Senior Medical Writer (Regulatory)
Proclinical is seeking a Senior Medical Writer (Regulatory) for an innovative biotech company located in New Jersey.
Must be eligible to work in the US.
Job
Responsibilities:
Medical writing to include but not limited to annual reports, Investigator's Brochures, protocols/amendments, CSRs, manuscripts, regulatory submissions that reference/summarize clinical data.
Researches, writes and edits pre-clinical and/or clinical reports, summarizing data from pre-clinical and/or clinical studies.
Prepares clinical reports, summary documents, package inserts and other documents that may be submitted to the Food and Drug Administration and other regulatory authorities worldwide, for publication and/or presentation.
Assists in the development of formats and guidelines for clinical documentation.
May prepare scientific manuscripts, abstracts and posters.
May also support clinical research associates and medical doctors in clinical protocol development.
Keeps abreast of professional information and technology through conferences.
Perform literature reviews and solicit input from medical, statistical and operational resources as necessary to support document content.
May assist other departments (regulatory, research) with writing projects on an ad-hoc basis.
Ability to assist with other clinical science activities (review of data to ensure cleanliness/appropriateness for analysis, QA of statistical output, and data compilation to support data summaries/presentations) considered a plus.
Skills and Requirements:
Strong medical writing skills:
takes ownership of document, organizes timeline, works with co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar.
Strong analytical mind, excellent written/verbal communication skills, attention to detail, and organizational skills.
Knowledge of and experience in clinical development.
Ability to work independently, prioritize, and multitask to meet timelines under changing conditions.
Ability to collaborate in a matrixed environment and work as part of a cross-functional team.
Ability to develop collaborative working relationships with contracted vendors.
Strong document management skills, including proficiency with MS Word, EndNote, Excel, and PowerPoint.
BA/BS/RN degree or equivalent in a scientific or health care field required.
Advanced degree (MS, MPH, PhD, or PharmD) Preferred 3-5 years medical writing responsibilities Medical writing experience authoring clinical protocols/amendments, regulatory documents (IND sections, clinical study reports, Investigator's Brochures), as well as scientific publication and presentations.
Experience in inflammatory/ immunologic diseases preferable.
If you are having difficulty in applying or if you have any questions, please contact Patrick Mooney at +(1) 619-963-2702 or email protected .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-PM2 Strong medical writing skills:
takes ownership of document, organizes timeline, works with co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar.
o Strong analytical mind, excellent written/verbal communication skills, attention to detail, and organizational skills.
o Knowledge of and experience in clinical development.
o Ability to work independently, prioritize, and multitask to meet timelines under changing conditions.
o Ability to collaborate in a matrixed environment and work as part of a cross-functional team.
o Ability to develop collaborative working relationships with contracted vendors.
o Strong document management skills, including proficiency with MS Word, EndNote, Excel, and PowerPoint.
o BA/BS/RN degree or equivalent in a scientific or health care field required.
Advanced degree (MS, MPH, PhD, or PharmD) o Preferred 3-5 years medical writing responsibilities o Medical writing experience authoring clinical protocols/amendments, regulatory documents (IND sections, clinical study reports, Investigator's Brochures), as well as scientific publication and presentations.
o Experience in inflammatory/ immunologic diseases preferable.
Recommended Skills Advertising Analytical Attention To Detail Clinical Development Clinical Research Clinical Study Reports Estimated Salary: $20 to $28 per hour based on qualifications.
Must be eligible to work in the US.
Job
Responsibilities:
Medical writing to include but not limited to annual reports, Investigator's Brochures, protocols/amendments, CSRs, manuscripts, regulatory submissions that reference/summarize clinical data.
Researches, writes and edits pre-clinical and/or clinical reports, summarizing data from pre-clinical and/or clinical studies.
Prepares clinical reports, summary documents, package inserts and other documents that may be submitted to the Food and Drug Administration and other regulatory authorities worldwide, for publication and/or presentation.
Assists in the development of formats and guidelines for clinical documentation.
May prepare scientific manuscripts, abstracts and posters.
May also support clinical research associates and medical doctors in clinical protocol development.
Keeps abreast of professional information and technology through conferences.
Perform literature reviews and solicit input from medical, statistical and operational resources as necessary to support document content.
May assist other departments (regulatory, research) with writing projects on an ad-hoc basis.
Ability to assist with other clinical science activities (review of data to ensure cleanliness/appropriateness for analysis, QA of statistical output, and data compilation to support data summaries/presentations) considered a plus.
Skills and Requirements:
Strong medical writing skills:
takes ownership of document, organizes timeline, works with co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar.
Strong analytical mind, excellent written/verbal communication skills, attention to detail, and organizational skills.
Knowledge of and experience in clinical development.
Ability to work independently, prioritize, and multitask to meet timelines under changing conditions.
Ability to collaborate in a matrixed environment and work as part of a cross-functional team.
Ability to develop collaborative working relationships with contracted vendors.
Strong document management skills, including proficiency with MS Word, EndNote, Excel, and PowerPoint.
BA/BS/RN degree or equivalent in a scientific or health care field required.
Advanced degree (MS, MPH, PhD, or PharmD) Preferred 3-5 years medical writing responsibilities Medical writing experience authoring clinical protocols/amendments, regulatory documents (IND sections, clinical study reports, Investigator's Brochures), as well as scientific publication and presentations.
Experience in inflammatory/ immunologic diseases preferable.
If you are having difficulty in applying or if you have any questions, please contact Patrick Mooney at +(1) 619-963-2702 or email protected .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-PM2 Strong medical writing skills:
takes ownership of document, organizes timeline, works with co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar.
o Strong analytical mind, excellent written/verbal communication skills, attention to detail, and organizational skills.
o Knowledge of and experience in clinical development.
o Ability to work independently, prioritize, and multitask to meet timelines under changing conditions.
o Ability to collaborate in a matrixed environment and work as part of a cross-functional team.
o Ability to develop collaborative working relationships with contracted vendors.
o Strong document management skills, including proficiency with MS Word, EndNote, Excel, and PowerPoint.
o BA/BS/RN degree or equivalent in a scientific or health care field required.
Advanced degree (MS, MPH, PhD, or PharmD) o Preferred 3-5 years medical writing responsibilities o Medical writing experience authoring clinical protocols/amendments, regulatory documents (IND sections, clinical study reports, Investigator's Brochures), as well as scientific publication and presentations.
o Experience in inflammatory/ immunologic diseases preferable.
Recommended Skills Advertising Analytical Attention To Detail Clinical Development Clinical Research Clinical Study Reports Estimated Salary: $20 to $28 per hour based on qualifications.
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