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Skills: Medical Writing, Clinical Study Reports, Regulatory Submissions, Clinical Trial Data Analysis, ICH-GCP
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Full-time
postgraduate degree
Competitive Base Salary, Performance Related Incentives, Medical Coverage, Dental Coverage, Vision Coverage, Retirement And Pension Plans
Posted 6d ago
~40 hrs/week
Remote in New Zealand, Auckland, Auckland, New Zealand
Responsibilities
Lead the development of clinical study documents and regulatory submissions while collaborating with cross-functional teams to analyze trial data. Provide strategic input for clinical development programs and mentor junior medical writers to ensure high-quality scientific output.
Requirements
Requires an advanced degree in Life Sciences, Pharmacy, or Medicine (PhD preferred) with 3-5 years of medical writing experience in the pharma or CRO industry. Must possess strong knowledge of ICH-GCP, FDA, and EMA regulatory requirements and the ability to communicate complex scientific concepts.
Full job description
Senior Medical Writer, based in New Zealand
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Role: Senior Medical Writer
Location: Home-based in New Zealand
As a global provider of drug development solutions, our work is serious business. But that doesn’t mean you can’t have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?
We are looking for conscientious, resilient, and inspiring individuals to join our team. As a Senior Medical Writer (SMW), your primary responsibility will be to provide scientific and medical/clinical writing support as part of a dedicated team servicing an assigned client. While the ability to work independently is key, the SMW will work closely with the Scientific Manager (ie, Scientific Director) and other members of the client account team to help ensure the timely delivery of high-quality and scientifically/medically accurate assigned projects. As a Senior Medical Writer, your review of junior writers’ work will also be a key part of this role. Your participation in internal company initiatives, as required, offers additional potential opportunities for growth.
The Role
As a Senior Medical Writer (SMW), prior in-depth experience with background researching, developing, and writing for the diverse array of deliverables within medical publications and medical communications is expected and will be an integral foundation for this role. The SMW role will fall broadly across the following approximate allocations (individual client account teams may have, from time to time, specific needs that may alter these allocations as may be necessary/required).
The vast majority of your time will be devoted to content development and writing, from inception to delivery, including but not limited to:
responsibility for the accurate interpretation of clinical data (e.g., from clinical study reports, safety summaries, biostatistical tables, published articles, etc), and its accurate, concise adaptation to meet assigned projects’ stated objectives
all compliance requirements for medical publications and medical communications, as relevant and appropriate (e.g., authorship guidelines, journal requirements, client confidential materials, etc)
representing assigned work at internal and external (client) meetings as required (e.g., project status, author interactions, client publication committee meetings, etc)
understanding and contributing to client publication and communication plans as required (e.g., impact on project timelines, appropriate congress and journal venues for assigned client/therapy area, relevance to client drug development planning, etc)
Some of your time will provide an opportunity to assist in the management of medical writing resources, including but not limited to, responsibility for:
monitoring and helping to manage the medical writing workload, including for junior/other writers, as required
collaboration with the Scientific Manager (ie, Scientific Director) and account managers to help ensure adherence to agreed-upon timelines (e.g., project status reports, proactive flagging of problems, resource limitations/availability, etc)
assisting in the onboarding and mentoring of new and junior medical writers, as required
There may be on occasion opportunity to assist the SM (SD) and/or GMC Senior Leadership in business development activities such as background research and writing support for new business proposals
What you need
Advanced degree, preferably PhD but PharmD and MD may also be considered
Prior relevant experience in a medical publications/medical communications agency preferred
Minimum of 3-5 years’ experience of high-level content development; applicants with 1-2 years’ experience as a Senior Medical Writer while at a medical communications agency preferred
Proven history of relevant high-level writing support, including: proficiency with ICMJE and GPP guidelines; ability to read, analyze, and interpret scientific and technical journal content; ability to develop and write to prescribed styles and formats
Ability to work efficiently with network directories/databases
Familiarity and ability to work with industry standard resources (e.g., PubMed/Medline, clinicaltrials.gov, various market intelligence/data analytic providers, etc)
Ability to work with cross-functional teams (e.g., editorial/library services, graphics/digital services, presentations support, etc)
Proficiency with commonly used software including but not limited to word processing (e.g., MS Word), graphics (e.g., PowerPoint or Prism), and bibliographic software (e.g., EndNote), and adaptability to other applicable software as may be required from time to time
Experience in resource organizing and mentoring strongly preferred
Must have demonstrable command of the English language (read, write and speak)
A strong desire to be a key part of a global network of services that lead to better outcomes for its clients, its people and for patients…apply now and Own IT@ICON !
#LI-JS1
#LI-Remote
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON 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 incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON 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.
Are you a current ICON Employee? Please click here to apply
Related keywords
Medical WritingClinical ResearchCROPharmaceuticalsBiotechnologyICH-GCPFDAEMAClinical Study ReportsCSRInvestigator BrochuresIBClinical Study ProtocolsRegulatory AffairsBiostatisticsMedical Affairs
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
Medical DeviceTherapeuticsGovernment and Public Health SolutionsClinical Research ServicesCommercialisation and OutcomesOncologyValue Based HealthcareClinical TrialsPatient RecruitmentInnovation
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