Principal Medical Writer
ICON
Principal Medical WriterAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise. As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information.What You Will Do:You will oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations.Key responsibilities include:Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarityCollaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document developmentProviding guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standardsMentoring and training junior medical writers, fostering a culture of excellence and professional growthStaying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputsActing as a lead medical writer for complex projects and leading clinical/regulatory marketing approval applications for new biologics and drugsThe position includes all duties of a Senior Medical Writer, as well as leadership of regulatory approval application writingYour Profile:You will have solid experience in medical writing, with the ability to manage competing priorities and develop your team.Required qualifications and experience:A bachelor's degree in life sciences, pharmacy, or a related disciplineSignificant experience in medical writing, particularly in regulatory submissions and clinical documentationStrong understanding of regulatory requirements and industry standards for clinical writingExceptional writing and editing skills, with a keen eye for detail and clarityExcellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholdersEmployment with ICON is contingent upon having the legal right to work in the country where the role is based.Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.Benefits may include:Competitive base salary and performance related incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location.Visit our careers site to read more about the benefits ICON offers.Inclusion and AccessibilityICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
- ...Senior Medical WriterAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.As... ...treatments that benefit patients worldwide.As a Senior Medical Writer at ICON, you will lead the development and execution of medical...SuggestedWorldwide
- Johnson & Johnson Innovative Medicine is seeking a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This hybrid role can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; or Horsham, PA. You will lead complex regulatory strategies for...Principal
- Johnson & Johnson’s Discovery Oncology Statistics team seeks a Senior Principal Statistician to provide strategic statistical leadership for oncology drug discovery programs in the US. Lead statistical strategy, apply advanced modeling, AI/ML, and biomarker analytics to...Principal
- ...Role Senior Principal Statistician within Johnson & Johnson's Discovery Oncology Statistics team, providing strategic statistical leadership for oncology drug discovery programs. Responsibilities Lead statistical strategy, apply advanced modeling, AI/ML, and biomarker...PrincipalRemote work
$117k - $184.2k
...Merck seeks a senior medical writer to develop clinical regulatory and public-facing documents within the Clinical and Regulatory Strategic Communications department. The role requires independent preparation of protocols, study reports, informed consent forms, and plain...SuggestedWork at office- Johnson & Johnson's Biologics Discovery seeks a Principal Scientist and Team Lead in Protein Purification. The role focuses on advancing therapeutic antibodies, multispecifics, and recombinant proteins for preclinical studies. You will lead a team, define purification strategies...Principal
- Johnson & Johnson is seeking a Clinical Pharmacology (CP) Principal Scientist to lead PK/PD analyses, PK/PD modeling, and MIDD applications across development programs. You will author CP sections for regulatory submissions and influence study designs in collaboration with...Principal
- Johnson & Johnson Innovative Medicine seeks a Principal Scientist, Biostatistics to provide expert statistical input across research, clinical development, and manufacturing programs. You will design and interpret studies, support regulatory submissions, and lead methodological...PrincipalRemote job
- Merck & Co., Inc. in the United States is seeking an Associate Principal Scientist to advance biologics pipeline programs. You will lead process characterization, scale-up, transfer and process validation activities to support late-stage and commercial products. The role...Principal
- Scorpion Therapeutics in Spring House, PA seeks a Principal Laboratory Automation Scientist in R&D to define and advance integrated laboratory automation architectures for biopharmaceutical discovery platforms. You will collaborate with automation engineers, scientists,...Principal
- Scorpion Therapeutics is seeking a Lead statistician to oversee safety analyses in Oncology programs as part of the CSS group, providing scientific expertise and strategic oversight for safety analyses throughout the product lifecycle. You will partner with cross‑functional...Principal
- ...Principal Project ManagerFort Washington, Pennsylvania, United StatesAbout the Job Principal Project ManagerJob Title: Principal Project Manager (Domain: Banking)Job Type: ContractJob Location: Fort Washington, PennsylvaniaOverview: The Principal Project Manager leads...Principal
- Johnson & Johnson in Spring House, PA is seeking a Principal Scientist, High-Content Imaging, to advance therapeutic discovery across Immunology, Neuroscience, and Oncology. You will design and execute end-to-end imaging workflows in 2D/3D models, develop novel molecular...Principal
- Role Principal Scientist in High-Content Imaging within Johnson & Johnson's Innovative Medicine division, focusing on advancing therapeutic discovery in Immunology, Neuroscience, and Oncology. Responsibilities include developing, validating, and deploying complex high-content...Principal
- Role Principal Scientist, Biostatistics at Johnson & Johnson's Innovative Medicine division, providing expert statistical input across research, clinical development, and manufacturing programs. Responsibilities design and interpret studies support regulatory submissions...PrincipalRemote work
- Role Principal Scientist and Team Lead in Protein Purification within Johnson & Johnson's Biologics Discovery, focusing on advancing therapeutic antibodies, multispecifics, and recombinant proteins for preclinical studies. Responsibilities Responsibilities include building...Principal
- Role: Lead statistical safety evaluation within the CSS group for Oncology Therapeutic Area programs, providing scientific expertise and strategic oversight for safety data analyses throughout the product lifecycle. Responsibilities: partner with cross-functional teams ...Principal
- Principal Biostatistician - United States (Remote) ICON is a global healthcare intelligence and clinical research organisation united... ...related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and...PrincipalRemote work
- Role Principal Scientist, CMC Regulatory Affairs - Combination Products, providing regulatory expertise for drug-device combination products involving both pharmaceutical and medical device components. Responsibilities Developing regulatory strategies for clinical, marketing...Principal
- Role Principal Laboratory Automation Scientist in R&D Electrical/Mechatronic Engineering, focused on defining and advancing integrated laboratory automation architectures for biopharmaceutical discovery platforms. Responsibilities Responsibilities include establishing cross...Principal
$137k - $235.75k
...Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This... ...expert interpretation of global combination product and medical device regulatory requirements and advise multiple project teams...PrincipalLocal areaImmediate start$190.8k - $300.3k
...Description Our Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and... ...regulatory challenges with rigor and professionalism. The Senior Principal Scientist, Regulatory Affairs Liaison is responsible for the...PrincipalLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$190.8k - $300.3k
Job Description The Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison reports to the Executive Director or Associate... ...comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee...PrincipalFor contractorsLocal areaRemote workWorldwideRelocationVisa sponsorshipFlexible hoursShift work- ...path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Principal Scientist, High-Content Imaging role as part of Mechanistic & Cellular Pharmacology located in Spring House, PA. Purpose: The...PrincipalLocal area
- ...units on cooling water systems, pumps, valves, and heat exchangers for existing or new power plants, with opportunities for senior or principal growth. You will deliver precise drawings, calculations, and analyses while adhering to standards and client requirements, and you...Principal
- ENERCON is seeking a Mechanical Design Engineer to join our Nuclear Design Group in full-time roles at Senior or Principal levels, located in King of Prussia, PA, with opportunities to lead and mentor others. The position involves designing mechanical systems for power...PrincipalFull time
$137k - $235.75k
...Senior Principal Scientist role leading regulatory strategy and compliance for combination products at Johnson & Johnson's Innovative Medicine division. Reports to senior management and provides expert guidance on global regulatory requirements, drug-device integration...Principal$110k - $166k
Roquette is a family‑owned global leader in plant‑based ingredients and a leading provider of pharmaceutical excipients. Want to help us make a difference? Using plant‑based resources, we collaborate with our customers and partners to imagine and offer ingredients to ...Principal$231.9k - $365k
Merck's Research Laboratories seeks an experienced veterinary pathologist to lead nonclinical drug safety assessments for oncology, immunology, vaccines, and biologics candidates. The role emphasizes scientific leadership in toxicological pathology, regulatory strategy...Principal- ...Consulting Principal About the Company An established and rapidly growing consulting firm serving privately held and Fortune 1000 companies Industry Management Consulting Type Privately Held About the Role The Company is seeking a Consulting Principal...Principal
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Principal Medical Writer. Be the first to apply!
- medical office front desk Blue Bell, PA
- medical Blue Bell, PA
- work from home medical data entry Blue Bell, PA
- medical authorization Blue Bell, PA
- night medical Blue Bell, PA
- pre medical Blue Bell, PA
- medical equipment Blue Bell, PA
- medical group Blue Bell, PA
- hybrid medical Blue Bell, PA
- medical review nurse remote Blue Bell, PA

