Senior Specialist, Medical Writing & Quality Control

Senior Specialist, Medical Writing & Quality Control page is loaded## Senior Specialist, Medical Writing & Quality Control remote type:
Remote locations:
Remote time type:
Full time posted on:
Posted Yesterday job requisition :
JR000523

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline.

We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
*
* Position Summary:

** The person in this position is responsible for conducting quality control (QC) review of clinical and regulatory documents, reports, data tables, and slide presentations in support of drug development as well as assisting with the oversight of QC projects assigned to contractors and CROs. In addition, this person is responsible for supporting medical writing activities with supervision.
** Essential Job Functions and Responsibilities:
** These may include but are not limited to:
* Perform comprehensive QC reviews of clinical and regulatory documents, reports, data tables, and slide presentations in accordance with predefined, ambitious timelines.
* Edit documents for grammar, punctuation, consistency, and adherence to internal style guides and regulatory requirements.
* Collaborate with medical writers, regulatory affairs, and cross-functional teams to resolve discrepancies and ensure document quality.
* Organize complex QC projects and provide guidance to other QC reviewers.
* Support authoring process for plain language documents, including but not limited to informed consent forms and plain language protocol synopses.
* Assist in maintaining and updating Crinetics Style Guide.
* Support medical writing activities with supervision as needed.
* Ability to work in a dynamic environment and manage changing priorities across multiple projects.
* Complete other tasks as assigned.
*
* Education and Experience:

*
* Required:

* Bachelor’s or Master’s degree in a scientific discipline required; advanced life sciences degree preferred.
* A minimum of 5 years’ experience conducting QC data reviews and editing.

Experience with regulatory documents for the biotech/pharmaceutical industry preferred (equivalent combination of experience and education considered).
* Expert attention to detail.
* Highly organized and methodical work style.
* Familiarity with electronic document control and management systems.
* Experience working on regulatory submissions (IND, NDA, MAA, NDS, etc) in eCTD format preferred.
* Excellent standard of written English, and ability to communicate fluently and effectively in written and spoken English.

Preferred:
* Ability to manage multiple projects and adapt to changing priorities for successful project completion.
* Task-oriented view of work with a commitment to timelines and deliverables.
* Excellent proficiency in MS Word with experience adhering to templates and style guides; proficient with other MS Office Suite applications, including Excel and PowerPoint.
* Experience in authoring plain language documents.
* Team-oriented with excellent communication and interpersonal skills; demonstrated ability in managing indirectly.
* Strong time management skills.
** Physical Demands and Work Environment:
** Physical

Activities:

On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to…