Top 703 Medical writing manager Jobs in Pennsylvania

Manager, Medical Writer, Quality Control and Clinical and Regulatory Medical Writing (Remote)
Cabaletta Bio —Philadelphia, PA
- Remote
- Microsoft Word
- English
- Master's degree
- Health insurance
- Paid time off
Manager/ Sr Manager, Medical & Scientific Writing
OCUGEN OPCO INC —Malvern, PA
- Full-time
- Office
- 3 years
- Master's degree
- Opportunities for advancement
13d
Civil Engineering Project Manager – Land Development
Charter Homes & Neighborhoods —Lancaster, PA
- $150,000 - $200,000 a year
- Full-time
- Civil engineering
- Management
- Construction site
- Wellness program
- Health savings account
Quick Apply
Senior Specialist, Integrated Absence Manager
New York Life —Pittsburgh, PA
- $50,000 - $73,000 a year
- Full-time
- Hybrid work
- Microsoft Outlook
- Writing skills
- Mid-level
- Free parking
- Health insurance
14d
Lead Teacher
Third Street Alliance —Easton, PA
- $19 - $20 an hour
- Full-time
- School experience
- Classroom
- Management
- Paid holidays
- Disability insurance
Quick Apply
General Manager
Red Lobster —State College, PA
- $65,000 - $72,400 a year
- Full-time
- ServSafe
- 5 years
- English
- Disability insurance
- Health insurance
Customer Experience Account Manager - Custom Engineered Solutions
ABEC Inc —Bethlehem, PA
- Full-time
- Up to 50% travel
- Writing skills
- Engineering
- Paid holidays
- Health insurance
Senior Project Manager, Data Centers
Suffolk Construction Company, Inc. —Archbald, PA
- Full-time
- Oracle
- Writing skills
- Bachelor's degree
- Commuter assistance
- Fuel card
NEPA Lead / Principal Environmental Planner
GFT —Philadelphia, PA
- $140,000 - $190,000 a year
- Full-time
- Hybrid work
- 11+ years
- Driver's License
- Criminal background check
- Disability insurance
- Health insurance
Quick Apply
Senior Nuclear Engineering Manager
System One —Pittsburgh, PA
- Full-time
- Hybrid work
- Engineering
- 11+ years
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
Maintenance Manager
Niagara Bottling —Reading, PA
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Health savings account
- AD&D insurance
Quick Apply
13d
Construction Manager Technician
Pennsylvania Turnpike Commission —Middletown, PA
- $35.48 an hour
- Extended hours
- Construction site
- Basic math
- Mid-level
- Health insurance
- Dental insurance
Drug & Alcohol Case Manager
Creative Health Services, Inc —Pottstown, PA
- Full-time
- Nursing
- Addiction Medicine
- Writing skills
- Health savings account
- Health insurance
Quick Apply
4d
CUA Case Manager
Greater Philadelphia Community Alliance —Philadelphia, PA
- $60,000 a year
- Full-time
- Hybrid work
- Background check
- Spanish
- Microsoft Excel
- Health savings account
- Health insurance
Quick Apply
Program Manager
Touchstone Foundation —Lancaster, PA
- $60,000 - $72,000 a year
- 8 hour shift
- Mid-level
- Office
- 3 years
- Continuing education credits
- Paid holidays
Quick Apply
4d
Transportation Group Manager
System One —Canonsburg, PA
- $190,000 a year
- Full-time
- Hybrid work
- 5 years
- Bachelor of Science
- Microsoft Office
- Health insurance
- Dental insurance
Quick Apply
Direct Support Professional - Lead - Mundy
Beacon Specialized Living —Wilkes-Barre, PA
- $18 - $19 an hour
- Monday to Friday
- Writing skills
- Pass drug screening
- English
Quick Apply
11d
Enhanced Targeted Case Manager - $1,500 Hiring Bonus
Wesley Family Services —Westmoreland County, PA
- $21 - $23 an hour
- Full-time
- Clean driving record
- Writing skills
- HIPAA
- Paid parental leave
- Paid holidays
Quick Apply
Proposal Manager
Talson Solutions —Philadelphia, PA
- $65,000 - $85,000 a year
- Full-time
- Microsoft Excel
- Marketing
- 5 years
- Paid holidays
- Health insurance
Quick Apply
13d
REMOTE Tax Manager (International Tax) - Top 100 firm
Leoforce —Allentown, PA
- $95,000 - $150,000 a year
- Remote
- CPA
- Research
- Mid-level
- Health savings account
- Health insurance
Quick Apply

I want to receive the latest job alert for medical writing manager in pennsylvania

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

medical writing manager jobs near pennsylvania

Medical Writer jobs in Philadelphia, PA

Integration Manager jobs in Pittsburgh, PA

Nuclear Engineer jobs in Pittsburgh, PA

Case Manager jobs in Pottstown, PA

Direct Support Professional jobs in Wilkes-Barre, PA

Environmental Planner jobs in Philadelphia, PA

Program Manager jobs in Lancaster, PA

Case Manager jobs in Westmoreland County, PA

Engineering Project Manager jobs in Lancaster, PA

Maintenance Manager jobs in Reading, PA

General Manager jobs in State College, PA

Proposal Manager jobs in Philadelphia, PA

New Construction Real Estate Sales jobs in California

Construction Internship jobs in Orlando, FL

Construction Manager jobs in Harrisburg, PA

Construction Manager jobs in Ontario, CA

Construction Manager jobs in Columbia, MO

Construction jobs in Mckinney, TX

Construction Manager jobs in Kitsap County, WA

Medical Writer jobs in Denver, CO

Manager, Medical Writer, Quality Control and Clinical and Regulatory Medical Writing (Remote)

Cabaletta Bio
Philadelphia, PA

Apply Now

Job Details

Benefits

Stock options
Health insurance
Paid time off

Qualifications

Microsoft Word
Medical writing
Content creation for technical audiences
Biostatistics
Technical documentation
Presentations for conferences or internal meetings
English
ICH guidelines
Team training
Mentoring
Document viewing software
Technical training
Training & development
Technical writing experience within technology
Grammar Experience
Medical terminology

Full Job Description

About the Position

Reporting to the Senior Director, Clinical Medical Writing, the Senior Associate Medical Writer Quality Control Specialist will be a key member of the Regulatory Affairs and Clinical Development organization and interface with cell therapy clinical and regulatory personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, journal editors, NIH, clinical trial sites/investigators). The Medica/Regulatory writer works with Quality and Regulatory personnel to ensure compliance with US, EU, and ICH requirements

Responsibilities Include

Assists with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and regulatory designations (e.g. orphan drug applications, fast track, RMAT) for cell and gene therapy programs
Manages document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables.
Reviews and edits documents including those authored by others
Ensures documents are finalized for submission including publishing readiness, quality checks and finalization of all supporting literature
Supports clinical trial readiness by working with clinical operations and CROs as needed for generation/review/editing of clinical study documentation including IRB/IBC communications/responses, study manuals, etc.
Maintains consistent high quality and efficiency in the generation of technical documentation to support regulatory filings
Works with clinical and translational teams to convert technical study data and results into reports in support of regulatory submissions.
Provides training and mentoring to subject matter experts on technical writing skills and best practices
Reviews and edits documents including those authored by others both internally and externally
Is a collaborative team player participating in both internal and external project team meetings as needed, and offers proactive solutions and advice to team members
Trains on company document management systems, authors and/or reviews departmental (clinical and regulatory) SOPs as needed
Performs other activities as assigned

Required Qualifications

Bachelors or masters degree in biological sciences; with 6 years’ experience or Ph.D. and 2 years’ experience in a technical writing capacity
Familiarity with the key requirements for regulatory submissions in ICH regions as stipulated in applicable regulations and guidelines for pharmaceuticals/biologics
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IMPD, INDs, MAAs, NDAs, and BLAs, is preferred
Ability to critically analyze, synthesize, and present complex information in well-constructed documents
Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
Confidence to present to management, peers, and scientific or business collaborators
Ability to support multiple projects and to prioritize work independently
Ability to comply with company and/or industry style guides and templates
Ability to guide and train others in the writing of technical documentation
Fluent with written and spoken English with excellent attention to detail relative to consistency, grammar, syntax, and scientific accuracy
Advanced MS Skills in Word, Excel, and Adobe Pro
Strong team orientation and passion for continuous self-development.
Experience in the biotech industry or in a startup industrial setting is preferred.

How to Apply

Please click the link at the bottom of the posting to submit an application.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Apply Now

Refine Your Search

medical writing manager jobs in pennsylvania

Manager, Medical Writer, Quality Control and Clinical and Regulatory Medical Writing (Remote)

Manager/ Sr Manager, Medical & Scientific Writing

Civil Engineering Project Manager – Land Development

Senior Specialist, Integrated Absence Manager

Lead Teacher

General Manager

Customer Experience Account Manager - Custom Engineered Solutions

Senior Project Manager, Data Centers

NEPA Lead / Principal Environmental Planner

Senior Nuclear Engineering Manager

Maintenance Manager

Construction Manager Technician

Drug & Alcohol Case Manager

CUA Case Manager

Program Manager

Transportation Group Manager

Direct Support Professional - Lead - Mundy

Enhanced Targeted Case Manager - $1,500 Hiring Bonus

Proposal Manager

REMOTE Tax Manager (International Tax) - Top 100 firm

I want to receive the latest job alert for medical writing manager in pennsylvania

Related Searches

Explore jobs in more locations

About the Position

Responsibilities Include

Required Qualifications

How to Apply

Benefits

Equal Opportunity Employer

Job Seeker Tools

Employer Tools

Browse

Stay Connected