Associate Director, Medical Writing

Job not on LinkedIn

August 6

🏄 California – Remote

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

💵 $156k - $195k / 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

• Responsible for writing, review, and approval of clinical and regulatory documents • Collaborating across functions for document development activities • Proactively drive the document writing, review, and approval process • Develop and/or maintain integrated timelines for document generation • Coordinate and/or manage review cycles for document revision and finalization • Manage complex, multi-document outsourced writing projects • Serve as the program-level point person for medical writing guidance

🎯 Requirements

• Bachelor’s degree required, advanced life sciences degree preferred • A minimum of 8 years regulatory medical writing experience in the biotech/pharmaceutical industry • Experience with writing sections of INDs/BLAs/NDAs/MAAs and an understanding of CTD structure and granularity requirements • Extensive experience with clinical protocols and clinical study reports, including assembly of ICH appendices • Experience using an electronic document management system as the primary tool to complete document generation, writing, review, and approval • Knowledge of regulations relevant to medical writing • Ability to manage/work on multiple writing projects at once while balancing overlapping timelines • Ability to write clear, scientifically accurate text at a level appropriate to the audience and the project with careful attention to detail • Demonstrated ability to collaborate across multiple scientific and operational functions to achieve timely document completion • Solid understanding of statistical analysis as it pertains to clinical trials • Working knowledge of GCP, GLP, GMP, and ICH guidelines and related FDA/EMA guidance on submission elements and integrated summaries of safety and of efficacy • Excellent written and verbal communication skills • Strong project management skills with ability to manage multiple projects and execute in adherence to timelines • Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally

🏖️ Benefits

• Discretionary annual target bonus • Stock options • ESPP • 401k match • Top-notch health insurance plans for employees and their families (medical, dental, vision, basic life insurance) • 20 days of PTO • 10 paid holidays • Winter company shutdown