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Annexon
South San Francisco, CA, United States
Position Summary The Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented and collaborative team across our Research/Pre-Clinical, CMC, Regulatory, Clinical, and Quality organizations to author and drive development of key
Job Source: AnnexonAnnexon, Inc.
Brisbane, CA, United States
Director / Senior Director, Medical Writing Work Location Corporate Headquarters (South San Francisco, CA) - Hybrid Position Summary The Director / Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented and collaborative tea
Job Source: Annexon, Inc.Mirum Pharmaceuticals
Foster City, CA, United States
Are you within a commutable distance to Foster City and willing to commit to a hybrid work schedule with being on site 2 days per week? * -- If you are not local to the Foster City area, are you willing to relocate? * Yes No I am local Are you currently authorized to work for any employer in the US without visa support? * -- By participating in
Job Source: Mirum PharmaceuticalsAnnexon
Brisbane, CA, United States
Director / Senior Director, Medical Writing Work Location Position Summary The Director / Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented and collaborative team across our Research/Pre-Clinical, CMC, Regulatory, C
Job Source: AnnexonAbdera Therapeutics
South San Francisco, CA, United States
Salary Range : US$ 200K - $270K Who we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes
Job Source: Abdera TherapeuticsAbdera Therapeutics
South San Francisco, CA, United States
Salary Range : US$ 200K - $270K Who we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to s
Job Source: Abdera TherapeuticsAbdera Therapeutics
San Francisco, CA, United States
Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing
Job Source: Abdera TherapeuticsKyverna Therapeutics, Inc.
Emeryville, CA, United States
Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory
Job Source: Kyverna Therapeutics, Inc.Oakland, CA, United States
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At Dompé, our success is rooted in our team and our history. We are a private, rapidly growing global biopharmaceutical company. Founded in Milan, Italy, we have a 130-year legacy of medical innovation. Dompé’s rich history has greatly influenced its priorities today: to innovate for the benefit of patients facing both everyday wellness needs and rare conditions. Dompé operates in two strategic areas in select markets around the world: Primary Care, which includes prescription and over-the-counter products; and Biotechnology and Rare Disease, which recently expanded into the United States.
Today Dompé has 900 employees worldwide and we are excited to be rapidly scaling in the United States. Our R&D hub is currently based in Boston, and the commercial organization is housed in the San Francisco Bay Area.
Head Regulatory Writing department overseeing staff, vendors, and budget
Contribute to global regulatory strategy around clinical trial applications (CTAs), agency engagements, and regulatory filings (NDAs, BLAs, supplements)
Participate and lead regulatory process improvements and initiatives
Oversee the implementation and training standards for standard operating procedures (SOP’s), guidance documents, and work instructions to ensure compliance with regulatory and company standards and requirements
Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms,, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Plans (PIP, PSP) and requests for orphan designation.
Supervise staff or vendors to lead regulatory writing activities for complex product submissions, including new and supplemental drug applications / biologics license applications
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
YOU COULD BE THE PERFECT FIT IF YOU HAVE:
Bachelor's of science degree (master degree or doctor degree preferred)
15+ years of industry experience
10+ years of direct Regulatory Writing experience
SKILLS YOU’LL NEED FOR SUCCESS: TECHNICAL
• Excellent written/oral communication skills and attention to detail
• Strong knowledge of ICH and global (EU and US) regulation and HA requirements on submission documents
• Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds
• Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment
• Proficient with word processing systems, document management systems and Regulatory Information Management (RIM) systems
• Proficient time and project management skills
• Direct experience with creation and submission of original new drug (NDA) and or biologic (BLA)
Base Salary: $220,000 - $280,000 a year
At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Nearest Major Market:
San Francisco
Nearest Secondary Market:
Oakland
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Email Alert for Senior Director, Regulatory Writing jobs in Oakland, CA, United States
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