Hire the best Pharmaceutical Industry Specialists in Michigan

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$55 hourly
Cristina D.
- 4.5/5
- (10 jobs)
OBJECTIVE Versatile and qualified Regulatory Professional with medical writing experience specializing in regulatory, pharmaceuticals, and medical devices. With experience in both pre-clinical research and regulatory affairs, producing a large volume of high-quality materials in various therapeutic areas and formats. A dedicated professional who combines project management experience and analytical skills to create, edit, and coordinate the production of submission ready documents. Experience being responsible for formatting, editing, and the completion of the necessary clinical documents. PROFESSIONAL PROFILE * Experience with writing and submitting dossiers to the necessary regulatory authorities with a strong understanding of editing concepts for accuracy and consistency. * Strong knowledge or regulatory concepts, methods, and procedures. As well as strong skills working with other regulatory professionals to ensure fast and timely approvals. * Experience with project management and coordination in multiple international markets such as Europe, China, and Canada. SUBMISSIONS AND DOCUMENTS • Developed style guides, work-practice documents, quality control checklists, and templates that help support the Client’s infrastructure needs. • Experience publishing documents per ICH eCTD specifications. o Experience with CTD Modules: 5.2, 2.7.3, 2.7.5, 2.7.6. • Achieved on-time preparation of medical device project-driven documents that support the Client’s regulatory writing needs. o Experience with the necessary document submissions for 510(k) Class I and Class II medical devices. • Experience developing and writing clinical study reports, Investigator’s Brochures, and Standard Operating Procedures (SOPs) as well as briefing documents. • Maintains a strong knowledge of different eSubmission styles and formatting standards.

Pharmaceutical Industry
Project Management
Adobe Acrobat
Interpersonal Skills
Microsoft Office
Medical Writing
Problem Solving
Regulatory Intelligence
Medical Device
Data Analysis
Regulatory Compliance
$50 hourly
Lisa K.
- 0.0/5
- (0 jobs)
I am a health, science, and education writer with a background in journalism and over 15 years of experience crafting compelling, research-based content. I specialize in translating complex topics into clear, engaging, and informative narratives for both professional and general audiences. My work has been featured in trade magazines, industry publications, and newspapers. What I Offer: * Health & Science Writing – Well-researched articles, white papers, and case studies that break down medical, scientific, and healthcare concepts for professionals and the public. * Education & EdTech Content – Thought leadership pieces, feature stories, and reports on alternative education, instructional strategies, and school leadership. * Feature Writing & Storytelling – In-depth profiles, human-interest stories, and investigative pieces for newspapers, magazines, and online publications. * Ghostwriting – Expertly crafted content that positions healthcare professionals, educators, and industry leaders as authorities in their fields. * SEO-Optimized Content – Articles and blog posts designed to increase visibility and engagement. If you're looking for a writer who can bring clarity, depth, and impact to your project, let’s connect!

Pharmaceutical Industry
Food Science
Educational Leadership
Curriculum Development
Storytelling
Biography Writing
Ghostwriting
News Article
Magazine
Editing & Proofreading
Technical Writing
Scientific Writing
Proofreading
Academic Editing
Content Writing
$140 hourly
Helen S.
- 0.0/5
- (0 jobs)
Summary Regulatory Affairs and Pharmaceutical Technical Consultant with 26 years of experience in the pharmaceutical industry, I specialize in ensuring regulatory submissions and raw data adhere to health authority requirements and cGMP compliance. My expertise spans combination products, nasel sprays, liquids & semi-solids, tablets and sterile injectables. I've conducted quality control release/stability testing, developed/evaluated manufacturing processes, prepared/ reviewed/submitted INDs CTAs, EUAs, NDAs, annual reports and post approaval changes, while ensuring adherence to ALCOA principles and regulatory standards (including 510(k) submisions).

Pharmaceutical Industry
Six Sigma
Process Improvement
Process Engineering
Team Alignment
Communication Skills
Model Validation
Regulatory Compliance
Scientific Writing
Technical Writing
$25 hourly
Merisa L.
- 0.0/5
- (0 jobs)
I am a Configuration Analyst working in the Healthcare Industry. Open to additional part time opportunities that I can apply my experience to! Summary of Qualifications * Analyze data pertinent to any appropriate system configuration changes. * Analyze and interpret state/federal benefits and contracts through system coding, updating, and maintaining benefits plans, provider contracts, fee schedules and various system tables through the user interface. * Resolution of any claim issues submitted by providers or specialists. * Conduct data analysis to aid in the development, coordination, and maintenance of the health plan's program. * Proficient in Medicare Part D, Michigan and Illinois Medicaid Prescription prior authorization clinical review and assurance that cases are adherent to CMS guidance and criteria. * PBM experience in Medicare Part D, Michigan and Illinois Medicaid, Advantage plan and HIM lines of business. Ability to navigate in various departments within PBM.

Pharmaceutical Industry
Salesforce
Microsoft SharePoint
Preauthorization
Contract
Insurance Claim Submission
Insurance
Healthcare Management
Healthcare
Pharmacology
VLOOKUP
Excel Formula
Microsoft Project
General Transcription
Data Entry
$22 hourly
Elizabeth W.
- 0.0/5
- (0 jobs)
I have several years of experience in healthcare business roles. I have extensive experience in pharmacy, I understand inpatient hospital charges, and also outpatient/retail pharmacy claims processing. I was certified as a tech which has lapsed but can do anything that does not require the certification. I have extensive experience in healthcare reimbursement, setting fees, creating fee schedules, analyzing large data sets, taking excel files and databases to create one large workfile within Microsoft Access. I am very proficient in Microsoft Excel. I can do anything type of data entry or administrative tasks.

Pharmaceutical Industry
EMR Data Entry
Financial Analysis & Valuation
Data Analysis
Virtual Assistance
Microsoft Word
Microsoft Excel
Microsoft Access
Data Entry
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