Medical Writer, Data Management

Medical Writer, Data Management
Position Summary

The Medical Writer works directly with the medical project team to develop scientifically valid and complete documents for regulatory submission, conferences and publications such as abbreviated or full clinical study reports, Investigator Brochures and other documents, as needed. The Medical Writer reports to the Head of Data Management.
Role and Responsibilities

  • Summarizes data from Clinical studies

  • Writes and edits clinical study reports for regulatory agencies and other stakeholders in accordance with ICH guidelines, standard operating procedures and AMA writing styles, adhering to project timelines.

  • Initiates and maintains communications with relevant medical team members from other functional within and outside the Medical Department

  • Provides guidance on submission strategy, tactics and tools to insure the timely submission of high quality, critical documents.

  • Actively participates in project team meetings to provide input regarding deliverables, timelines and processes for the completion of documents

  • Assists in the development of project timelines, Standard Operating Procedures and guidance documents

  • Administrates as appropriate the receipt, collation and incorporation of review comments needed for completion of regulatory and other documents, as needed.

Develops a comprehensive understanding of study design, objectives, analyses plans, and results

  • The ideal candidate will possess an advanced scientific degree (MS, PharmD or PhD).

  • 5 or more years of medical writing experience in the pharmaceutical or biotechnology industry or at a CRO including experience in the following areas of medical writing: clinical protocols, CSRs, IBs, clinical section of the IND, and BLA/NDA (ISS/Client)

  • Experience with eCTD and electronic document management systems

  • Knowledge with ICH, GCP, and regulatory guidelines

Experience and Skills

  • Attention to detail ? style, grammar, syntax, scientific accuracy

  • Ability to work professionally and proactively with diverse team members

  • Excellent verbal and written communication and the ability to write and edit complex material to ensure accuracy clarity and effectiveness

  • Understanding of the drug development process

  • Current knowledge of US and EU regulatory requirements and guidelines for documents; knowledge of eCTD requirements with respect to structure, format and content

  • Strong PC Experience and demonstrated proficiency with the MS Office Suite applications, Adobe Acrobat, and electronic document management systems

Company Description:

About Ascent:

Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent's fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.

If you are ready to propel your career to new heights†read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

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