Medical Writer Job

MEDICAL WRITER needed for a contract opportunity with Yoh's client located in Cambridge, MA.

WHAT YOU'LL BE DOING:

- The purpose of this job is to create and to manage creation by others of any type of clinical regulatory document (eg, protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format.
- This position is for an independent, proactive, very experienced medical writer with demonstrated leadership in preparing multiple key summary submission documents (ie, Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) for the CTD and demonstrated experience managing the project work of other medical writers.
- As an integral part of a clinical and/or study team, the position holder ensures the quality, compliance with internal and external standards, and timely and efficient production of English-language clinical documents using an electronic document management system.
- The position holder must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers
- Managing document completion when working on teams in which some members are new to the company or role, and are not familiar with expectations, roles or company procedures.
- Managing completion of high-quality documents on time when deliverables are late, incomplete, or of poor quality

WHAT YOU NEED TO BRING TO THE TABLE:

- Substantial experience eight to ten (8 - 10) years as a medical writer, or equivalent, and presenting relevant specialist qualifications (eg, Ph.D. in life sciences).
- Experience leading teams to prepare clinical regulatory submission documents, including CTD Module 2 summaries.
- Specific knowledge of clinical development in a variety of therapeutic areas is strongly desirable, as is submission experience with pharmaceuticals and/or biological agents

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a DayJ2W: CLINICAL

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