance. ✳ When it comes to clinical claims for medical devices, clarity and accuracy are important. According to Article 7 of the MDR, clinical claims for medical devices must not be misleading. ✳ Therefore, claims should be precisely defined and ensure that they accurately reflect the intended purpose, safety, and performance of the device. ✳ Claims must be supported by preclinical or clinical data. Quantification of the data based on clinical outcomes is critical. This applies not only to regulatory submissions (such as the Clinical Evaluation Report), but also to all marketing materials. Let's discuss! Share your experiences or tips on how to ensure compliance with MDR requirements. How do you quantify your claims effectively? Share your thoughts in the comment section below! 👇 -------------------------------------------------------------------------------------  If you are looking for a freelance Medical Writer, writing clinical evaluation documents for medical devices that secure compliance with regulatory requirements, please contact me 📨 . #ClinicalEvaluation #RegulatoryWriting #MedicalWriting #MedicalDevices #RegulatoryCompliance #ClinicalEvaluationReport #Freelance #MedicalWriter Image by Parentingupstream on Pixabay

I had the privilege of diving into the specialised world of regulatory medical writing with Uloaku A.. During our discussion, Uloaku shared insights into her role in preparing essential documentation that supports clinical trials and medical advancements. She emphasised the unique challenge of adapting information to meet the needs of distinct audiences, such as healthcare professionals and patients, each requiring different approaches and language styles. What struck me most was the variety in her work. Every project introduces new challenges and learning opportunities, keeping her role dynamic and continually engaging. This adaptability is crucial in medical writing, where the accuracy and clarity of information can significantly impact healthcare outcomes. Uloaku’s dedication to her craft and her skill in communicating complex medical information in accessible ways deepened my appreciation for the critical role that regulatory medical writers play in the healthcare system. For those curious about the role of medical writers, I recommend watching our conversation: https://lnkd.in/e9fsa4zU Have you ever considered the intricate details that go into the documentation for clinical trials? #RegulatoryMedicalWriting #ClinicalTrials #MedicalCommunication #HealthcareProfessionals #PatientEducation #TheProfessionalYouShouldKnow

What if you could be paid to learn as a #pharmacist? Medical affairs pharmacists typically love this profession because they spend much of their time learning and applying their knowledge in different settings. In next week's webinar, I'll specifically talk about medical writing, how to get started and get published as a writer. If you're considering going down this path for your career, or if you just want to make some extra income on the side, comment if you're interested and I'll send you the link to join.