Principal Medical Writer The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The ...
Principal Medical Writer The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The ...
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... Mentor medical writers and other members of the project team who are involved in the writing ...
Quick apply
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... Mentor medical writers and other members of the project team who are involved in the writing ...
Clinical Development Lead
Indianapolis, IN · On-site +1
$100K - $186K/yr
Preferred * 3+ years of specialized experience in regulatory/medical writing specifically for In-Vitro Diagnostics (IVD), companion diagnostics, or medical devices. * Demonstrated experience with IVD ...
Clinical Development Lead
Indianapolis, IN · On-site +1
$100K - $186K/yr
Preferred * 3+ years of specialized experience in regulatory/medical writing specifically for In-Vitro Diagnostics (IVD), companion diagnostics, or medical devices. * Demonstrated experience with IVD ...
Senior Technical Writer at Theoris Indianapolis, IN
Indianapolis, IN · On-site
$90 - $135/hr
Minimum of 5 years of experience in technical, regulatory, or medical writing within a regulated industry (pharmaceuticals preferred). * Strong experience writing, editing, and maintaining SOPs ...
Senior Technical Writer at Theoris Indianapolis, IN
Indianapolis, IN · On-site
$90 - $135/hr
Minimum of 5 years of experience in technical, regulatory, or medical writing within a regulated industry (pharmaceuticals preferred). * Strong experience writing, editing, and maintaining SOPs ...
Regulatory Affairs Specialist
Warsaw, IN · On-site
This position requires an intermediate understanding of medical devices and their use as well as an ... Writes and manages the development of package inserts * Reviews and evaluations promotion and ...
Regulatory Affairs Specialist
Warsaw, IN · On-site
This position requires an intermediate understanding of medical devices and their use as well as an ... Writes and manages the development of package inserts * Reviews and evaluations promotion and ...
This position requires an intermediate understanding of medical devices and their use as well as an ... Writes and manages the development of package inserts Reviews and evaluations promotion and ...
This position requires an intermediate understanding of medical devices and their use as well as an ... Writes and manages the development of package inserts Reviews and evaluations promotion and ...
Regulatory Affairs Specialist
Warsaw, IN · On-site
$70 - $90/hr
This position requires an intermediate understanding of medical devices and their use as well as an ... Writes and manages the development of package inserts * Reviews and evaluations promotion and ...
New
Regulatory Affairs Specialist
Warsaw, IN · On-site
$70 - $90/hr
This position requires an intermediate understanding of medical devices and their use as well as an ... Writes and manages the development of package inserts * Reviews and evaluations promotion and ...
New
Regulatory Affairs Specialist
$50 - $55/hr
Regulatory Affairs Specialist The Regulatory Affairs Specialist assists the regulatory team with ... Write and manage the development, review, and maintenance of package inserts for medical devices.
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Regulatory Affairs Specialist
$50 - $55/hr
Regulatory Affairs Specialist The Regulatory Affairs Specialist assists the regulatory team with ... Write and manage the development, review, and maintenance of package inserts for medical devices.
Regulatory Affairs Specialist
Warsaw, IN · On-site
$50 - $52/hr
This position requires an intermediate understanding of medical devices and their use as well as an ... Writes and manages the development of package inserts * Reviews and evaluations promotion and ...
Regulatory Affairs Specialist
Warsaw, IN · On-site
$50 - $52/hr
This position requires an intermediate understanding of medical devices and their use as well as an ... Writes and manages the development of package inserts * Reviews and evaluations promotion and ...
Regulatory Affairs Specialist
Warsaw, IN · On-site
$48 - $52/hr
This position requires an intermediate understanding of medical devices and their use as well as an ... Writes and manages the development of package inserts * Reviews and evaluations promotion and ...
Regulatory Affairs Specialist
Warsaw, IN · On-site
$48 - $52/hr
This position requires an intermediate understanding of medical devices and their use as well as an ... Writes and manages the development of package inserts * Reviews and evaluations promotion and ...
Regulatory Affairs Specialist
Warsaw, IN · On-site
... technical writing and editing skills, verbal and written communication skills including ... Minimum of 2 years' experience in regulatory of medical devices is preferred. LANGUAGE SKILLS:
Regulatory Affairs Specialist
Warsaw, IN · On-site
... technical writing and editing skills, verbal and written communication skills including ... Minimum of 2 years' experience in regulatory of medical devices is preferred. LANGUAGE SKILLS:
Regulatory Affairs Specialist
Warsaw, IN · On-site
$45 - $52/hr
Writes and manages the development of package inserts * Reviews and evaluations promotion and ... Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and ...
Regulatory Affairs Specialist
Warsaw, IN · On-site
$45 - $52/hr
Writes and manages the development of package inserts * Reviews and evaluations promotion and ... Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and ...
Deviation Writer
Bloomington, IN · On-site
... Medical Device, and Life Sciences industries. I am actively connecting with professionals for ... Maintain compliance with GMP regulations, internal procedures, and quality standards. * Simplify ...
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Deviation Writer
Bloomington, IN · On-site
... Medical Device, and Life Sciences industries. I am actively connecting with professionals for ... Maintain compliance with GMP regulations, internal procedures, and quality standards. * Simplify ...
Regulatory Affairs Manager
Indianapolis, IN · On-site
$48 - $53/hr
Strong verbal and written communication skills. * Excellent communication and presentation skills ... Medical, Dental, and Vision Insurance * 401(k) Retirement Plan * Health Savings Account (HSA)
New
Regulatory Affairs Manager
Indianapolis, IN · On-site
$48 - $53/hr
Strong verbal and written communication skills. * Excellent communication and presentation skills ... Medical, Dental, and Vision Insurance * 401(k) Retirement Plan * Health Savings Account (HSA)
New
Regulatory Affairs Manager
Indianapolis, IN · On-site
$48 - $53/hr
Strong verbal and written communication skills. * Excellent communication and presentation skills ... Medical, Dental, and Vision Insurance * 401(k) Retirement Plan * Health Savings Account (HSA)
New
Quick apply
Regulatory Affairs Manager
Indianapolis, IN · On-site
$48 - $53/hr
Strong verbal and written communication skills. * Excellent communication and presentation skills ... Medical, Dental, and Vision Insurance * 401(k) Retirement Plan * Health Savings Account (HSA)
New
Regulatory Coordinator | On-site, Indianapolis, IN
Indianapolis, IN · On-site
$60K - $70K/yr
Driven by our commitment to supply high-quality medical devices, our team works to deliver best in ... Must be able to speak, read and write English. * Understanding and experience with US FDA, and ISO ...
Quick apply
Regulatory Coordinator | On-site, Indianapolis, IN
Indianapolis, IN · On-site
$60K - $70K/yr
Driven by our commitment to supply high-quality medical devices, our team works to deliver best in ... Must be able to speak, read and write English. * Understanding and experience with US FDA, and ISO ...
Regulatory Compliance Specialist II
Fishers, IN · On-site
$70 - $90/hr
Perform compliance reviews for regulatory compliance and provide written documentation of outcomes ... Medical, dental, and vision insurance for full‑time employees - eligibility begins on day one ...
Regulatory Compliance Specialist II
Fishers, IN · On-site
$70 - $90/hr
Perform compliance reviews for regulatory compliance and provide written documentation of outcomes ... Medical, dental, and vision insurance for full‑time employees - eligibility begins on day one ...
Effective written and verbal communication skills. Preferred: * Experience in medical devices, healthcare, or other highly regulated industries. * Familiarity with U.S. regulatory and technical ...
Effective written and verbal communication skills. Preferred: * Experience in medical devices, healthcare, or other highly regulated industries. * Familiarity with U.S. regulatory and technical ...
Technical Writer at Medasource Lebanon, IN
Lebanon, IN · On-site
$65 - $85/hr
Ensure all documentation meets company standards, regulatory expectations, and industry guidelines ... Prior experience as a Technical Writer in pharma, biotech, medical device, or another regulated ...
New
Technical Writer at Medasource Lebanon, IN
Lebanon, IN · On-site
$65 - $85/hr
Ensure all documentation meets company standards, regulatory expectations, and industry guidelines ... Prior experience as a Technical Writer in pharma, biotech, medical device, or another regulated ...
New
Regulatory Affairs Project Manager
Indianapolis, IN · On-site
$84K - $157K/yr
... write and prepare submission packets for health authority marketing approvals, and utilize agile ... You have experience in Healthcare Regulatory Affairs for IVD/Medical Device preferred. * You can ...
Regulatory Affairs Project Manager
Indianapolis, IN · On-site
$84K - $157K/yr
... write and prepare submission packets for health authority marketing approvals, and utilize agile ... You have experience in Healthcare Regulatory Affairs for IVD/Medical Device preferred. * You can ...
Regulatory Medical Writer information
See Indiana salary details
$13.50 - $17.28
3% of jobs
$17.28 - $21.06
9% of jobs
$24.77 is the 25th percentile. Wages below this are outliers.
$21.06 - $24.85
13% of jobs
$24.85 - $28.63
7% of jobs
$28.63 - $32.42
8% of jobs
$32.42 - $36.20
5% of jobs
The median wage is $37.86 / hr.
$36.20 - $39.99
8% of jobs
$39.99 - $43.77
16% of jobs
$45.23 is the 75th percentile. Wages above this are outliers.
$43.77 - $47.56
12% of jobs
$47.56 - $51.34
7% of jobs
$51.34 - $55.13
11% of jobs
$13
$36
$55
How much do regulatory medical writer jobs pay per hour?
What is a regulatory medical writer?
A Regulatory Medical Writer prepares clinical and regulatory documents required for drug development and approval processes. They collaborate with scientists, clinicians, and regulatory teams to create clear, accurate, and compliant documents such as clinical study reports, investigator brochures, and regulatory submissions. Their work ensures that complex scientific data is communicated effectively to regulatory agencies like the FDA or EMA. Strong writing, analytical, and compliance knowledge are essential for this role.
What are the key skills and qualifications needed to thrive as a regulatory medical writer?
To thrive as a Regulatory Medical Writer, you need strong scientific knowledge, excellent written communication skills, and a degree in life sciences or a related field. Proficiency with regulatory documentation formats (such as CTD/eCTD), familiarity with guidelines like ICH, and experience using document management systems are often required. Meticulous attention to detail, organizational skills, and the ability to collaborate effectively with cross-functional teams are valuable soft skills. These qualifications are crucial to ensure the accurate, compliant, and timely preparation of regulatory submissions supporting drug approvals and clinical research.
What are some typical challenges faced by regulatory medical writers in their daily work?
Regulatory Medical Writers often face tight deadlines and shifting project priorities, especially when coordinating documents needed for regulatory submissions. They must interpret complex scientific data and adhere strictly to changing regulatory guidelines, which can be demanding. Navigating feedback from multiple stakeholders—such as clinical, regulatory, and statistical teams—requires strong communication and negotiation skills. Staying organized and proactively managing timelines are essential for success in this fast-paced, detail-oriented role.
How much money can you make as a regulatory medical writer?
Is there a demand for regulatory medical writers?
What are the most commonly searched types of Regulatory Medical Writer jobs in Indiana?
The most popular types of Regulatory Medical Writer jobs in Indiana are:
What are popular job titles related to Regulatory Medical Writer jobs in Indiana?
For Regulatory Medical Writer jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Regulatory Medical Writer jobs in Indiana look for?
The top searched job categories for Regulatory Medical Writer jobs in Indiana are:

Job description
Job Description:
Principal Medical Writer
The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards. The Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.
Make an Impact at Veristat!
Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.
105+ approved therapies for marketing applications prepared by Veristat
480+ oncology projects in the past 5 years
350+ rare disease projects delivered in the past 5 years
Flexible, inclusive culture - 70% remote workforce, 66% women-led teams
Learn more about our core values here!
What we offer:
Benefits vary by location and may include:
o Remote working
o Flexible time off
o Paid holidays
o Medical insurance
o Tuition reimbursement
o Retirement plans
What we look for:
Bachelor's degree required; science-related field preferred.
Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.
Advanced knowledge of ICH and related regulatory guidelines.
Excellent written English and keen attention to detail.
Strong interpersonal and communication skills.
Experience with Microsoft Office Suite is essential, including advanced Microsoft Word proficiency.
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
About Veristat
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Southborough, MA, US
Year founded
1994