Vertex Pharmaceuticals

The Science of Possibility

Associate Director, Regulatory Publishing

ComplianceComplianceContractRemoteTeam 1,001-5,000Since 1989H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

13 days ago

Salary

Not specified

Bachelor Degree9 yrs expEnglish

Job Description

• Accountable for leading publishing activities on a portfolio level • Responsible for the maintenance and lifecycle management submissions • Lead complex submission work across programs • Ensure submission content is tracked, compiled, validated, and delivered in the required format • Perform quality control (QC) reviews on vendor work • Contribute to long-term resource planning, including publishing capacity needs

Job Requirements

  • Requires Bachelor’s Degree in life sciences or technology area
  • Typically requires 9 years of Regulatory Operations/Publishing experience or equivalent combination of education and experience
  • Extensive experience in industry standard publishing software and validation systems
  • Vendor management/outsourcing experience
  • Ability to prioritize portfolio of publishing activities on selected programs
  • Ability to train and educate other team members
  • Knowledge of health authority procedures/guidances regarding electronic submissions

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work arrangements
  • Opportunity for professional development
  • Overtime pay

Related Categories

Related Job Pages

More Compliance Jobs

Full TimeRemoteTeam 10,001+H1B No Sponsor

IFM Operations & Compliance Team Lead overseeing facilities operations at JLL

North Carolina + 1 moreAll locations: North Carolina, Texas
$99K - $105K / year

Senior Compliance Officer

International Rescue Committee

The International Rescue Committee (IRC) responds to the world's worst humanitarian crises, helping to restore health, safety, education, economic wellbeing, and power to people devastated by conflict and disaster.

Compliance13 days ago
Full TimeRemote

The International Rescue Committee (IRC) responds to the world's worst humanitarian crises, helping to restore health, safety, education, economic wellbeing, and power to people devastated by conflict and disaster. Founded in 1933 at the call of Albert Einstein, the IRC is one of...

United States
$95K - $115K / year

Regulatory Affairs Associate II Contractor

Assembly Biosciences, Inc.

Assembly Bio (NASDAQ: ASMB) is an ambitious biopharmaceutical company with cutting-edge therapeutic clinical candidates capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world, and research and preclinical programs focused on the discovery of novel antivirals to treat devastating viral diseases, including HBV, hepatitis delta virus (HDV) and herpesviruses. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We set our sights high—and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions. As an equal opportunity employer, we are committed to diversity and inclusion and will not tolerate discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Information for Recruitment Agencies Assembly Bio does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Assembly Bio employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you. Location South San Francisco, California (Remote) Department 250 Regulatory & Quality Assurance Employment Type Contractor Compensation $48 - $58/hr

Compliance13 days ago
ContractRemoteTeam 51-200

The Regulatory Affairs Associate II Contractor supports regulatory activities across Assembly Biosciences’ development programs, including regulatory operations, document management, and meaningful contributions to regulatory strategy for assigned projects. This role is primari...

United States
$48 - $58 / hour

Senior Associate Global Policy and Advocacy Specialist

Dexcom

Empowering people to take control of health

Compliance13 days ago
Full TimeRemoteTeam 10,001+Since 1999H1B Sponsor

You will champion meaningful engagement with people living with Diabetes, healthcare provider organizations and patient advocacy organizations, building and managing strategic, compliant relationships with national and community-based patient advocacy organizations. Represent the...

United States
$71.6K - $119K / year