Planet Pharma
Senior/Principal Regulatory Medical Writer
Base pay range
$80.00/hr - $120.00/hr
Planet Pharma's client is looking for a Senior / Principal Medical Writer, who will be responsible for providing medical writing support for the development of complex clinical documents for regulatory submissions including, but not limited to clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports and other key clinical and regulatory documents. This individual will support the overall strategy for all medical writing processes according standards.
Overview Job responsibilities and expectations focus on developing, editing, and coordinating medical writing deliverables to support regulatory submissions and product development.
Key Accountabilities/Responsibilities
Support the clinical medical writing team, in developing content for, writing and editing a variety of scientific and medical documents, including clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives and annual reports
Draft and manage documents that are well-organized, accurate, consistent, and in compliance with applicable company SOPs and regulations
Ensures all clinical documents are standardized with the use of document templates, in order to ensure the quality and consistency of documentation across programs
Partner with Quality Assurance (QA) during audit of clinical documents to ensure timely response to findings
Collaborate with clinical project teams including Project Manager, Clinical Study Managers, Medical Directors and Biostatistics to ensure project deadlines are met, by providing content development support, research, and editing functions for each program
Ensure proper development and coaching of junior writers
Desired Skills and Experience
Basic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
Ability to proofread documents for compliance with internal and external guidance documents
Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion
Ability to work precisely according to procedures and regulations.
Excellent written and verbal communication skills
Ability to prioritize and multi-task successfully in a fast-paced environment.
Ability to work autonomously, as well as in a team
Excellent time management skills and a proven ability to work on multiple projects at any given time
Must be proficient in MS Office
Experience in electronic publishing format preferred
Education and Qualifications
Bachelor’s degree in a scientific, medical or clinical discipline or related field required, PhD preferred
Minimum of 3-5 years of pharmaceutical/biotechnology related medical writing experience required
Knowledge of all FDA and ICH guidelines for clinical reporting required.
eCTD development, publishing and submission experience preferred
Therapeutic experience in biologics preferred
Bachelor’s degree in a scientific or clinical discipline or related field or equivalent experience required; PhD preferred
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Writing/Editing
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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$80.00/hr - $120.00/hr
Planet Pharma's client is looking for a Senior / Principal Medical Writer, who will be responsible for providing medical writing support for the development of complex clinical documents for regulatory submissions including, but not limited to clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports and other key clinical and regulatory documents. This individual will support the overall strategy for all medical writing processes according standards.
Overview Job responsibilities and expectations focus on developing, editing, and coordinating medical writing deliverables to support regulatory submissions and product development.
Key Accountabilities/Responsibilities
Support the clinical medical writing team, in developing content for, writing and editing a variety of scientific and medical documents, including clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives and annual reports
Draft and manage documents that are well-organized, accurate, consistent, and in compliance with applicable company SOPs and regulations
Ensures all clinical documents are standardized with the use of document templates, in order to ensure the quality and consistency of documentation across programs
Partner with Quality Assurance (QA) during audit of clinical documents to ensure timely response to findings
Collaborate with clinical project teams including Project Manager, Clinical Study Managers, Medical Directors and Biostatistics to ensure project deadlines are met, by providing content development support, research, and editing functions for each program
Ensure proper development and coaching of junior writers
Desired Skills and Experience
Basic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
Ability to proofread documents for compliance with internal and external guidance documents
Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion
Ability to work precisely according to procedures and regulations.
Excellent written and verbal communication skills
Ability to prioritize and multi-task successfully in a fast-paced environment.
Ability to work autonomously, as well as in a team
Excellent time management skills and a proven ability to work on multiple projects at any given time
Must be proficient in MS Office
Experience in electronic publishing format preferred
Education and Qualifications
Bachelor’s degree in a scientific, medical or clinical discipline or related field required, PhD preferred
Minimum of 3-5 years of pharmaceutical/biotechnology related medical writing experience required
Knowledge of all FDA and ICH guidelines for clinical reporting required.
eCTD development, publishing and submission experience preferred
Therapeutic experience in biologics preferred
Bachelor’s degree in a scientific or clinical discipline or related field or equivalent experience required; PhD preferred
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Writing/Editing
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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