19/12 Ashish Kadam
HR Manager at Autonomy Search

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Regulatory Writer - Pharma (10-12 yrs)

Pune Job Code: 20383

We are looking Regulatory Writer in Pune with leading pharma company.

Experience : 10+ years.

CTC : 18lpa.

Medical writers are the unifiers between scientific medical knowledge and written communication for various institutions including hospitals, academic medical centers, or pharmaceutical companies. They often follow one of two paths: scientific medical writing or non-scientific or marketing medical writing. Medical writers translate drug trials and medical study findings as well as clinical data to put into presentations to regulatory documents and for medical journal abstracts that are distributed to a professional audience.

Medical writers focus on writing the advertising copy, news releases, and educational materials for general audiences. They work alongside doctors, scientists, and other relevant health professionals to develop their content and create information that is distributed to patients including leaflets or pamphlets or websites and educational materials which include slides and posters. Medical writers need a minimum bachelor's degree or master's degree in journalism or English and experience in health and science writing as well as fluency about regulation and approval within the medical field.

- Development and review of of regulatory documents for DCGI Submissions: Rationale, Prescribing information, label, ABPI etc

- Preparation of documents for SEC meetings

- Coordination with PV Team for ADR processing

What responsibilities are common for Medical Writer jobs?

- Other activities, special projects and assignments may be given as required.

- Analyze, interpret, and distill data and other information to create documents.

- Ensure timely delivery of high quality documents to internal customers and sponsors.

- Responsible for planning and leading the writing group for assigned program.

- Provide senior review of documents and training/mentoring for others.

- Act as medical writing lead and liaison for major clients and partners.

- Provide guidance for medical writing processes, standards, and initiatives.

- Complete documents within a time period that support project needs and deadlines.

- Write, edit, review, finalize, and track CSR safety narratives.

- Provide estimated total of editorial hours needed on projects, as needed.

- Ensure all documents are produced with strict adherence to ICH guidelines and applicable federal regulations.

- Learn and continually maintain therapeutic area and product knowledge and apply to publication projects.

- Review reporting and analysis plans and provide critical input on the content and display of tables.

- Represent medical writing on cross-functional teams and task forces (related to projects, process, and standards).

- Network with senior internal and external personnel in own area of expertise.

- Ensure overall compliance with applicable departmental standard operating procedures.

- Contribute to medical writing initiatives to develop and improve processes.

- Effectively manage multiple assignments in parallel, ensuring adherence to quality, timelines and budget requirements.

- Contribute substantially to, or manage, production of interpretive guide.

- Demonstrate sound professional judgment in analyze, responding to, and resolving enquiries, issues and escalations.

What are the typical qualifications for Medical Writer jobs?

- Bachelor's Degree in science or pre-medicine and experience as a medical writer.

- Prior experience as a consultant.

- Demonstrated leadership and critical thinking skills.

- Fluency in document management systems and templating.

- Dedication to operational excellence.

- Strict attention to details and dedication to operational excellence.

- A natural collaborator and leader with decision making.

- Experience with InDesign.

- Able to gather, edit, and disseminate information.

- Sound critical thinking skills and judgment.

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