- UpvoteDownvoteShare Job
- Suggest Revision
As the Director, Clinical Documentation and Systems Operations, reporting to the Vice-President, Clinical Development Operations, you will lead and support Trial Master File (TMF) activities with the clinical study teams and be the study document subject matter expert (SME), advising and guiding clinical study teams on management of clinical trial study documents.
$225,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Work with technical SMEs and Regulatory to review and author QC related sections of IND, IMPD, BLA/MAA and global regulatory submissions and provide support in addressing information requests. Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine's/Vertex network of external CMOs/contract labs to support company's clinical programs.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
PK, dosimetry (radiopharmaceuticals), PK/PD and M&S component of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections/radiation dosimetry of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses to Health Authority questions across the globe.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Responsible for all aspects of the software development lifecycle, including coding, integration testing, deployment, and documentation of Model Risk Management Platform. The ideal candidate has experience in SAS programming, SAS administration and Statistical analysis and experience in Model Risk Management platform.
$120,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Has knowledge of data engineering best practices (data discovery, data documentation, infrastructure development/deployment, and information security). Snowflake, Spark, Trino, Airflow, and dbt.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Pre-op Review Nurse evaluates preoperative optimization of scheduled surgical patients via telephone screening calls and by reviewing pertinent clinical documentation. Mass General Brigham is seeking a per diem / prn nurse RN ED - Emergency Department for a per diem / prn nursing job in Boston, Massachusetts.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
A first-author or co-first-author publication in cancer genomics, single-cell genomics, and/or spatial transcriptomics is required. Applicants must have a doctoral degree in computational biology, bioinformatics, genomics, computer science, biophysics, statistics, genetics, or a related field, with a solid background in both programming and cancer biology.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The village is also home of the famous landmark known as the Lower Falls Wine Company and the well-known author Sarah Fuller, who taught Helen Keller. The village is also home of the famous landmark known as the Lower Falls Wine Company and the well-known author Sarah Fuller, who taught Helen Keller.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Perform document review, study design, sample management, data review, risk assessment and trending analysis. Travel Requirements: Travel to main office and CDMOs required (20% as required) Education and Experience: B.S. or M.S. degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 8 years industry experience in analytical development and/or quality control in a pharmaceutical setting.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Join Takeda as a Scientific Director, Pathology in Cambridge, MA, where you will be responsible for active cross-functional collaboration, interdisciplinary project team participation, scientific leadership in the design and implementation of safety assessment strategies to support program advancement and decision-making, primary evaluation and peer review of pathology specimens and data, preparation and review of regulatory documentation, study reports and manuscripts.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Provide legal advice and manage a variety of complex merger and acquisition transactions or other corporate strategic transactions, including structuring, diligence, drafting and negotiating term sheets and definitive transaction documentation, and supporting closing transactions and post-closing integration.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
The Senior Manager will co-author and manage TMF documents such as TMF Plan, Index, SOPs, and other guidance documents. Demonstrated ability to understand and comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Author and review relevant PK/TK, PK/PD, and ADME sections of regulatory submission documents (e.g. investigational new drug (IND), investigator brochure (IB), clinical trial application (CTA), etc.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The incumbent also assures that deal records are set up in accordance with Portfolio Finance procedures, including presence of all deal documentation in the appropriate SharePoint folders post-closing.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The candidate will act as Subject Matter Expert (SME) for synthetic oligonucleotide solid phase synthesis and purification, author appropriate regulatory filings as required, and interface with the Quality unit to resolve quality events in a timely manner.
Full-timeExpandApply NowActive JobUpdated Yesterday
author documentation jobs in Quincy, MA
FEATURED BLOG POSTS
How to Navigate Hiring Out of State
The job market has shifted significantly in recent years. The accelerated adoption of technology has not only pushed many companies into remote working arrangements but also increased the availability of supporting tools and technologies (i.e., video conferencing and collaboration software).
Building a Candidate Pipeline Through Internships
Building a candidate pipeline through a great internship program for local college students and recent graduates at local universities is a great and cost-effective way to attract and retain top talent. By offering meaningful and impactful work experiences, regular feedback, coaching, and mentorship, you can create a positive internship experience that will make your organization a sought-after destination for future employees. This not only benefits the organization in the short-term but also in the long-term, as you'll have a pool of well-trained and experienced candidates who may be interested in full-time employment once they graduate. Furthermore, building relationships with local universities and college students can increase brand awareness and build a positive reputation for your organization in the local community.
Hiring Transparency
Transparency in hiring refers to the open and honest communication and information sharing that takes place between employers and job candidates. It encompasses all aspects of the hiring process, from posting job descriptions to providing feedback on performance during and after the interview process. In today's job market, hiring transparency has become increasingly important for both employers and candidates alike.
Recruitment strategies that are weird, but actually work
In the current candidate-driven job market, recruiters are looking for unique ways to attract talent. Some have resorted to even (dare we say it?) recruitment strategies on the border of weird and wacky. What can we learn from the unusual recruitment tactics that are being used and actually getting results? Here’s a rundown of some unique recruitment strategies that actually work.
How To Make $100K a Year – No BS Strategies & Advice
If you’re like most of us, you’d love to be wealthier. Having more money would alleviate stress. It would make it easier to pay your bills and buy nicer things. Maybe it’d allow you to spend more time with your kids and go on more vacations. You’re not alone if you wish you could somehow earn a more significant income.
7 Importances of Organizational Culture and How to Build It
The world of work has drastically changed in the past few years. Where a good salary and a nice office might have been enough to attract talent in the past, employees today expect flexibility, growth opportunities, and a healthy work environment. In fact, 77% of applicants say they’d consider a company’s culture before applying for a job.
Collaborative Recruiting: The Key to a Better Talent Acquisition Strategy
Talent acquisition is a multi-stage process where candidates undergo various application steps before getting hired. The unfortunate reality is that it is a labor-intense system, with the hiring manager and recruiter often handling all of the work on their own. Ask any one of them, and you will hear about the overabundance of applications and the demanding task of filtering through them to find the best candidates. The quality of talent suffers under the weight of all that work on one person's hands. It's not easy, but as many companies are starting to realize, there is a better way. The future of talent acquisition lies in collaborative recruiting!