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Remote Regulatory Writing Jobs in Michigan (NOW HIRING)

FedEx

Sr Regulatory Advisor

Romulus, MI · Remote

$4.9K - $9.4K/wk

Excellent communication skills, verbal and written. Organizational and problem solving skills ... This role is REMOTE **Candidates MUST reside within a 50 mile radius of one of the following ...

FedEx Logistics

Sr Regulatory Advisor

Romulus, MI · Remote

$4.9K - $9.4K/wk

Excellent communication skills, verbal and written. Organizational and problem solving skills ... This role is REMOTE **Candidates MUST reside within a 50 mile radius of one of the following ...

Orthos Inc

Remote Medical Biller

Niles, MI · Remote

$16.50 - $21.25/hr

... written and verbal communication skills • Ability to work independently while maintaining ... regulations • Dependable attendance, responsiveness, and follow-through on assigned ...

Stryker

Senior Manager - EHS (Remote)

Portage, MI · Remote

$153K - $255K/yr

... assessments and writing policy. What You Will Do: * Ensure compliance with all local and ... Skilled in interpreting regulatory requirements and influencing decision-making across a complex ...

Stryker

Senior Manager - EHS (Remote)

Portage, MI · On-site +1

$153K - $255K/yr

... assessments and writing policy. What You Will Do: * Ensure compliance with all local and ... Skilled in interpreting regulatory requirements and influencing decision-making across a complex ...

SalvoHealth

Medical Assistant, Remote

Detroit, MI · Remote

$18 - $22/hr

Ensure compliance with HIPAA regulations and maintain patient confidentiality * Provide general ... Excellent communication and interpersonal skills, both written and verbal * Strong organizational ...

Stryker

Senior Manager - EHS (Remote)

Kalamazoo, MI · Remote

$153K - $255K/yr

... assessments and writing policy. What You Will Do: * Ensure compliance with all local and ... Skilled in interpreting regulatory requirements and influencing decision-making across a complex ...

SalvoHealth

Medical Assistant, Remote

Detroit, MI · On-site +1

$18 - $22/hr

Ensure compliance with HIPAA regulations and maintain patient confidentiality * Provide general ... Excellent communication and interpersonal skills, both written and verbal * Strong organizational ...

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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 Michigan? For Remote Regulatory Writing jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Remote Regulatory Writing jobs in Michigan look for? The top searched job categories for Remote Regulatory Writing jobs in Michigan are:
What cities in Michigan are hiring for Remote Regulatory Writing jobs? Cities in Michigan with the most Remote Regulatory Writing job openings:
Remote Regulatory Writing jobs near you
Senior Medical Writer (Remote)

Senior Medical Writer (Remote)

MMS Holdings Inc.

Canton, MI • On-site, Remote

Full-time

Posted 8 days ago

Job description

About MMS
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions - rooted in strong science and decades of regulatory experience - that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
Responsibilities
  • Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
  • Write and edit clinical development documents, including but not limited to, clinical protocols, investigator's brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
  • Complete writing assignments in a timely manner
  • Maintain timelines and workflow of writing assignments
  • Practice good internal and external customer service
  • Highly proficient with styles of writing for various regulatory documents
  • Expert proficiency with client templates & style guides
  • Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
  • Contribute substantially to, or manages, production of interpretive guides
  • Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
  • Mentor medical writers and other members of the project team who are involved in the writing process
Requirements
  • At least 3 years of previous experience in the pharmaceutical industry
  • Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
  • The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
  • Substantial clinical study protocol experience, as lead author, required
  • Experience leading and managing teams while authoring regulatory documents with aggressive timelines
  • Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
  • Understanding of clinical data
  • Exceptional writing skills are a must
  • Excellent organizational skills and the ability to multi-task are essential prerequisites
  • Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
  • Experience being a project lead, or managing a project team
  • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
  • Not required, but experience with orphan drug designations and PSP/PIPs a plus

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