Medical Writer
Hi All,I do have below requirement which is for our Direct client. Please let me know your are interested.Role: Medical Writer
Location: Woodcliff
Lake, NJ
Duration: Contract
Job Description:
Work
directly with clinical study teams, the Oncology medical writing
teams, regulatory affairs personnel, and the publishing group in the
preparation of scientifically valid regulatory documents. Responsibilities include
preparation of regulatory documents on behalf of Eisai in accordance with the
ICH guidelines, international regulations, Eisai standards and processes, and
the Eisai Writing Style Guide as applicable. Documents include but are not
limited to: Protocols and protocol amendments, clinical study reports,
Investigator brochures, and submission documents. Participate in project team
meetings to provide input regarding deliverables, timelines, and processes.
Responsible for managing the document review process. Route documents for
approval. The medical writer should be familiar with ICH
guidelines and the current AMA Style Manual. The writer will be
expected to format and manage long documents with multiple review cycles and
tight deadlines.
Qualifications:
·
Bachelor's
degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD
preferred.
·
Excellent
regulatory writing skills, meticulous attention to detail, proficiency using an
electronic document management system and standard style guide, and strong
analytical ability to interpret clinical data.
Experience: 5+ years’ writing experience in the
pharmaceutical industry.
We
are looking for someone with experience working as a MW for a major Pharma.
Prior experience in oncology is a plus. The most important requirement is the
ability to independently write regulatory documents in collaboration with the
various members of study team.
Location: Woodcliff
Lake, NJ
Duration: Contract
Job Description:
Work
directly with clinical study teams, the Oncology medical writing
teams, regulatory affairs personnel, and the publishing group in the
preparation of scientifically valid regulatory documents. Responsibilities include
preparation of regulatory documents on behalf of Eisai in accordance with the
ICH guidelines, international regulations, Eisai standards and processes, and
the Eisai Writing Style Guide as applicable. Documents include but are not
limited to: Protocols and protocol amendments, clinical study reports,
Investigator brochures, and submission documents. Participate in project team
meetings to provide input regarding deliverables, timelines, and processes.
Responsible for managing the document review process. Route documents for
approval. The medical writer should be familiar with ICH
guidelines and the current AMA Style Manual. The writer will be
expected to format and manage long documents with multiple review cycles and
tight deadlines.
Qualifications:
·
Bachelor's
degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD
preferred.
·
Excellent
regulatory writing skills, meticulous attention to detail, proficiency using an
electronic document management system and standard style guide, and strong
analytical ability to interpret clinical data.
Experience: 5+ years’ writing experience in the
pharmaceutical industry.
We
are looking for someone with experience working as a MW for a major Pharma.
Prior experience in oncology is a plus. The most important requirement is the
ability to independently write regulatory documents in collaboration with the
various members of study team.
