Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Nonclinical Regulatory Writer for DMPK/BA Submissions

TechDigital Group

Must have skills Dot Net Preferred skills Agile development Methodology Detailed Job Description 12+ years of hands-on experience as .NET developer Develop software solutions using the .NET framework and related technologies. Collaborate with business analysts and project managers to understand application requirements. Write efficient, reusable, scalable code in C# and ASP.NET technology. Conduct code reviews, unit testing, and debugging to ensure software functionality. Integrate software components with third-party systems and services. Provide ongoing support and maintenance for existing software applications. Stay informed about advancements in the .NET framework and related technologies. Strong understanding of the .NET framework, C#, and object-oriented programming. Proficiency in database design and SQL. Experience with web development technologies, including ASP.NET, MVC, and API. Detail-oriented with a focus on delivering high-quality and efficient software solutions. Efficient communication skills and the ability to work collaboratively within a team. Strong knowledge of software development best practices and design patterns. Professional certification in .NET development or related technologies. Experience with front-end technologies such as HTML, CSS, and JavaScript. Familiarity with software version control systems (e.g., Git). Experience with Agile or Scrum development methodologies. #J-18808-Ljbffr TechDigital Group

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Nonclinical Regulatory Writer for DMPK/BA Submissions in New Brunswick, NJ vacancy
  •  ...staffing solutions firm in New Jersey is seeking a professional to create documents necessary for clinical data management and regulatory submissions. The ideal candidate will possess excellent scientific writing and analytical skills, managing deadlines and ensuring... 
    Senior
    Regulatory

    Artech Information System LLC

    Peapack, NJ
    4 days ago
  • $75k - $112.5k

     ...care for patients around the world. As a Senior Medical Writer , you will write medical content for...  ..., as necessary Attend medical, legal, regulatory review meetings and participate, as necessary...  ...client meetings Required Education BA/BS in life sciences BA/BS in English... 
    Senior
    Regulatory

    Precision Medicine Group

    Peapack, NJ
    16 hours ago
  • $190.8k - $300.3k

    Job DescriptionThe Nonclinical Drug Safety (NDS) Therapeutic Area Leader (TAL) is a senior scientific leader responsible for advancing...  ..., a deep understanding of regulatory expectations for immunology...  ...assessments, and regulatory submissions that support global clinical... 
    Senior
    Regulatory
    Full time
    For contractors
    Local area
    Flexible hours

    Merck Sharp & Dohme (MSD)

    Rahway, NJ
    8 days ago
  • Merck & Co., Inc. in Rahway, NJ seeks an experienced Clinical and Regulatory Medical Writer to prepare regulatory and public-facing documents in alignment with regulatory requirements and health-literacy standards. You will lead cross-functional teams, manage multiple projects... 
    Senior
    Regulatory

    MSD

    Rahway, NJ
    16 hours ago
  • Precision Medicine Group is seeking a Senior Medical Writer to develop medically accurate content for our pharmaceutical clients, working with...  ...is achieved and content is aligned with scientific and regulatory standards. You will mentor junior staff, conduct literature... 
    Senior
    Regulatory

    Precision Medicine Group

    Peapack, NJ
    16 hours ago
  • $43 per hour

     ...Solutions has a client that is immediately hiring for a Regulatory- Technical writer. Position type: Full-time- Contract Duration: 12 Months...  ...strategy for clinical and life-cycle CMC regulatory submissions and responses the health authority questions based on high... 
    Regulatory
    Hourly pay
    Full time
    Contract work
    Temporary work
    Work experience placement
    Work at office
    Immediate start
    Worldwide
    Flexible hours

    American Cybersystems

    New Brunswick, NJ
    3 days ago
  • $117k - $184.2k

    Job Description The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trial Operations (GCTO) creates...  ...orientation of new team members or mentoring less experienced writers. May manage direct reports, including workload, professional... 
    Senior
    Regulatory
    For contractors
    Work at office
    Local area
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    MSD

    Rahway, NJ
    16 hours ago
  • $38 - $41.96 per hour

    A leading biopharma company in New Jersey is seeking a Technical Writer and Document Specialist to support regulatory submissions for a late-stage clinical cell therapy program. Responsibilities include co-authoring scientific content, managing submission logistics, and... 
    Regulatory
    Hourly pay
    Contract work

    Bristol Myers Squibb

    Milltown, NJ
    3 days ago
  • $100k - $130k

    Job Description Must Have Technical/Functional Skills Medical writing, Regulatory writing, Content strategy, Copy development, Brand messaging, Healthcare communication Roles & Responsibilities Medical writing, Regulatory writing, Content strategy, Copy development, Brand... 
    Senior
    Regulatory

    Tata Consultancy Services

    Woodbridge, NJ
    2 days ago
  • $38 - $41.96 per hour

    The Technical Writer and Document Specialist (TW/DS) will sit within...  ...documents) to support the regulatory strategy for a late‑stage clinical...  ...to deliver on timelines for submissions. The position interfaces with...  ...’ experience (4-7 years for senior level). Familiarity and... 
    Regulatory
    Hourly pay
    Contract work
    Temporary work
    Work at office
    Local area

    Bristol Myers Squibb

    Milltown, NJ
    3 days ago
  • $117k - $184.2k

     ...The Clinical and Regulatory Strategic Communications (CRSC) department within Global...  ...members or mentoring less experienced writers. May manage direct reports, including...  ...Compliance, Regulatory Documents, Regulatory Submissions, Technology Platforms Preferred... 
    Senior
    Regulatory
    For contractors
    Work at office
    Local area

    Merck Sharp & Dohme Corp

    Rahway, NJ
    4 days ago
  •  ...coordinate programming, and collaborate with investigators, sponsors, data managers, and regulatory experts under faculty supervision. The role focuses on study design, regulatory submissions, and scientific publications, with a path for ongoing professional development... 
    Senior
    Regulatory

    Rutgers University

    New Brunswick, NJ
    1 day ago
  • $50k - $70k

     ...Customs Entry Writer Location: Edison, NJ As Customs Entry Writer, you will ensure...  ...entries, ensuring compliance with regulatory requirements and facilitating the efficient...  ...applicable laws and regulations prior to entry submission to U.S Customs and Partner Government... 
    Regulatory
    Work at office

    DHL

    Edison, NJ
    4 days ago
  • $190.8k - $300.3k

     ...Senior Principal Scientist leading nonclinical drug safety strategy for immunology programs at Merck. Responsible for overseeing development progression, regulatory submissions, and post-marketing support while mentoring scientists and influencing cross-functional partnerships... 
    Senior
    Regulatory

    Merck

    Rahway, NJ
    a month ago
  • $178k - $307.05k

     ...are searching for the best talent for a Senior Director, Business Development, Immunology...  ...therapeutic areas, as needed. Qualifications BA/BS minimum requirement; MBA preferred...  ...Policy Development, Professional Ethics, Regulatory Compliance, Strategic Change, Succession... 
    Senior
    Regulatory
    Local area
    Immediate start
    Worldwide

    6085-Janssen Global Services, LLC Legal Entity

    New Brunswick, NJ
    4 days ago
  • $125k - $140k

     ...meets dsm-firmenich standards, ISO standards, and all relevant regulatory requirements. Develop and maintain a thorough...  ...individual, we’d love to hear from you. We’re not accepting agency submissions or proposals involving fees or commissions for this role.... 
    Senior
    Regulatory
    Full time
    Local area

    dsm-firmenich

    Somerset, NJ
    3 days ago
  • $210.4k - $331.1k

     ...Oncology (QP2 Oncology) team as Senior Director, Group Leader. QP2...  ...ML) for key development and regulatory decisions.This role provides...  ...appropriate translation of nonclinical findings into clinical...  ...CSRs, CTD modules, NDA/BLA submissions)Ensure delivery of high-quality... 
    Senior
    Regulatory
    Full time
    For contractors
    Local area
    Flexible hours

    Merck Sharp & Dohme (MSD)

    Rahway, NJ
    5 days ago
  • $170k - $190k

    The Senior Clinical Trial Drug Supply Manager is a critical position within the clinical...  ...the execution of clinical trials and regulatory submissions. This role will be responsible for...  ...Supply ChainEducation:Bachelors Degree (BA/BS) Life Sciences, Pharmaceutical Sciences... 
    Senior
    Regulatory
    Temporary work
    Work at office
    Flexible hours

    Amneal Pharmaceuticals

    Bridgewater, NJ
    7 days ago
  • $142.4k - $224.1k

     ...tools to enable the discovery, development, regulatory approval, manufacturing, and marketing...  ...Principal Statistical Programmer, Submission Data Standards Quality Management (SDS QM...  ...teams.Education and Minimum Requirement:BA/BS in Computer Science, Statistics, Applied... 
    Regulatory
    Full time
    For contractors
    Local area
    Worldwide
    Flexible hours

    Merck Sharp & Dohme (MSD)

    Rahway, NJ
    6 days ago
  • $125k - $140k

     ...meets dsm-firmenich standards, ISO standards, and all relevant regulatory requirements. Develop and maintain a thorough...  ...individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.... 
    Senior
    Regulatory
    Local area

    dsm-firmenich

    Somerset, NJ
    3 days ago
  •  ...regional job sites. You will promote a proactive safety culture among field crews and ensure compliance with company policies and regulatory requirements. Responsibilities include leading trainings, site visits, incident investigations, and coordinating safety plans... 
    Senior
    Regulatory

    Consigli Construction

    New Brunswick, NJ
    5 days ago
  •  ...physical, pharmacological, investigator brochures, clinical study reports, environmental, and other scientific data, as well as regulatory information, related to Client materials. Perform routine categorizations and calculations. Prepare toxicological classification... 
    Regulatory

    TechDigital Group

    New Brunswick, NJ
    2 days ago
  • $92.32k - $126.94k

     ...investigators and Terumo. Will be responsible for site training, regulatory document collection, tracking enrollment, and ensuring case...  ...databases as needed. Qualifications/ Background ExperiencesBS / BA or higher in a clinical or scientific area required; RN is preferred... 
    Senior
    Regulatory
    Temporary work
    Work experience placement
    Interim role
    Worldwide

    Terumo Medical Corporation

    Somerset, NJ
    4 days ago
  • $122k - $212.75k

     ...We are searching for the best talent for Senior Legal Counsel, Innovative Medicine...  ...applications will be considered as a single submission. About Innovative Medicine Our expertise...  ...Process Improvements, Program Management, Regulatory Compliance, Relationship Building,... 
    Senior
    Regulatory
    Contract work
    Work at office
    Local area
    Immediate start

    Johnson & Johnson Co.

    New Brunswick, NJ
    2 days ago
  • $117k - $184.2k

     ...Merck seeks a senior medical writer to develop clinical regulatory and public-facing documents within the Clinical and Regulatory Strategic Communications department. The role requires independent preparation of protocols, study reports, informed consent forms, and plain... 
    Senior
    Regulatory
    Work at office

    Merck

    Rahway, NJ
    3 days ago
  •  ...Associate Director or Director, Advertising & Promotions to oversee regulatory review of promotional materials. The role reports to the Head...  ...incumbent provides strategic regulatory guidance, manages FDA submission requirements, and leads reviews to ensure accuracy, balance,... 
    Senior
    Regulatory

    Tris Pharma

    Franklin Park, NJ
    2 days ago
  •  ...or Director of Advertising & Promotions to join the Regulatory Affairs team. The role provides senior regulatory oversight for review and approval of promotional...  ...promotional reviews, advise on substantiation for claims, manage FDA submission #J-18808-Ljbffr Tris Pharma, Inc
    Senior
    Regulatory

    Tris Pharma, Inc

    Franklin Park, NJ
    16 hours ago
  • Johnson & Johnson is seeking a Senior Manager, Trade Controls Southern Border based in New Brunswick, NJ. You will lead the strategy...  ...Medical Technology, working with cross-functional partners to ensure regulatory compliance. The role requires 10+ years in U.S. import... 
    Senior
    Regulatory

    Johnson & Johnson

    New Brunswick, NJ
    2 days ago
  • Job-ID32132087Reference26-00454 Job Description: The Senior Manager in Statistics responsible for perform statistical activities in...  ...study report and statistical activities in drug in-licensing, regulatory filings and marketing. Responsibilities: Review protocol, understand... 
    Senior
    Regulatory

    Katalyst Healthcares & Life Sciences

    New Brunswick, NJ
    3 days ago
  •  ...Senior AccountantLocation: Piscataway, NJ (Onsite)Position SummaryWe are seeking a hands-on Senior Accountant to oversee full-cycle...  ...US GAAP, payroll tax requirements, workers' compensation, and regulatory filings.Assist with year-end audits, tax preparation, and insurance... 
    Senior
    Regulatory
    For contractors

    First Tek

    Piscataway, NJ
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Nonclinical Regulatory Writer for DMPK/BA Submissions. Be the first to apply!