5 Contract Medical Writer 12 Month Contract Ireland jobs in Ireland
Contract Medical Writer- 12 month contract-Ireland
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Contract Medical Writer- 12 month contract-Ireland
Contract Medical Writer- 12 month contract-IrelandFor 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.
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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.
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