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Principal Regulatory Strategist (CRO / Pharma Industry) - Remote

Principal Regulatory Strategist (CRO / Pharma Industry) - Remote

MMSZionsville, IN, US
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Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research o...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Technical content writer

Technical content writer

I3 INFOTEK INCCarmel, IN, US
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Looking for a Technical Content Writer experienced in software documentation and.The role involves creating clear, concise manuals, guides, and software documentation for engineers, operators, and ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Senior Manager, Content Creation

Senior Manager, Content Creation

MediabistroCarmel, IN, United States
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Media & Influencer Activation | New York, NY.Senior Manager, Content Creation.OTHER LOCATIONS : Boston, MA | San Francisco, CA | Carmel, IN | Chicago, IL. Working at Real Chemistry and in the healthc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Wealth Strategist

Wealth Strategist

Oxford Financial Group, Ltd.Carmel, IN, United States
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The Wealth Strategist plays a key role in producing and reviewing complex client estate and wealth transfer planning deliverables and serves as an estate and financial planning technical resource f...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Wealth Strategist

Wealth Strategist

Oxford Financial Group, LtdCarmel, IN
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The Wealth Strategist plays a key role in producing and reviewing complex client estate and wealth transfer planning deliverables and serves as an estate and financial planning technical resource f...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Content Analyst Job at Allied Solutions LLC in Carmel

Content Analyst Job at Allied Solutions LLC in Carmel

Allied Solutions LLCCarmel, IN, United States
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The Content Analyst plays an important role collaborating with the Sr.Content Analyst on establishing and implementing a vision for enterprise content management and partnering with other operating...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Digital Content Manager

Digital Content Manager

Nexstar Media GroupIN, Indianapolis;6910 Network Place
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FOX59, the #1 newsroom in Indianapolis, is looking for a.TV (CTV) and digital video platforms, including the FOX59 NOW app (for Roku, Amazon Fire and Apple TV). This is a hands-on, creative role tha...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Agency Account Strategist

Agency Account Strategist

PrecoaNoblesville, IN, US
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Description Position at @need Marketing Account Strategist Build Strategic Partnerships That Drive Meaningful Growth Shape the future of funeral home marketing while building trusted relationships ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
eLearning Specialist Content & Engagement

eLearning Specialist Content & Engagement

Viega GmbH & Co. KGField, US
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Job-ID : 14503; Location(s) : Field .The e-Learning Specialist works with the Viega Content and Engagement team to design, author, and implement engaging learning for the plumbing and mechanical pipi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Senior Manager, Content Creation

Senior Manager, Content Creation

W2O GroupCarmel, IN, United States
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Working at Real Chemistry and in the healthcare industry isnt just a job for us.We got into this field for different reasons, but we all stay for the same reason to uncover insights, make meaningfu...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
Senior Manager, Content Creation

Senior Manager, Content Creation

Real ChemistryCarmel, IN, United States
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Media & Influencer Activation | New York, NY.Senior Manager, Content Creation.OTHER LOCATIONS : Boston, MA | San Francisco, CA | Carmel, IN | Chicago, IL. Working at Real Chemistry and in the healthc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Recruitment Marketing Content Development Analyst

Recruitment Marketing Content Development Analyst

Sacred Heart UniversityCarmel, IN, United States
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Recruitment Marketing Content Development Analyst.Bring your creativity to our fast-paced recruitment marketing team! We’re seeking a motivated entry level content creator for a full-time contract ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Principal Regulatory Strategist (CRO / Pharma Industry) - Remote

Principal Regulatory Strategist (CRO / Pharma Industry) - Remote

MMSZionsville, IN, US
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Job Description

Job Description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com  or follow MMS on LinkedIn.

This would be a full-time role, working remotely.

Responsibilities :

  • Provide consulting and advisory services for complex regulatory issues or projects.
  • Author and maintain documentation as required to sustain regulatory compliance.
  • Provide senior technical review for complex regulatory projects.
  • Provide cross-functional team leadership and management of multiple stakeholders across diverse projects
  • Conduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory intelligence reports.
  • Participate in project teams and provide expertise on related regulatory matters.
  • Clearly and accurately conveys information to peers, supervisors, and other stakeholders.
  • Participates in in implementation of new / updated operational strategies to comply with new / updated policies and recommendations.
  • Identifies new / updated policies and recommendations and may provide professional opinions on impact of regulatory changes to MMS and Clients (from the desk of, blogs, webinars, etc.).

Requirements :

  • College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred.
  • Minimum of 10 years experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (FDA).
  • Expert knowledge of regulatory principles and concepts.
  • Reputation as experienced leader with evidence of sustained performance and accomplishments.
  • Proficiency with MS Office applications.
  • Hands-on experience with clinical trial and pharmaceutical development preferred.
  • Good communication skills and willingness to work with others to clearly understand needs and solve problems.
  • Excellent problem-solving skills.
  • Good organizational and communication skills.
  • Basic understanding of CROs and scientific and clinical data / terminology, and the drug development process.
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