Medical Writer / Regulatory in Princeton, New Jersey

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Our client, among the major pharmaceutical firms situated in Princeton, NJ, is seeking a Medical Researcher for a long-term (6+ month) agreement task.
Shown sturdy writing abilities and encounter in writing and handling the production of scientific documents (e.g. safety-risk related files, clinical documents) as well as taking care of the manufacturing of critical safety-risk related papers.
Demonstrated understanding of the international pharmaceutical medicine advancement process.
Focus to specific along with shown analytical and theoretical capabilities and the capacity to get to independent and reasoned verdicts.
Demonstrated ability to manage timelines and quality of work making use of sturdy organizational, communication, assistance, and interpersonal abilities in a cross-functional group.
Capability to strategy and arrange workload including a selection of major jobs and conclusion days.
Shown capacity to complete a number of, simultaneous tasks with marginal direction.
Accepts individual duty for offering top quality files which sustain exterior and interior consumer necessities and gets rid of unpredicted obstacles to obtain this goal.
Work with and author safety-risk associated papers consisting of critical safety-risk related documents needed for governing submissions, making sure the sychronisation and combination of information from cross practical group authors.
Take part in appropriate sub-teams of the MST and make sure effective planning and management of timelines for all components of assigned records.
Collaborate with others to fix problems, mistakes, or inconsistencies with pertinent business partner to make sure timely completion and excellent quality of designated documents.
Testimonial and edit files as called for. Use version documents and job within the PRISM/CARA doc base and collaborates the collection of the document.
Good documentation principles (organization, quality, scientific specifications) consistency between text and tabular presentations or visual screens in conformity with documentation requirements and around the world governing needs.
Handles the review procedure with the outsource professionals and/or go across practical team writers, on a recurring basis, deals with concerns, errors, or disparities with relevant employee to ensure prompt completion and extremely high quality of appointed documents.
Maintains source records for QC.
NEEDS.
PhD/MD/PharmD in a pertinent scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical governing paperwork, or equivalent, and mutual understanding of needs for regulative submission records.
Furthermore:.
 (i) showed strong writing skills as evidenced by top quality filling in pharmaceutical regulative documentation and/or publications in peer-reviewed diaries,.
(ii) great understanding of global pharmaceutical drug advancement and needs for entry of regulatory files to global health authorities,.
(iii) showed capability to take care of timelines and quality of work utilizing sturdy organizational, interaction, assistance and interpersonal abilities in a cross-functional group,.
(iv) functioning understanding of a paper administration system and basic understanding of paper publishing process,.
(v) assessed and translated complex information from a wide range of scientific self-controls.
Coordinate and writer regulative papers (e.g. stage I/II scientific research study records, Investigators Sales brochure) ensuring the coordination and combination of the scientific, regulatory and health care input from advancement business partner.
When delegated as Lead Researcher, capacity to lead other researchers, including creating strategies / strategies and taking care of tasks, in order to complete a number of files for governing submissions.
Show proficiency of complex writing tasks (e.g., Stage III CSRs, CSS, CSE, Ambient Plans, and so on) throughout therapeutic locations or numerous jobs.
Join appropriate declaring sub-team(s) and make certain efficient preparation and management of timelines for all components of designated records.
Lead or co-lead (with Doc Lead) teams to define content and data shows for CSR shells and prototypes.
Able to collaborate with project group to react to health authority concerns, requests, and so on
. Provide department management with adequate details to assist evaluate resource requirements.
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