| Job List |
| Job ID: |
CLM-01248-3 - Medical Writer |
| Description: |
JOB STATEMENT: Responsible for researching, writing, and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation. Assist in the development of formats and guidelines for clinical documentation. May also support CRA’s and MD’s in clinical protocol development. Keeps abreast of professional information and technology through conferences
JOB REQUIREMENTS / EDUCATION / EXPERIENCE:
Level 1:
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Requires a Bachelors/Masters degree in scientific discipline or equivalent with a minimum of 2 to 5 years experience with a Bachelors or 0-2 years with a Masters
• Demonstrated working knowledge of scientific principals.
• Normally receives no instructions on routine work, general instructions on new assignments
Level 2:
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Requires a Bachelors/Masters degree in a scientific discipline or equivalent with a minimum of 5-8 years experience with a Bachelors, or 2-5 years with a Masters and demonstrated working knowledge of scientific principals.
• May determine methods and procedures on new assignments and may provide guidance to other lower level personnel.
Level 3:
• Works on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Requires Bachelor’s/Master’s degree ina scientific discipline or equivalent with a minimum 8+ years experience with a Bachelors, or 5-8 years with a Masters and demonstrated working knowledge of scientific principals.
• Acts independently to determine methods and procedures on new assignments.
• May supervise the activities of other lower level personnel.
|
| |
Salary: OPEN,
Job Type: Permanent,
Total Exp: 2-8+ Yrs,
Start Date: ASAP,
Location: Atlanta, GA & Missassauga, ON |
| Go to Top |
Respond to this Job by eMail Respond to this Job by Web Form |
|
| Job ID: |
IN-09127-1 - Medical Writer |
| Description: |
Due to company growth, and a steadily increasing flow of regulatory documents into the clinical group, we are looking to fill a newly-created position within our Research & Development Department. This is a great opportunity for the right individual.
This is a full-time, direct hire, exempt position, and the job description is attached. The salary range is $60K to $65K, and we offer a bonus target potential of 10 percent of annual base salary.
The work hours are 8:30 AM to 5:00 PM, Monday through Friday.
In addition to salary and annual bonus, this company offers a comprehensive package of benefits including medical, dental, vision, paid life insurance and paid Long-term Disability.
|
| |
Salary: 60-65k,
Job Type: Permanent,
Total Exp: 3 Yrs,
Start Date: ASAP,
Location: Clinton, NJ |
| Go to Top |
Respond to this Job by eMail Respond to this Job by Web Form |
|
| Job ID: |
RG-11267-4 - Medical Writer |
| Description: |
Job Description:
Responsible for the writing and/or editing of a variety of scientific and medical documents and ensuring that they adhere to regulatory guidelines and departmental editorial standards. Documents include but are not limited to:
- protocols (clinical protocols (Phases I-III; IV), write clinical study outlines and protocols and draft documents in collaboration with
study team. Ensure protocol meets all regulatory and stylistic guidelines, contain an appropriate statistical analysis plan and will provide data needed for writing the CSR and scientific publications
- case reports forms,
- data tables, data listings, and data figures; ensure that statistics are presented accurately; prepare appropriate in-text tables to present data
- developing final study reports (Write clinical study reports (CSRs) for phase I; II; III; IV studies) Responsible for filing of completed CSR and appendices in repository;
- patient synopses
- investigators' brochures
- new drug applications (NDA)
- investigational new drug (IND) applications Maintain document standardization with the use of model documents/templates in order to ensure the quality of clinical project documentation
-Responsible for the QC of documents written by other authors. Responsible for proof reading own documents for consistency and compliance with internal and external guidance documents.
-Responsible for the importation of report appendix documents into a document management system. Confirms communications by obtaining required internal and external reviews; incorporating reviewer comments; proofing, editing, and revising copy; completing quality assurance checks, including case report forms (CRF) vs. protocols, statistical analysis plans (SAP) vs. protocol/annotated CFRs, data management plans (DMP) vs. protocol/annotated CFRs, case report tabulations (CRT)/listings vs. statistical analysis tables, clinical study report write-ups vs. statistical analyses and CRT/listings; obtaining final signoffs.
-Prepare clinical development plans and other clinical documentation as required Collaborate with counterparts to ensure timely preparation of publication plans and write abstracts, manuscripts and other materials as needed.
-Updates job knowledge by tracking changes in writing guidelines; participating in educational opportunities; reading professional publications; maintaining personal networks. Enhances organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments
Relocation Plan Available. |
| |
Salary: to 85k,
Job Type: Permanent,
Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
| Go to Top |
Respond to this Job by eMail Respond to this Job by Web Form |
|
| Job ID: |
PS-07076-4 - Medical/Sr Medical Writer |
| Description: |
Responsible for timely preparation of Clinical Investigator Brochures,
Clinical Development Plans (CDP), Clinical Study Reports, abstracts &
manuscripts, Integrated Summaries of Safety (ISS), Integrated Summaries of
Efficacy (ISE), Benefits/Risk Analyses, Annual Reports, etc.
Ensure high quality with regard to scientific content, organization,
clarity, accuracy, format, consistency and adherence to regulatory &
internal guidelines, styles & processes
Represent Medical Writing on clinical teams with responsibility for timely
& accurate completion of Medical Writing deliverables
Qualifications:
BS degree required, advanced degree preferred
5+ years pharmaceutical industry experience
Strong scientific, interpretive, organizational, communication, computer &
project management skills
Must be able to work efficiently in a team environment
|
| |
Salary: $80s,
Job Type: Permanent,
Total Exp: 5+ years,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
| Go to Top |
Respond to this Job by eMail Respond to this Job by Web Form |
|
| Job ID: |
PS-07076-3 - Quality Manager, Medical Writing |
| Description: |
Responsible for the overall quality control of all clinical documents
Review documents from various sources for accuracy and completion
Ensure data, tables, charts, statistical analysis, etc. in documents are
valid
Ensure there is a cohesive, uniform style and language throughout the
documents
Qualifications:
Minimum BS/BA degree in English and/or Life Sciences
5+ years experience in the pharmaceutical industry
Working knowledge of FDA and ICH Guidelines, AMA Style Guide, Medical
Terminology, and relevant The company SOPs
Excellent organizational and communication skills |
| |
Salary: $95k-$110k ,
Job Type: Permanent,
Total Exp: 5+ years,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
| Go to Top |
Respond to this Job by eMail Respond to this Job by Web Form |
|
|
|
to see the latest MEDICAL
WRITING jobs. Look for 
to see the HOT jobs.