Senior Medical Writer

1 month ago


Ireland Premier Consulting Group, Inc. Full time

Premier Consulting, a division of Premier Research, is seeking a  Senior Medical Writer . Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process.

What you’ll be doing:

  • Independently write and format clinical and regulatory documents
  • Review and approve clinical and regulatory documents including, but not limited to: synopses and protocols, clinical study reports, in-text tables, appendices, addendums, study plan outlines, and documents for regulatory submissions (e.g., Investigational New Drug applications, sections of marketing applications, investigator brochures, or other clinical and regulatory documents)
  • Ensure timeline adherence for each assigned project, provide project status updates on a regular basis and carry out contractual obligations for each assigned project
  • Work on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and clients
  • Interpret and summarize clinical data as needed to prepare documents
  • Review all source documents, perform literature searches, and interact with internal team members and external clients to develop a thorough understanding of project background, timelines, and goals
  • Advise clients on appropriate document preparation and the basic regulatory requirements of various types of documents

What we’re searching for:

  • Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred
  • BA/BS and 6-10 years of experience in medical/regulatory writing; or MS and 4-6 years of experience in medical/regulatory writing; or PhD and 2+ years of experience in medical/regulatory writing
  • Strong knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
  • Superior working knowledge of software programs in Windows environment with excellent proficiency in word processing, flow diagrams, and spreadsheets
  • Ability to learn fast, to convert relevant scientific data/information into high quality summaries and reports

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly
care about one another, about our clients, and about our mission of furthering
research to improve the lives of patients in critical need.

• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.

• Our dedication to biotech and specialty pharma is unlike any other. We provide our
staff with innovative technologies and continuous learning opportunities so that they
have the tools they need to be successful.


Because we are transforming life-changing ideas into new medical treatments for a diverse
population, we require the perspectives of a diverse staff thinking creatively, challenging ideas,
and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion,
and empowerment, we create a community of belonging that welcomes differences, fuels
innovation, and better connects us to the patients, physicians, and customers we serve.


We hire people that add to our culture, then invest in developing skills and abilities. If you are
excited about this role, but your past experiences do not perfectly align with the position as
described, we encourage you to apply anyway. You may be exactly the right candidate for this
role or others.

#J-18808-Ljbffr
  • Senior R&D Engineer

    4 weeks ago


    Ireland X-BOLT Orthapaedics Full time

    We are seeking an experienced Senior R&D Engineer with a passion for the technical challenges faced in developing orthopaedic medical devices and a deep understanding of the interoperative challenges faced by our customers. KEY AREAS OF RESPONSIBILITY • Lead new product introduction projects and associated R&D • Lead design control activities,...

  • Senior R&D Engineer

    4 days ago


    Ireland Veryanmed Full time

    Senior R&D Engineer Full time - Permanent Galway- Hybrid We have an exciting opportunity for a  Senior R&D Engineer to join Veryan Medical! Summary Veryan Medical is a fast-paced, rapidly growing medical device company offering a highly differentiated solution in SFA interventions. We share a commitment, a passion, and a vision for the contribution...


  • Ireland Pale Blue Dot Recruitment Full time

    Galway , Connaught , Ireland Software / Hardware Our client, an exciting medical device start-up, based in Galway is hiring a Senior Electronic Engineer. The successful candidatewill provide technical supportto the product development team, liaising with external partners in the development of a novel medical technology. Responsibilities include but are...

  • CSV Consultant

    4 weeks ago


    Ireland NNIT AS Full time

    Provide Computerized System Validation (CSV) / Computerized System Assurance (CSA) consulting services for pharmaceutical and medical device Manufacturing company. Manage SDLC (system design life cycle) including risk, deviation and change managements (e.g., conduct risk impact or functional assessment(s)) Ensure Good Documentation Practices, working with...


  • Ireland Stryker Group Full time

    Why engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker,you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better.Here,you will work in a supportive culture withotherincredibly...

  • Senior Accountant

    5 days ago


    Ireland Chanelle Group Full time

    Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products. Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and...


  • Ireland Viatris Company Full time

    Senior Manager, Device Design and Industrialisation page is loaded Senior Manager, Device Design and Industrialisation Apply locations Little Chesterford, England, United Kingdom time type Full time posted on Posted 2 Days Ago job requisition id R5646405 Mylan Pharma UK Limited At VIATRIS, we see healthcare not as it is but as it should be. We act...


  • Ireland NIRAS Belgium Full time

    NIRAS Ireland provides Project Management, Engineering Design, and Project resourcing services to the Pharmaceutical and Life Science Sectors. As a company we specialize in the design and delivery of process-driven projects across Ireland and internationally. We are currently seeking a Project Engineer to join our client’s manufacturing based in co...


  • Ireland Kenny-Whelan & Associates Full time

    Our Cork-based Client are currently on the lookout for a Mechanical Project Engineer, on a long term rolling contract basis (this is a Client side role) Role Description This is a contract Mechanical Project Engineer role located in Cork with flexibility for some remote work. The successful candidate will be responsible for project management, project...


  • Ireland eli lilly and company Full time

    Associate / Senior Associate - Clinical Central Services & innovation page is loaded Associate / Senior Associate - Clinical Central Services & innovation Apply locations Ireland, Cork time type Full time posted on Posted Yesterday job requisition id R-63259 At Lilly, we unite caring with discovery to make life better for people around the world. We are...

  • Aquatics Manager

    4 days ago


    Ireland American Swim Academy Full time

    Are you looking to join a fun company with career growth opportunities? The American Swim Academy is hiring in the East Bay! We are looking for a dynamic career-oriented Aquatics Manager to join our senior management team in Dublin. The Aquatics Manager will be responsible for assisting Senior Management in the operation of the facility. Your duties will...

  • R&D Staff Engineer

    4 days ago


    Ireland EPM Scientific - Phaidon International Full time

    The role of Senior Staff Engineer takes on a hands-on, customer facing, technical leadership role on a cross functional project core team guiding the design, development, verification and validation of on-body combination products in support, this role will give the opportunity to develop user-centric on-body drug delivery solutions designed to drive...


  • Ireland Edwards Lifesciences Full time

    Lead the engineering team in transfer of products and supporting manufacturing operations. How Will You Make An Impact? Plan and direct complex project activities with large scale or significant business impact with the accountability for successful completion of all project deliverables to the business and develop project plans and schedule, scope, and...


  • Ireland SQA Services Full time

    If you have an eye for detail and want to help assure quality and facility qualifying and monitoring supply chain’s via audits in the animal health, pharmaceutical and similar regulated environments space, then this is the role for you! We have upcoming projects in the United Kingdom and the European Union in 2024, 2025 and beyond! We're looking for...


  • Ireland ICDS RECRUITMENT CONSULTANTS LTD Full time

    Project Management Professionals (Construction) Dublin, Cork, Galway, Limerick & Waterford Thinking of returning to work in Ireland, looking for a move to Dublin, Cork, or Galway? Construction activity across Ireland has generated several vacancies in the commercial, residential, medical, industrial, pharmaceutical, civil engineering, mechanical and...


  • Ireland ICDS (UK) Ltd Full time

    Project Management Professionals (Construction) Dublin, Cork, Galway, Limerick & Waterford Thinking of returning to work in Ireland, looking for a move to Dublin, Cork, or Galway? Construction activity across Ireland has generated several vacancies in the commercial, residential, medical, industrial, pharmaceutical, civil engineering, mechanical and...


  • Ireland Lovin- JobBoard Full time

    Established in 1995, STAXS, are a leading provider of cleanroom consumables and services for the Pharma and Life Sciences industries across Europe. They have an exceptional company ethos and offer a hugely supportive working environment with a progressive outlook on how to do business based on the following core pillars: Quality Professionality Style ...

  • Sales Representative

    4 weeks ago


    Ireland Lovin- JobBoard Full time

    Established in 1995, STAXS, are a leading provider of cleanroom consumables and services for the Pharma and Life Sciences industries across Europe. They have an exceptional company ethos and offer a hugely supportive working environment with a progressive outlook on how to do business based on the following core pillars: Quality Professionality Style ...

  • Senior CAD Engineer

    2 weeks ago


    Ireland Gordon Murray Design Full time

    Job Reference No: ID 836 Gordon Murray Technologies combines the expertise of visionary designers and engineers to bring disruptive technologies and low environmental impact innovations to the mobility sector. Critical to the implementation of iStream Superlight are integral modules and systems engineered to deliver a range of electrical functionalities...

  • CQV Consultant

    4 weeks ago


    Ireland NNIT AS Full time

    Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following areas: Process Equipment CIP / SIP Temperature Controlled Unit (TCU) Utilities (e.g., water, gas, steam) HVAC Develop URS, specifications, risk assessment, system impact assessments, protocols and...