Regulatory Medical Writer (Remote)
Full-time
USA
The job listing has expired. Unfortunately, the hiring company is no longer accepting new applications.
To see similar active jobs please follow this link: Remote Healthcare jobs
To see similar active jobs please follow this link: Remote Healthcare jobs
Job Description
Job Type: Contract
Length: 4 Months (Renewable)
Compensation: Negotiable
Job Description:
- Provides high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. Provides technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Effectively manages medical writing projects to deliver quality products in agreed timelines. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
- Independently researches, writes, and edits clinical study reports, study protocols and standard response documents. Produces complex clinical or scientific documents, such as, IBs, and sections of INDs, NDAs, CTDs, and dossiers. Provides senior review of documents and training/mentoring for other writers.
- Manages all aspects of planning, organizing, and executing projects without supervision including: developing project timelines, standards, budgets, forecasts, and contract modifications. Liaises with other functional units as necessary (i.e., project management, clinical, QA, data management, biostatistics, regulatory). Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions.
- May manage several long-term projects concurrently.
- Represents Medical Writing in Project Launch Meetings, Review meetings, client audits, bid defenses, and capabilities presentations.
- Establishes and develops client relationships; independently initiates and leads interactions with clients.
- Assists with business development and development of budgets and proposals.
Education and Experience:
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
TechData Service Company, LLC (TechData) is a well-known provider of talented IT and data science professionals. Our extensive knowledge of and focus on the pharmaceutical and biotechnology research industries means that we are accomplished at providing the most qualified and high-level expert services in the pharmaceutical industry. We pride ourselves on our ability to provide technology solutions for each client, with the goals of maximizing cost saving and improving productivity. Our current available resources include professionals in clinical research, medical writing, regulatory affair , software development, and data science professionals in clinical data management, statistics and SAS/statistical programming.
Regulatory Medical Writer (Remote)
The job listing has expired. Unfortunately, the hiring company is no longer accepting new applications.
To see similar active jobs please follow this link: Remote Healthcare jobs
To see similar active jobs please follow this link: Remote Healthcare jobs
Job Description
Job Type: Contract
Length: 4 Months (Renewable)
Compensation: Negotiable
Job Description:
- Provides high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. Provides technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Effectively manages medical writing projects to deliver quality products in agreed timelines. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
- Independently researches, writes, and edits clinical study reports, study protocols and standard response documents. Produces complex clinical or scientific documents, such as, IBs, and sections of INDs, NDAs, CTDs, and dossiers. Provides senior review of documents and training/mentoring for other writers.
- Manages all aspects of planning, organizing, and executing projects without supervision including: developing project timelines, standards, budgets, forecasts, and contract modifications. Liaises with other functional units as necessary (i.e., project management, clinical, QA, data management, biostatistics, regulatory). Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions.
- May manage several long-term projects concurrently.
- Represents Medical Writing in Project Launch Meetings, Review meetings, client audits, bid defenses, and capabilities presentations.
- Establishes and develops client relationships; independently initiates and leads interactions with clients.
- Assists with business development and development of budgets and proposals.
Education and Experience:
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
TechData Service Company, LLC (TechData) is a well-known provider of talented IT and data science professionals. Our extensive knowledge of and focus on the pharmaceutical and biotechnology research industries means that we are accomplished at providing the most qualified and high-level expert services in the pharmaceutical industry. We pride ourselves on our ability to provide technology solutions for each client, with the goals of maximizing cost saving and improving productivity. Our current available resources include professionals in clinical research, medical writing, regulatory affair , software development, and data science professionals in clinical data management, statistics and SAS/statistical programming.