Senior Specialist, Medical Writing, Quality Control

Job not on LinkedIn

November 25

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $90k - $115k / year

⏰ Full Time

🟠 Senior

✏️ Content Writer

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Crinetics Pharmaceuticals

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals is a biotechnology company that develops innovative therapies for endocrine diseases. The company is focused on addressing unmet medical needs by creating treatments for conditions such as acromegaly, carcinoid syndrome, ACTH-dependent Cushing’s syndrome, congenital adrenal hyperplasia, and other endocrine disorders. Crinetics is committed to improving the quality of life for patients through cutting-edge science and robust clinical trials. Their pipeline includes promising candidates like paltusotine, which has been accepted by the U. S. Food and Drug Administration for the treatment of adult patients with acromegaly. The company collaborates with healthcare practitioners and stakeholders to ensure that their therapies address real-life problems effectively and build value for investors by entering market niches with significant needs.

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Conducting quality control (QC) review of clinical and regulatory documents, reports, data tables, and slide presentations in support of drug development • Assisting with the oversight of QC projects assigned to contractors and CROs • Performing comprehensive QC reviews of clinical and regulatory documents, reports, data tables, and slide presentations in accordance with predefined, ambitious timelines • Editing documents for grammar, punctuation, consistency, and adherence to internal style guides and regulatory requirements • Collaborating with medical writers, regulatory affairs, and cross-functional teams to resolve discrepancies and ensure document quality • Organizing complex QC projects and providing guidance to other QC reviewers • Supporting authoring process for plain language documents, including but not limited to informed consent forms and plain language protocol synopses • Assisting in maintaining and updating Crinetics Style Guide • Supporting medical writing activities with supervision as needed • Completing other tasks as assigned

🎯 Requirements

• 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 • 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.

🏖️ Benefits

• top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • winter company shutdown • discretionary annual target bonus • stock options • ESPP • 401k match