Full-Time
Medical Writer
Integrated Resources
501-1,000 employees
No salary listed
Groton, CT, USA
In Person
 Content & Writing (1) |
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- Scientific/medical academic background (e.g., MD, DVM, PhD in relevant field, BSN, PharmD, Master’s or Bachelors’ degree in relevant field), or equivalent.
- Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy.
- Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents.
- Able to complete and turn around high quality outputs with only minimal guidance from management.
- Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products.
- High quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs.
- Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management.
- Develop and sustain constructive relationships within WSR, and with Development Operations, Clinical, and other key stakeholders.
- Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents.
- Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents.
- Manage contract writers, as well as internal writers.
- Highly organized, ability to prepare technical reports, summaries, protocols, and quantitative analyses
- Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences. Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance.
- Experience with oncology and eCTD filing preferred
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Edison, New Jersey
Founded
1996
Simplify's Take
What believers are saying
- Certification boosts appeal to quality-focused healthcare organizations.
- Reskilling programs cut time-to-hire amid workforce shortages.
- Positions IRI among 15,000 Joint Commission-accredited elite firms.
What critics are saying
- Certification lapses in 12-18 months from failed onsite review.
- Patient complaints trigger decertification and client losses in 6-12 months.
- AMN Healthcare captures IRI's mid-sized clients in 12-24 months.
What makes Integrated Resources unique
- Joint Commission Gold Seal certifies IRI's staffing compliance since 2009.
- AI tool Nova hybridizes with reskilling to close healthcare skills gaps.
- Focuses on diversity hiring and performance monitoring for elite placements.
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Benefits
Wellness Program
Mental Health Support
Flexible Work Hours
Phone/Internet Stipend
Home Office Stipend
Conference Attendance Budget
Company News
Edison, New Jersey - Integrated Resources Inc. has earned The Joint Commission's Gold Seal of Approval(R) for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.
Integrated Resources Inc. has earned The Joint Commission’s Gold Seal of Approval ® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.