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: Research Analyst - Medical Writing & Publishing-547650
Job Description:
- Individual Contributor Role with hands on experience in publishing software to produce electronic deliverables to ensure insertion of navigability features, and accurate intra-document hyperlinking, according to SOP/client/regulatory requirements - Perform MS Word formatting of clinical documents according to SOP/client/regulatory requirements.
- Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
- Independently compile appendices to clinical study reports in compliance with appropriate regulatory requirements.
- Work with internal or external Clinical and/or Project Leadership functions to ensure that appendix documentation is complete and complies with the relevant guidelines. - Perform scanning and uploading of paper documents
- Publish quality submission outputs in accordance with agreed processes, timelines, formats and standards.
- Liaise with senior publishing colleagues and strategic author team members, both locally & globally, to ascertain individual submission requirements for specific countries & their regulatory bodies.
- Advanced word processing skills in MS Word/Office. Ability to apply formatting to template documents, perform quality checks, edit tables and figures within templates, and verify template data against source documents. Advanced PDF processing skills in Adobe Acrobat
- Gain clear understanding of submission ready requirements and develop a good working knowledge of all tools/systems used in support of publishing processes.
- Publish quality submission outputs in accordance with agreed processes, timelines, formats and standards.
- Maintain regular communication channel to keep teams apprised of the status of submission publication activities
- Flexible attitude with respect to work assignments and new learning - Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail
- Demonstrate constant attention to detail to ensure each submission package is correct & in the required format and delivered in a timely manner to expedite publication.
- Ability to work in a matrix environment and to value the importance of teamwork, connecting with a broad range of cultures
- Ability to manage workload capacity with ever changing deadlines/requirements with ability to assist & support other members of the team where required.
Candidate Profile:
- 2-3 years of experience within large Pharma / Healthcare organizations (or) Service providers or CROs servicing large Pharma / Healthcare organization.
- 1-2 years of experience in medical writing & publishing of eCTD, NeeS and Paper submissions using various publishing tools; Experience in Documentum-based dossier repositories.
- Degree in Pharmacy, Lifesciences, Microbiology, Marketing is desirable bit not essential
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- Extensive exposure in following areas for Regulatory Support: Compliance checking, Hyper-linking, bookmarking, QC/ review of documents, Rendering Multiple documents to PDF, Creation of external links, Completion of Modules 1-5 in eCTD format, Compilation of NeeS, Compilation of paper submission, QC/ review of dossier, Publishing & Validation.
- Good working knowledge of tools/systems used in support of publishing processes, in particular eCTDXpress, ISIPublisher, ISIToolbox, Compose etc.
- Good understanding of existing regulatory agency standards and formats for submission and ensure that the CMC publishing output meets these requirements.
- Good knowledge of ICH/ regional eCTD guideline.
- Degree in Pharmacy, Lifesciences, Microbiology, Marketing is desirable bit not essential
- Ability to travel as needed (including internationally)
Additional Information:
Exp: 2-3 Years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writer
End Date: 31th March, 2014
Job ID: 547650
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