Director, Medical Writing - San Diego, CA | Biospace
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Director, Medical Writing

Cidara Therapeutics

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Location:
San Diego, CA
Posted Date:
7/28/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Position Summary

The Director, Medical Writing has a strong background in science and knowledge of current regulations relevant to medical writing.  The position directs the preparation, writing, and review of IND and NDA documents and other regulatory documents, as well as manuscripts, abstracts, and posters, and manages resources to produce output supporting corporate goals.  The Director, Medical Writing is responsible for document timelines, including creation, implementation, and managing compliance.  This position reports to the Chief Medical Officer.

Responsibilities

Responsible for content, format, and development of documents including protocols, investigator’s brochures, clinical study reports, sections of INDs and NDAs, and clinical and nonclinical manuscripts; ensure documents have a high quality of scientific content, organization, clarity, accuracy, format, and consistency.
Develop, define, and communicate processes and timelines related to document development, incorporating electronic submission requirements.
Participate in study and clinical team meetings and assist the teams in resolving issues related to document preparation; facilitate document review meetings and discussions.
Direct the Medical Writing function, setting objectives and managing performance to ensure goal achievement.
Support planning and process efforts in preparation for the NDA submission.
Manage medical writing activities of the NDA submission.
Work closely with staff in Regulatory, Quality, Clinical, Project Management, and Nonclinical to ensure quality document production and processing.
Educate team members regarding medical writing concepts, technological writing advances, and industry writing standards.
Manage individuals and groups of contract medical writing service providers; train and guide other writers in company policies and procedures related to document preparation.
Provide general medical writing services to support department and corporate goals.
Follow applicable regulations, including FDA, ICH, and Cidara Policies and Procedures.

Requirements

Minimum Qualifications      

Advanced Degree with a minimum of 8 years of experience or Bachelor’s degree in a science or communication discipline with a minimum of 10 years medical writing experience in the clinical or laboratory setting; a combination of relevant education and applicable job experience may be considered
Excellent understanding of drug/biologic development, experimental methods, research design, and statistical analysis
Ability to analyze data and interpret its significance to clinical programs
Ability to manage multiple tasks within deadlines
Excellent written and oral communication skills
Experience writing all types of clinical and regulatory documents and with registration dossiers for worldwide use
Direct experience with eCTD and authoring NDA summary documents
Familiarity with FDA and ICH guidelines
Expertise in Word, including the ability to solve technical problems with electronic templates
Demonstrated team skills
Preferred Qualifications      

Working with CROs
Supervising employees/managing department
Writing in multiple therapeutic areas including anti-infectives
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.

Cidara Therapeutics is an E-Verify Company