Lifelancer
Job Title:
Medical Writer Job Location:
San Rafael CA USA Job Location Type:
Remote Job Contract Type:
Contract Job Seniority Level:
Associate Job Order #: 329444
Title of Position: Medical Writer
Location: San Rafael CA (Hybrid preferred 100% Remote is fine)
Type: Contract
Pay Rate: $53/hr. W2 ONLY (NO STEM OPT CANDIDATES)
The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development drafting review editing and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
Responsibilities
Drafts and edits documents used for submissions including CTDs and RtQs Drafts and edits documents used in conducting and reporting the results of clinical studies including protocols protocol amendments and informed consent forms Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule such as investigator's brochures and periodic safety reports (PSURs DSURs etc.) Manages study team participation in the preparation of such documents including calling/running meetings developing and managing timelines and managing the document review and comment adjudication processes Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Works effectively with crossfunctional groups within client. Other tasks as assigned.
SUPERVISOR RESPONSIBILITY None.
CONTACTS
Clinical Medical Writing Biostatistics Clinical Data Management Statistical Programming Clinical Operations Medical Affairs Medical Directors Regulatory Affairs Legal Commercial Pharmacology/Toxicology Corporate Compliance Project management Pharmacovigilance.
EQUIPMENT
Access to corporate computer network production computing environment and MS Windows software.
Skills
Fulfills one of the following:
Medical writer in the pharmaceutical industry Medical or scientific writing experience as a primary job responsibility
Skill and Experience: At least 5 years experience required
Familiar with the drug development process (discovery to market) clinical study protocol design and study conduct and documentation required for the conduct of clinical studies.
Familiar with clinical study data collection and results reporting.
Previous protocol development experience required.
Experience writing reviewing or editing protocols and clinical study reports highly preferred.
Experience writing reviewing or editing INDs and BLA/NDAs highly preferred.
Intermediate to advanced applied knowledge of routine document content preparation including the use of style guides medical dictionaries and guidance documents that prescribe content.
Intermediate to advanced applied knowledge of AMA CBE and Chicago Style Manuals.
Ability to interpret basic tabular and graphical clinical data presentations.
Ability to create basic tables using AMA style (eg Schedule of Events).
Intermediate applied knowledge of basic clinical laboratory tests.
Basic understanding of the concepts of coding dictionaries (MedDRA WHO Drug).
Basic understanding of biostatistical and clinical research concepts. Proficient in Microsoft Word (including the use of templates) Excel and PowerPoint.
Experienced with scanners printers and copiers. Basic knowledge of regulatory requirements and guidance's associated with 'standalone' regulatory documents (e.g. protocols investigator brochures and clinical study reports).
Capable of working on multiple tasks and shifting priorities. Capable of leading a crossfunctional team under strict timelines including calling/running meetings and managing team review and comment adjudication stages of document preparation. Good conflict management skills. Motivated and shows initiative.
Detail oriented. Capable of well organized concise and clear written and verbal communication. Capable of comprehending complex scientific concepts and translating them into clear concise appropriately referenced text that meets regulatory requirements.
Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.
Keywords
Education: EDUCATION
Bachelor's or higher degree; scientific focus desirable.
Evidence of medical writing career development desirable eg American or European Medical Writers Association certificate Editor in Life Sciences certificate or relevant training through Drug Information Association.
Lifelancer (
) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.
For more details and to find similar roles please check out the below Lifelancer link. /jobs/view/6d06cd9b05512e303d5c2a0ce89339d7
Apply on Lifelancer Platform
Medical Writer Job Location:
San Rafael CA USA Job Location Type:
Remote Job Contract Type:
Contract Job Seniority Level:
Associate Job Order #: 329444
Title of Position: Medical Writer
Location: San Rafael CA (Hybrid preferred 100% Remote is fine)
Type: Contract
Pay Rate: $53/hr. W2 ONLY (NO STEM OPT CANDIDATES)
The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development drafting review editing and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
Responsibilities
Drafts and edits documents used for submissions including CTDs and RtQs Drafts and edits documents used in conducting and reporting the results of clinical studies including protocols protocol amendments and informed consent forms Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule such as investigator's brochures and periodic safety reports (PSURs DSURs etc.) Manages study team participation in the preparation of such documents including calling/running meetings developing and managing timelines and managing the document review and comment adjudication processes Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Works effectively with crossfunctional groups within client. Other tasks as assigned.
SUPERVISOR RESPONSIBILITY None.
CONTACTS
Clinical Medical Writing Biostatistics Clinical Data Management Statistical Programming Clinical Operations Medical Affairs Medical Directors Regulatory Affairs Legal Commercial Pharmacology/Toxicology Corporate Compliance Project management Pharmacovigilance.
EQUIPMENT
Access to corporate computer network production computing environment and MS Windows software.
Skills
Fulfills one of the following:
Medical writer in the pharmaceutical industry Medical or scientific writing experience as a primary job responsibility
Skill and Experience: At least 5 years experience required
Familiar with the drug development process (discovery to market) clinical study protocol design and study conduct and documentation required for the conduct of clinical studies.
Familiar with clinical study data collection and results reporting.
Previous protocol development experience required.
Experience writing reviewing or editing protocols and clinical study reports highly preferred.
Experience writing reviewing or editing INDs and BLA/NDAs highly preferred.
Intermediate to advanced applied knowledge of routine document content preparation including the use of style guides medical dictionaries and guidance documents that prescribe content.
Intermediate to advanced applied knowledge of AMA CBE and Chicago Style Manuals.
Ability to interpret basic tabular and graphical clinical data presentations.
Ability to create basic tables using AMA style (eg Schedule of Events).
Intermediate applied knowledge of basic clinical laboratory tests.
Basic understanding of the concepts of coding dictionaries (MedDRA WHO Drug).
Basic understanding of biostatistical and clinical research concepts. Proficient in Microsoft Word (including the use of templates) Excel and PowerPoint.
Experienced with scanners printers and copiers. Basic knowledge of regulatory requirements and guidance's associated with 'standalone' regulatory documents (e.g. protocols investigator brochures and clinical study reports).
Capable of working on multiple tasks and shifting priorities. Capable of leading a crossfunctional team under strict timelines including calling/running meetings and managing team review and comment adjudication stages of document preparation. Good conflict management skills. Motivated and shows initiative.
Detail oriented. Capable of well organized concise and clear written and verbal communication. Capable of comprehending complex scientific concepts and translating them into clear concise appropriately referenced text that meets regulatory requirements.
Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.
Keywords
Education: EDUCATION
Bachelor's or higher degree; scientific focus desirable.
Evidence of medical writing career development desirable eg American or European Medical Writers Association certificate Editor in Life Sciences certificate or relevant training through Drug Information Association.
Lifelancer (
) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.
For more details and to find similar roles please check out the below Lifelancer link. /jobs/view/6d06cd9b05512e303d5c2a0ce89339d7
Apply on Lifelancer Platform