New · posted Nov 13
ICON · Pharmaceuticals
RWE Senior Medical Writer
- Remote, US
- Remote
- Full-time
- Senior & Principal
The role
- Responsible for writing and reviewing study documents such as Protocol, Synopsis, Informed Consent, Data Collection Documents and Study Report, etc.
- Responsible for developing scientific communication such as abstract, poster, manuscript, etc.
- Responsible for performing quality control for medical writing deliverables
- Responsible for interpreting statistical results and for soliciting statistician input for developing study reports, abstracts, manuscripts, and other documents as required
- Participating in the improvement of the quality assurance system
- Responsible for participating in bid-defence presentations representing medical writing activities
Senior Medical Writer - Remote
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.
At ICON, it’s our people that set us apart.
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, your primary responsibility will be to provide scientific and medical/clinical writing support as part of a team dedicated to late-phase projects, servicing an assigned client. While the ability to work independently is key, the Senior Medical Writer will work closely with the ICON team and other members of the client account team to help ensure the timely delivery of high-quality and scientifically/medically accurate assigned projects.
This writer will work with Peri- and Post - Approval Safety studies and RWE studies
What you need
- Advanced degree in a scientific discipline, PharmD
- 5+ years of professional experience in Medical Writing at a pharmaceutical, biotechnology, CRO or other health care setting
- Proven knowledge of ICH/GCP and GPP guidelines or other meaningful guidelines or industry standard
- Outstanding written and verbal interpersonal skills
- Good computer literacy
- Ability to work effectively and cooperatively with cross-functional teams
- 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!
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
What you need
Pay and benefits
ICON didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Rewards & Benefits
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
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Equal opportunity, accessibility and legal noticesICON's statements, word for word
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
Job intelligence
The context around this role
Live data · November 13, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US14 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $125,875 | $139,500 | $168,125 |
Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, November 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Evaluation & Medical Writing
The general path across 41 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not ICON's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs6
- Collaboration and leadership5
- Clinical trial conduct3
- GMP and compliance1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Evaluation & Medical Writing work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- CDISCCDISC standards(official source, opens in a new tab)SDTM, ADaM and CDASH, the clinical data standards FDA and PMDA require
Company hiring pulse
ICON on Regulatory Jobs
- 168
- Open roles
- 168
- Distinct roles
- 39
- Locations
By discipline
- Clinical162 92%
- Quality11 6%
- Regulatory4 2%
By level
- Associate & Specialist77 44%
- Senior & Principal70 40%
- Manager23 13%
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RWE Senior Medical Writer at ICON
Open until filled.