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Remote Regulatory Writing Jobs in Indiana (NOW HIRING)

Briljent

Clinical Auditor - RN

Indianapolis, IN · Remote

The ideal candidate brings clinical knowledge, regulatory awareness, and strong analytical and writing skills. This is a remote position with occasional travel required within Indiana. Key ...

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Remote Regulatory Writing information

What are the key skills and qualifications needed to thrive as a Remote Regulatory Writer, and why are they important?

To thrive as a Remote Regulatory Writer, you need strong scientific or medical writing expertise, attention to detail, and a background in life sciences or a related field, often supported by advanced degrees. Familiarity with regulatory submission platforms, document management systems, and guidelines such as ICH, FDA, and EMA requirements is essential. Excellent communication, time management, and the ability to work independently are crucial soft skills that set top performers apart. These competencies ensure accurate, compliant, and timely regulatory documentation crucial for product approvals and patient safety.

What is the difference between Remote Regulatory Writing vs Remote Medical Writing?

AspectRemote Regulatory WritingRemote Medical Writing
Required CredentialsLife sciences degree, regulatory affairs certifications (e.g., RAPS), scientific backgroundLife sciences or healthcare degree, medical or scientific background, writing experience
Work EnvironmentPharmaceutical/biotech companies, CROs, regulatory consulting firmsPharmaceutical, biotech, medical communications agencies, healthcare organizations
Industry UsageRegulatory submissions, INDs, NDAs, safety reportsClinical study reports, medical education materials, journal articles
Search & Comparison IntentOften compared for regulatory document creation rolesCompared for medical communication and scientific writing roles

Remote Regulatory Writing focuses on preparing documents for regulatory submissions and compliance, requiring regulatory knowledge and certifications. Remote Medical Writing involves creating scientific and medical content for various audiences, emphasizing medical knowledge and writing skills. While both roles involve scientific writing, their primary focus and industry applications differ.

What is remote regulatory writing?

Remote regulatory writing involves preparing and reviewing documents required for regulatory submissions to agencies like the FDA or EMA, such as clinical study reports, protocols, and investigator brochures. Regulatory writers ensure that all documents comply with industry standards and legal requirements, and they often work for pharmaceutical, biotech, or medical device companies. The 'remote' aspect means that professionals perform these tasks from home or another off-site location, using digital tools to collaborate with teams. This role requires strong scientific knowledge, attention to detail, and excellent written communication skills.

How do remote regulatory writers effectively collaborate with cross-functional teams while working from different locations?

Remote regulatory writers often collaborate with clinical, medical, and regulatory affairs teams spread across various regions. Effective communication is facilitated through regular video conferences, shared document platforms, and project management tools. While time zone differences can be a challenge, clear timelines and well-documented feedback processes help ensure everyone stays aligned. Building strong virtual relationships and being proactive in updates are key to maintaining seamless collaboration and delivering high-quality regulatory documents.
What are popular job titles related to Remote Regulatory Writing jobs in Indiana? For Remote Regulatory Writing jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Remote Regulatory Writing jobs in Indiana look for? The top searched job categories for Remote Regulatory Writing jobs in Indiana are:
What cities in Indiana are hiring for Remote Regulatory Writing jobs? Cities in Indiana with the most Remote Regulatory Writing job openings:
Remote Regulatory Writing jobs near you
Senior Data Analyst/Programmer - Remote

Senior Data Analyst/Programmer - Remote

Beacon Health System

Granger, IN • On-site, Remote

$77K - $97K/yr

Full-time

Posted 20 days ago

Beacon Health System rating

6.6

Company rating: 6.6 out of 10

Based on 137 frontline employees who took The Breakroom Quiz

556th of 872 rated healthcare providers

Job description

Perform technical analysis, design and project management for small projects to deliver maintainable, functional, efficient programs, general consulting and serves as a liaison with all Beacon Health System end-user departments as required. Required advanced CCL and DA2 experience within the last two years. Leads development of solutions requiring analysis and research. Leads support of existing computer applications/systems, which includes troubleshooting, conducting quality assurance and maintaining computer system security. Ability to handle the most complex issues.
Approved remote hiring states:
Indiana, Michigan, Illinois, Kansas, Ohio, Georgia, Kentucky, Florida, Idaho, Minnesota, Tennessee, Wisconsin, Colorado, South Carolina, North Carolina, Texas
MISSION, VALUES and SERVICE GOALS
  • MISSION: We deliver outstanding care, inspire health, and connect with heart.
  • VALUES: Trust. Respect. Integrity. Compassion.
  • SERVICE GOALS: Personally connect. Keep everyone informed. Be on their team.

Job Responsibility
Coordinates responsibilities and projects for defined support areas for computer applications, including project tasks, troubleshooting and documenting problems, and conveying information to the appropriate vendor(s) and/or appropriate Beacon technical staff:
  • Create maintain Cerner data extracts.
  • Prior experience with inpatient regulatory external reporting.
  • Develops and maintains documentation according to established departmental policies and procedures.
  • Analyzes complex situations or data by reviewing identifiable factors.
  • Communicates verbally (by phone and in person), in writing and visually observing keyboard and printed representations of issues or requests.
  • Actively performs troubleshooting activities to avoid potential problems.
  • Follows established standards, methodologies and procedures to ensure quality work product is produced.
  • Acts as a liaison advocating for the end-user enterprise goals. Facilitates the flow of information between end-user and information systems departments
  • Participates in system tests and analyzing test results.
  • Analyzes complex situations or data by reviewing identifiable factors.
  • Facilitates the flow of information between end-user and information systems departments.
  • Facilitates business process redesign and documentation.

Responsible for the technical analysis and design needed to ensure functionality and efficiency:
  • Works with the Systems Analysts to determine feasibility of moderately complex programming requests.
  • Completes the analysis required to determine the most efficient program designs, algorithms, file access techniques, and output formats needed to create efficient and effective software solutions.
  • Writes or contributes to instructions or manuals for data governance.
  • Confirms project requirements by reviewing program objective, input data, and output requirements with analyst and end-users.
  • Actively performs troubleshooting activities to avoid potential problems.

Provides leadership to department and customers:
  • Recognizes their influence and uses it to positively affect the performance of the work group.
  • Provides coaching and mentoring to programmers on complex code and programs.
  • Leads by example.
  • Undertaking special projects at the direction of an IS Manager, Director or the CIO.
  • Provides differentiated value to customers and peers. Must have support and respect of peers, leadership and customers before being promoted to this level.

Performs other functions to maintain personal competence and contribute to the overall effectiveness of the department by:
  • Resolves most customer satisfaction issues in a mutually agreeable way in a courteous, responsive and helpful manner. Refers only the most serious or complex issues to management.
  • Establishes and maintains effective working relationships with end-user departments.
  • Completes other job-related duties and special projects as directed.

ORGANIZATIONAL RESPONSIBILITIES
Associate complies with the following organizational requirements:
  • Attends and participates in department meetings and is accountable for all information shared.
  • Completes mandatory education, annual competencies and department specific education within established timeframes.
  • Completes annual employee health requirements within established timeframes.
  • Maintains license/certification, registration in good standing throughout fiscal year.
  • Direct patient care providers are required to maintain current BCLS (CPR) and other certifications as required by position/department.
  • Consistently utilizes appropriate universal precautions, protective equipment, and ergonomic techniques to protect patient and self.
  • Adheres to regulatory agency requirements, survey process and compliance.
  • Complies with established organization and department policies.
  • Available to work overtime in addition to working additional or other shifts and schedules when required.

Job Qualifications
Education and Experience
  • Required advanced CCL and DA2 experience within the last two years.
  • The knowledge, skills and abilities as indicated below are normally acquired through the successful completion of a bachelor's degree from an accredited college or university in Computer Science, IS, another appropriate field or equivalent experience. A minimum of three to five years of progressively more responsible experience in programming, and clinical/business acquiring knowledge of standard IT clinical/business practices for defined support areas. Preference will be given to candidates with training and experience with those software and hardware products regularly used by Beacon. Beacon programs Oracle Cerner, CCL, DA2, SVN, data extracts for external payers, specialist with Regulatory reporting.

Knowledge & Skills
  • Proficient with Oracle Cerner, CCL, DA2, SVN, data extracts for external payers, specialist with Regulatory reporting required.
  • Demonstrates knowledge of moderately complex computer operations and strong familiarity with standard concepts, practices and procedures within a particular field.

Working Conditions
  • Works in an office environment.
  • Must be effective in a fast-paced, quality focused, multi-priority environment requiring the ability to prioritize workload to meet deadlines.
  • May experience some mental/visual fatigue due to continued use of computer equipment.

Physical Demands
Requires the physical ability and stamina (i.e., to sit, stand and/or walk for prolonged periods of time, lift, hold and carry objects weighing up to 30 pounds, etc.) to perform the essential functions of the position.

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