At UnitedHealth Group, their mission is to help people live healthier lives. To achieve this goal, they are focused on building a modern, adaptable, innovative and inclusive system of health care services.
Their scale and potential to improve health makes them one of the most visible stewards of America’s vast health care system. Entrusted with both important resources and responsibilities, they are involved on a daily basis in decision-making that has life-changing consequences for millions of Americans.
Post: Senior Research Analyst - Medical Writer - Late Phase-547653
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
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)
Additional Information:
Exp: 2-4 Years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writer
End Date: 31th March, 2014
Job ID: 547653
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