Job Description
- Individual Contributor Role, however possess an established ability to work independently or as part of the team
- Write regulatory-based documents (protocols, clinical study reports including patient narratives, integrated safety and efficacy reports, clinical trial registry summaries, and submission documents) for submission to regulatory agencies and medical institutions
- Write clinical documents associated with submissions to regulatory authorities including but not limited to: model informed consents, interim and final clinical study reports, and safety update reports
- Ensure document content and style adheres to FDA/EMA/world-wide regulatory agencies or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
- Conduct quantitative and qualitative analyses on findings and present and interpret results in a structured, conclusion-oriented manner, to address key project objectives
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
- Review statistical analysis plans and mock statistical output to assist in determining appropriateness of content/format for clinical writing
- Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
- Assist management as needed with preparation of resourcing estimates for potential new medical writing projects.
- Initiate and participate in departmental or interdepartmental process improvement and training initiatives
- Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the function.
- Performs quality assurance functions in all aspects of technical services
- Deliver projects on-time with minimal needed oversight or supervision
- Coordinate and prioritize business needs in a matrix management environment
- Individual Contributor Role, however possess an established ability to work independently or as part of the team
- Write regulatory-based documents (protocols, clinical study reports including patient narratives, integrated safety and efficacy reports, clinical trial registry summaries, and submission documents) for submission to regulatory agencies and medical institutions
- Write clinical documents associated with submissions to regulatory authorities including but not limited to: model informed consents, interim and final clinical study reports, and safety update reports
- Ensure document content and style adheres to FDA/EMA/world-wide regulatory agencies or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
- Conduct quantitative and qualitative analyses on findings and present and interpret results in a structured, conclusion-oriented manner, to address key project objectives
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
- Review statistical analysis plans and mock statistical output to assist in determining appropriateness of content/format for clinical writing
- Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
- Assist management as needed with preparation of resourcing estimates for potential new medical writing projects.
- Initiate and participate in departmental or interdepartmental process improvement and training initiatives
- Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the function.
- Performs quality assurance functions in all aspects of technical services
- Deliver projects on-time with minimal needed oversight or supervision
- Coordinate and prioritize business needs in a matrix management environment
Candidate Profile
- 2-4 years of relevant experience in large Pharma / Healthcare organizations (or) Service providers servicing large Pharma / Clinical research organization
- 1-2 years core-experience with medical writing
- Understanding of Data Analysis stream of work & exposure to analytical tools.
- Self-starter and ability to articulate customer problems/ requirements in a systemic way and devise service strategy as appropriate.
- Exposed to using data from secondary data-bases like PubMed, Embase, Medline, Thomson Pharma, Cochran reviews etc. for project requirement
- Excellent communication skills to engage clients & team members alike & instill required enthusiasm… sound client management & team management skills
- Has proven demonstration of competency in writing clinical study reports, patient narratives, protocols, informed consent etc.
- Advanced degree in pharmacy, lifesciences, microbiology, marketing
- Ability to travel as needed (including internationally)
- 2-4 years of relevant experience in large Pharma / Healthcare organizations (or) Service providers servicing large Pharma / Clinical research organization
- 1-2 years core-experience with medical writing
- Understanding of Data Analysis stream of work & exposure to analytical tools.
- Self-starter and ability to articulate customer problems/ requirements in a systemic way and devise service strategy as appropriate.
- Exposed to using data from secondary data-bases like PubMed, Embase, Medline, Thomson Pharma, Cochran reviews etc. for project requirement
- Excellent communication skills to engage clients & team members alike & instill required enthusiasm… sound client management & team management skills
- Has proven demonstration of competency in writing clinical study reports, patient narratives, protocols, informed consent etc.
- Advanced degree in pharmacy, lifesciences, microbiology, marketing
- Ability to travel as needed (including internationally)
Additional Information:
Exp: 2-4 Years
End Date: 31th March, 2014
Exp: 2-4 Years
End Date: 31th March, 2014
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