Clinical Pharmacology & Pharmacometrics Scientific Writing & Reporting Principal Scientist
Join to apply for the Clinical Pharmacology & Pharmacometrics Scientific Writing & Reporting Principal Scientist role at Johnson & Johnson Innovative Medicine
Clinical Pharmacology & Pharmacometrics Scientific Writing & Reporting Principal Scientist
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Join to apply for the Clinical Pharmacology & Pharmacometrics Scientific Writing & Reporting Principal Scientist role at Johnson & Johnson Innovative Medicine
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com
Job Function
Discovery & Pre-Clinical/Clinical Development
Job Sub Function
Pharmacokinetics & Pharmacometrics
Job Category
Scientific/Technology
All Job Posting Locations:
Beerse, Antwerp, Belgium
Job Description
The Clinical Pharmacology & Pharmacometrics (CPP) Scientific Writing & Reporting Principal Scientist is responsible for writing documents, coordinating reviews, performing document quality control (QC) and managing (e.g. timelines, resources, and metrics) CPP deliverables including but not limited to shell drafts of pharmacometric analysis and data transfer plans, pharmacometric memos and reports, and other types of CPP deliverables. This role will also collaborate with cross functional teams to streamline the coordination of consistent document upload within the required regulatory document management system. Driving effective contributions to process enhancements including automation are key to this role. This function liaises closely with stakeholders to ensure timely & high quality delivery of documents, in line with applicable guidelines and regulations.
Main Accountabilities
* Write and coordinate, shell draft, review, and/or final versions of CPP owned documents, including but not limited to, analysis and data transfer plans based on study protocols, and various types of reports related to pharmacometrics and other types of analyses.
* Facilitate timely reviews and approval of written documents.
* Perform document QC of CPP deliverables and manage the review process, including timely documentation within the applicable document QC checklist, comment resolution follow up, lead document QC meeting in close collaboration with other colleagues within CPP, as required.
* Oversee the central planning of document writing & QC of CPP deliverables, track project progress and support of metric reporting.
* Actively contribute to process improvements in support of interactions between Clinical Pharmacology & Pharmacometrics and cross-department stakeholders.
* Support the development and maintenance of CPP reporting templates, analysis plans, summary documents, data transfer plans, as required in close partnership with the document service management group.
* Lead/contribute to process improvement and automation initiatives. Revise, update and create (if needed) SOPs, Job aids, templates, training materials for CPP internal processes and other cross departmental processes as needs arise.
* Maintains and applies knowledge of industry, company, and regulatory guidelines.
Other Accountabilities & Tasks
* May mentor new or junior colleagues of the CPP department, related to document processing, formatting, planning, processes and document review .
* Carry out functional responsibilities in accordance with applicable SOPs and Regulatory requirements.
Minimum Qualifications / Experience
* Bachelor’s degree or higher is required with 4+ years of pharmaceutical/scientific experience and at least 2 years of clinical writing experience.
Minimum Technical Knowledge And Skills
* Good oral and written communication skills, including ability to write and review cohesive reports and related documentations.
* Good technical skills with MS Word.
* Knowledge on regulatory systems such as RIMDocs.
* General understanding of overall process of drug development and clinical data is a plus.
* Attention to detail, proficient in time and project management
* Adding value to the organization assuming responsibility and accountability for successfully completing assignments or tasks.
* Demonstrate learning agility.
* Builds and maintains solid and productive relationships with cross-functional team members.
Other Requirements
* Estimated both domestic and international travel of about 5% of time.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Health Care Provider
* Industries
Pharmaceutical Manufacturing
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