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
- ...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...SeniorRegulatory
$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...SeniorRegulatory$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...SeniorRegulatoryFull timeFor contractorsLocal areaFlexible hours- 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...SeniorRegulatory
- 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...SeniorRegulatory
$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...RegulatoryHourly payFull timeContract workTemporary workWork experience placementWork at officeImmediate startWorldwideFlexible hours$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...SeniorRegulatoryFor contractorsWork at officeLocal areaRelocationVisa sponsorshipFlexible hoursShift work$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...RegulatoryHourly payContract work$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...SeniorRegulatory$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...RegulatoryHourly payContract workTemporary workWork at officeLocal area$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...SeniorRegulatoryFor contractorsWork at officeLocal area- ...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...SeniorRegulatory
$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...RegulatoryWork at office$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...SeniorRegulatory$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...SeniorRegulatoryLocal areaImmediate startWorldwide$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....SeniorRegulatoryFull timeLocal area$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...SeniorRegulatoryFull timeFor contractorsLocal areaFlexible hours$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...SeniorRegulatoryTemporary workWork at officeFlexible hours$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...RegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours$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....SeniorRegulatoryLocal area- ...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...SeniorRegulatory
- ...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
$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...SeniorRegulatoryTemporary workWork experience placementInterim roleWorldwide$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,...SeniorRegulatoryContract workWork at officeLocal areaImmediate start$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...SeniorRegulatoryWork at office- ...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,...SeniorRegulatory
- ...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, IncSeniorRegulatory
- 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...SeniorRegulatory
- 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...SeniorRegulatory
- ...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...SeniorRegulatoryFor contractors
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