Scientific Writing and Reporting Scientist - Hyderabad

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Pharmacokinetics & Pharmacometrics Job Category: Scientific/Technology All Job Posting Locations: Hyderabad, Andhra Pradesh, India Job Description: Scientific Writing and Reporting Scientist - Hyderabad Objective of Position: The Clinical Pharmacology & Pharmacometrics (CPP) Scientific Writing & Reporting (SWR) Scientist is responsible for writing documents, coordinating reviews and document finalization, performing document quality control (QC) and managing (e.g. timelines, resources, and metrics) of documents related to  Clinical Pharmacology trials. They assist in the preparation (in collaboration with the Clinical Pharmacology Leader)of the following activities in support of Clinical Pharmacology Phase 1 studies: Protocol authoring and CSR writing. In addition, they may create and provide summaries of performed Clinical Pharmacology studies for inclusion in CTD documents. Additional responsibilities include QC review of documents. This function liaises closely with stakeholders to ensure timely & high quality delivery of documents, in line with internal standards and processes while adhering to applicable guidelines and regulations. Main Accountabilities:   Authors, coordinates, and facilitates timely reviews and approval ofPhase I clinical and regulatory documents such as, but not limited to, CSRs, protocols, and submission summary documents under close supervision. Attends cross-functional (eg, with clinical team) document planning and review meetings. Interacting with CP TA Project Leads, CP Leader, PK Scientists, and cross-functional colleagues on document content and champion writing processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and the study team, as needed. Able to function as the Phase I writer on compounds across all therapeutic areas under supervision. Is primary point of contact for assigned writing activities for the cross-functional team. Performs QC of protocols and CSRs of Phase I clinical and regulatory documents developed within the department. Learns and adheres to SOPs, templates, internal standards, and regulatory guidelines and regulations. May participate in process working groups for writing processes within CPP. Complete all time reporting and training as required in relevant company systems Minimum Qualifications / Experience A university/college degree in scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. Minimum Technical Knowledge and Skills: Proficiency in written and spoken English is essential, along with the ability to collaborate with global teams and stakeholders across time zones, requiring some flexibility in your daily routine. Good technical skills with MS Word. Desire to learn how to interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in various document types under supervision. Learns and applies knowledge of regulatory guidance documents such as ICH