Dompé farmaceutici S.p.A.
Senior Director, Regulatory Writing
Dompé farmaceutici S.p.A., San Mateo, California, United States, 94403
Select how often (in days) to receive an alert:Senior Director, Regulatory Writing
Job Area:
R&D/MedicalJob Category:
ProfessionalsJob Site:
RemoteLocation:San Mateo, CA, USAt 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.
Increase your chances of reaching the interview stage by reading the complete job description and applying promptly.
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 budgetContribute to global regulatory strategy around clinical trial applications (CTAs), agency engagements, and regulatory filings (NDAs, BLAs, supplements)Participate and lead regulatory process improvements and initiativesOversee 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 requirementsAuthor 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 applicationsSupervise the work of contract and freelance writers and mentor junior medical writers as assignedYOU COULD BE THE PERFECT FIT IF YOU HAVE:Bachelor's of science degree (master degree or doctor degree preferred)15+ years of industry experience10+ years of direct Regulatory Writing experienceSKILLS 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 yearAt 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 FranciscoNearest Secondary Market:
Oakland
#J-18808-Ljbffr
Job Area:
R&D/MedicalJob Category:
ProfessionalsJob Site:
RemoteLocation:San Mateo, CA, USAt 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.
Increase your chances of reaching the interview stage by reading the complete job description and applying promptly.
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 budgetContribute to global regulatory strategy around clinical trial applications (CTAs), agency engagements, and regulatory filings (NDAs, BLAs, supplements)Participate and lead regulatory process improvements and initiativesOversee 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 requirementsAuthor 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 applicationsSupervise the work of contract and freelance writers and mentor junior medical writers as assignedYOU COULD BE THE PERFECT FIT IF YOU HAVE:Bachelor's of science degree (master degree or doctor degree preferred)15+ years of industry experience10+ years of direct Regulatory Writing experienceSKILLS 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 yearAt 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 FranciscoNearest Secondary Market:
Oakland
#J-18808-Ljbffr