5 Contract Medical Writer 12 Month Contract Ireland jobs in Ireland

Contract Medical Writer- 12 month contract-Ireland

County Dublin, Leinster ProPharma

Job Viewed

Tap Again To Close

Job Description

workfromhome

Contract Medical Writer- 12 month contract-Ireland

Contract Medical Writer- 12 month contract-Ireland

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.

ProPharma are looking for an experienced freelancer or temporary Medical Writer to join the team for 12 months to support a team member on maternity leave. This is a fully remote role across Ireland. The Medical Writer position is responsible for authoring regulatory writing deliverables that focus on quality, accuracy, and efficiency and for providing regulatory writing support to ProPharma clients.

Essential Functions:

  • Author (write / edit) high-quality regulatory writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) including but not limited to protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs / CERs, DSURs, and plain language summaries. May participate in authoring more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission-level documents) under the supervision of senior personnel.
  • Adhere to established regulatory standards / guidelines including but not limited to: ICH E3 / E6(R2), EU MDR / IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates.
  • Strive to complete writing deliverables on time and within budget.
  • Interact and communicate directly with clients, lead team meetings (e.g., project kickoff, comment review), and manage the deliverable timelines, with support from senior personnel (as needed).
  • Interact and collaborate as needed with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables.
  • Coordinate QC reviews of documents and maintain audit trails of changes as applicable.
  • Review statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency.
  • If requested by supervisor, perform QC review (e.g., reviews in-text tables against statistical output).
  • Assist with project-related administrative tasks (e.g., creating and maintaining timelines, updating deliverable trackers, and hosting internal/client meetings) with support from senior personnel (as needed).
  • Maintain familiarity with current industry practices, regulatory requirements, and guidelines related to regulatory writing.
  • Understand budget specifications for assigned deliverables, work within the budgeted hours, and communicate out-of-scope tasks to regulatory writing leadership.

Ideal skills and requirements:

  • Knowledge of clinical research principles and the ability to interpret and present clinical data and other complex information.
  • Understanding of global regulatory bodies and applicable regulations and guidelines.
  • Understanding of regulatory submission requirements and processes.
  • Minimum of 3 years of experience writing clinical and regulatory documents for drugs, biologics, medical devices/diagnostics for a CRO, pharmaceutical company, or biotechnology company.
  • Experience writing & editing scientific documents or experience in reviewing scientific data preferred.
  • Experience in phase I and II & pre clinical study experience is vital for this role.
#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Job No Longer Available

This position is no longer listed on WhatJobs. The employer may be reviewing applications, filled the role, or has removed the listing.

However, we have similar jobs available for you below.

Clinical Research Nurse - Cardiology (CNM2)

Dublin, Leinster Mater Private Hospital Group

Posted today

Job Viewed

Tap Again To Close

Job Description

Be a Heart Research Hero: Clinical Research Nurse (Cardiology) Join our passionate team at the forefront of cardiovascular research! As a Clinical Research Nurse (CNM2) at the Mater Private Hospital's Cardiovascular Research Institute Dublin, you'll play a pivotal role in driving advancements in heart health. Why you'll thrive here: Make a tangible difference in the lives of cardiac patients through groundbreaking research. Collaborate with a dedicated team of researchers and clinicians in a dynamic environment. Gain valuable experience in clinical research methodologies and contribute to impactful publications. Utilise your strong clinical skills and organisational talents to ensure smooth study execution. Responsibilities: Work alongside investigators to recruit participants for clinical trials in cardiology. Manage research databases and ensure accurate data collection. Coordinate patient study visits, adhering to protocols and regulations. Educate and support patients throughout the research process. You're a great fit if you have: A minimum of 5 years' experience as a Registered General Nurse with the NMBI. At least 2 years' experience in cardiology care. Proven clinical and managerial skills with a keen interest in research. Excellent interpersonal and communication abilities to build rapport with patients and colleagues. Strong organisational skills and a meticulous attention to detail. Bonus points for: Prior experience in clinical research. Postgraduate qualifications in research or cardiology. The Mater Private Network offers: Competitive salary and benefits package. Opportunities for professional development and training. A supportive and collaborative work environment. Be part of a team making a real difference in healthcare. Ready to join us? We look forward to receiving your CV! Mater Private Network is an Equal Opportunities Employer Skills: Research Nurse Manager
This advertiser has chosen not to accept applicants from your region.

Clinical Research Nurse (CNM II)- Cardiology

Dublin, Leinster €44846 - €53151 hour recruitNet

Posted 355 days ago

Job Viewed

Tap Again To Close

Job Description

Permanent
RecruitNet International Ltd   Specializing in relocating qualified professionals throughout Ireland and overseas, we guide you through the We the RecruitNet team are always on call to help you find your perfect job and are staffed by highly experienced and professional nursing recruitment consultants.  Provide clinical treatment to patients with varying degrees of heart failure as a member of a multidisciplinary team, this role will prioritize research and the provision of healthcare services.Research initiatives in cardiac therapy.Participant recruiting, database administration, and study visit coordination will all be a part of this multidisciplinary team role. RequirementsBe on the live register with NMBI.Minimum of 5 years post-registration experience. Strong interpersonal & communication skills.A minimum of two years at least after registration in a treatment field related to cardiology.Capabilities in management and leadership.BenefitsFully Funded Private Health InsuranceGenerous SalariesEducational SupportExcellent Career OpportunitiesProvide exceptional patient care in an environment where quality, respect, caring, and compassion are at the centre of all that we do.
This advertiser has chosen not to accept applicants from your region.

Clinical Nurse Manager 1 - Research Nurse

Dublin, Leinster Childrens Health Ireland

Posted 9 days ago

Job Viewed

Tap Again To Close

Job Description

Purpose of the Role Clinical research is essential to provide an evidence base for improved medicines and treatment of sick children. It is well accepted internationally that hospitals active in research and innovation are associated with better outcomes for patients and better recruitment and retention of staff. As Ireland's largest paediatric hospital and the leading centre in Ireland for the conduct of clinical trials and studies in children and young adults, CHI has placed excellence in research and innovation as one of its key strategic objectives. As part of ongoing development at CHI towards the opening of the new Children's Hospital, a rationalisation and integration of the existing clinical research infrastructure across all sites is being undertaken. Under the leadership of the CHI Director of Research & Innovation, a new Research & Innovation Office (RIO) and Clinical Research Centre (CRC) are being set-up within CHI and will bring all aspects of clinical research infrastructure together under a single governance and management structure. The Clinical Research Centre is the forerunner of the new paediatric Clinical Research Facility (CRF) that will be embedded in the new Children's Hospital. The CRC is made up of a team of research staff working across CHI sites to support clinical teams in the conduct of clinical trials and other clinical research studies that require specialist expertise and support. The Clinical Research Nurse is a key part of this team, working to support Investigators and research teams with clinical research activities. They will act as the primary advocate for the patient, both prior to and throughout their participation in a research study or clinical trial. As part of a team of Research Nurses, they will work closely with the CRC Operations Manager, Project Managers, Research Nurses and Research Coordinators, ensuring that study activities are carried out effectively and in compliance with Good Clinical Practice (GCP) standards. They will have particular focus on assisting the Principal Investigator to enrol patients to studies and clinical trials and schedule and conduct study visits, ensuring patient safety throughout and maintaining the Investigator Site File. Throughout the research study lifecycle, this role will provide continuity back-up and support as required to other Clinical Research Nurses and Coordinators to ensure the smooth running of research activities from set-up through to closeout, across the portfolio. This is an exciting opportunity to work within a highly motivated team and a dynamic environment, and to be involved in bringing advancements in health outcomes for children and young adults in Ireland. The role offers opportunities for ongoing professional development and the successful candidate will be provided with training and mentoring specific to their role. Essential Criteria: Be registered in the Children's division of the active register of Nurses & Midwives maintained by the Nursing and Midwifery Board of Ireland (Bord Altranais agus Cnimhseachais na hireann) OR Be registered in the General Division of the active register held by NMBI and have relevant children's nursing experience AND At least 3 years post registration experience or equivalent relevant experience. Have the clinical, managerial and administrative capacity to properly discharge the functions of the role Demonstrate evidence of continuing professional development at the appropriate level To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
This advertiser has chosen not to accept applicants from your region.

Principal Medical Writer EMEA (Client-embedded)

ThermoFisher Scientific

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.  
**Summarized Purpose:**  
We are excited to be expanding our Medical Writing FSP Team. We seeking a PMW dedicated to a client in the FSP space; preferred candidates will have experience in Structured Content Authoring systems and automation to support delivery. The ideal candidate will be experienced and highly skilled, responsible for creating, reviewing, and managing clinical regulatory documents. This role requires a strong understanding of scientific concepts, exceptional writing skills, and the ability to communicate complex information clearly and concisely.
Our client, a global mid-sized biotech company, focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing, international organization has a strong scientific foundation. If you're looking for a place where your work, in partnership with others, can have real impact-and where you're encouraged challenge yourself and contribute to breakthrough solutions , **the Principal Medical Writer role** could be a great fit.
**Key Responsibilities:**
+ Lead the development, writing, and editing ofcomplexclinical and regulatory documents.
+ Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to ensure theaccurateandtimelycompletion of documents.
+ Ensure documentsalignwith regulatory guidelines, company standards, and industry best practices.
+ Provide strategic input and guidance on document content, structure, and presentation.
+ Mentor and provide oversight to junior medical writers and ensure high-quality deliverables.
+ Manage multiple writing projects simultaneously and prioritize tasks effectively.
+ Stay current with industry trends, guidelines, and regulatory requirements.
**Education and Experience:**  
+ Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualificationrequired; Advanced degree preferred. 
+ Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role(comparable to 8+ years in core Regulatory Medical Writer role capacity). 
+ Experience working in the pharmaceutical/CRO industryrequired. 
+ Experience in managing and directing complex medical writing projectsrequired.
+ Extensive experience in Phase 3 CSRs and/or protocol developmentrequired.
+ EU CTR experience preferred.
+ Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generationpreferred.  
**Knowledge, Skills, and Abilities:**  
+ Excellent organizational andprogram management skills. 
+ Proven leadership skills to manage and mentor a team of medical writers.
+ Extensive knowledge ofregulatory guidelines and drug development processes.
+ Strong interpersonal and communication skills to build andmaintaineffective working relationships with colleagues and stakeholders. 
+ Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards.
+ Self-motivated and adaptable. 
+ Excellent judgment; high degree of independence in decision making and problem solving. 
+ Capable of mentoring and leading junior level staff. 
**What We Offer:**  
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme ( , ensuring you reach your potential.   
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture ( , where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.  
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. 
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.

Consultant/Medical Writer - Global Value Dossiers

Dublin, Leinster ICON Clinical Research Ltd

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

Consultant/Medical Writer - Global Value Dossiers - Ireland/UK/Spain/Portugal/Bulgaria/Poland but may consider other European countries. Home or office based ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. The Consultant/Medical Writer is responsible for the provision of services for assigned clients in their area of expertise. Job Description Conducts technical project management, including scope of work development, contract initiation, and project milestones, timelines, deliverables, and budgets Supports project lead/director on other projects as needed Identifies risks with completing specific deliverables and effectively executes strategies to minimize them Maintains understanding of project requirements and identifies scope creep as it happens. Alerts business operations and project lead/director to the need for a change order at appropriate times. Communicates efficiently and effectively across the ICON project team Communicates regularly with client's assigned point of contact regarding project tasks, budgets and timelines Establishes and maintains regular meetings with clients including drafting agendas, managing calendars, summarising notes and tracking agreed actions Completes internal documentation and quality-checks the work of others Participates in proposal and quote development Specific Focus: Evidence dossiers Assists in document and information revisions and updates for different types of evidence dossiers (i.e., Health Technology Appraisals, Global Value Dossiers, Joint Clinical Assessment dossiers) With direction, develops approach to assigned piece(s) of the client project Conducts appropriate searches of literature or guidance documents with limited direction of senior staff Assesses project relevant data, identifies issues and prepares gap assessments May be asked to oversee and guide ad hoc external contractors who have been commissioned by ICON to draft the relevant content as a member of the project team Client Development Maintains up-to-date understanding of the specific nature of key client relationships and supports the building/broadening of these relationships where appropriate Assists in formulating recommendations that help clients meet their goals by maintaining a current understanding of their commercial objectives and market access requirements Behaviours Proactively and independently expands knowledge base and remains current on developments, trends and best practices for subject matter expertise Efficiently manages own workload with respect to project scope, timelines and quality Maintains strong understanding of the pharma/biotech/medical device industry landscape as it relates to technically relevant trends and challenges Performs other duties and tasks as are allocated at the reasonable discretion of the Company Recognizes, exemplifies and adheres to ICON's values which center on our commitment to People, Clients and Performance As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs Demonstrates and actively promotes an open and honest working environment to encourage close teamwork and foster knowledge transfer General Travel (Up to 15%) domestic and/or international Education and experience Excellent communication and interpersonal skills, with the ability to effectively collaborate with multidisciplinary teams and stakeholders Experience Working in Market Access in the pharmaceutical industry (pharma company or consultancy). English professional level in speaking and writing. Direct HTA/HE experience and understanding. Education/Qualifications Bachelor's degree or equivalent. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply To be considered for this role you will be redirected to our careers page & prompted to create a jobseeker account here. To start the process, click the Continue to Application or Login/Register button below. Benefits: Work From Home
This advertiser has chosen not to accept applicants from your region.
Be The First To Know

About the latest Contract medical writer 12 month contract ireland Jobs in Ireland !

Nearby Locations

Other Jobs Near Me

Industry

  1. request_quote Accounting
  2. work Administrative
  3. eco Agriculture Forestry
  4. smart_toy AI & Emerging Technologies
  5. school Apprenticeships & Trainee
  6. apartment Architecture
  7. palette Arts & Entertainment
  8. directions_car Automotive
  9. flight_takeoff Aviation
  10. account_balance Banking & Finance
  11. local_florist Beauty & Wellness
  12. restaurant Catering
  13. volunteer_activism Charity & Voluntary
  14. science Chemical Engineering
  15. child_friendly Childcare
  16. foundation Civil Engineering
  17. clean_hands Cleaning & Sanitation
  18. diversity_3 Community & Social Care
  19. construction Construction
  20. brush Creative & Digital
  21. currency_bitcoin Crypto & Blockchain
  22. support_agent Customer Service & Helpdesk
  23. medical_services Dental
  24. medical_services Driving & Transport
  25. medical_services E Commerce & Social Media
  26. school Education & Teaching
  27. electrical_services Electrical Engineering
  28. bolt Energy
  29. local_mall Fmcg
  30. gavel Government & Non Profit
  31. emoji_events Graduate
  32. health_and_safety Healthcare
  33. beach_access Hospitality & Tourism
  34. groups Human Resources
  35. precision_manufacturing Industrial Engineering
  36. security Information Security
  37. handyman Installation & Maintenance
  38. policy Insurance
  39. code IT & Software
  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
View All Contract Medical Writer 12 Month Contract Ireland Jobs