Asst. Manager Medical Writing DDReg Pharma Pvt. Ltd.

3.0 - 7.0 years

0 Lacs

haryana

On-site

As a Medical-Regulatory Writer Assistant Manager, you will be responsible for planning and managing Medico-Regulatory Writing in compliance with applicable Regulatory Guidelines. Your duties will include providing high-quality medical and scientific writing, offering technical consultation and advice on strategy and regulations, demonstrating subject matter expertise, managing writing projects effectively to meet deadlines, collaborating with internal and external clients, and writing various types of reports such as CTD Modules, Safety Reports, and Aggregate Reports. You will also be required to conduct science reviews of aggregate reports, ensure document compliance with client specifications, attend project meetings, stay updated on regulatory guidance, maintain Aggregate Report Tracker, perform detailed searches on regulatory agency websites, mentor associates, and provide effective communication that leads to operational excellence. To qualify for this role, you should have a Master's degree in Pharmacology/Pharmacy/Medicine with at least 5 years of experience. An advanced degree is preferred, along with previous experience in the pharmaceutical/CRO industry. Additional qualifications in medical writing (AMWA, EMWA, RAC) would be advantageous. You should possess excellent data interpretation and medical writing skills, strong project management abilities, interpersonal and negotiation skills, and exceptional oral and written communication skills. Knowledge of global, regional, and national document development guidelines, along with proficiency in Microsoft Word, PowerPoint, and Excel, is essential. You should be able to work well in a team, handle pressure, and deliver quality work within tight timelines. Occasionally, you may need to work in different time zones. This position does not have any direct reports and is based in Gurgaon. If you meet the qualifications and possess the required skills and abilities, we invite you to apply for this challenging and rewarding role in the medical-regulatory writing field.,

Posted 2 days ago

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The cleaned title is Assistant Manager Medical Writing DDReg Pharma Pvt. Ltd.

3.0 - 7.0 years

0 Lacs

haryana

On-site

The Medical-Regulatory Writer Assistant Manager will be responsible for planning and managing Medico-Regulatory Writing for Regulatory compliance in accordance with applicable Regulatory Guidelines. You will be tasked with providing high-quality medical and scientific writing services, from planning and coordinating literature searches to delivering final drafts to both internal and external clients. Your role will also involve offering technical consultation, substantive advice on strategy, regulations, and industry best practices, and demonstrating expertise in subject matter and therapeutic areas. In addition, you will need to effectively manage medical writing projects to ensure the delivery of quality products within agreed timelines. Collaboration with internal and external clients will be essential, along with tasks such as writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports, and other relevant documents. You will also be responsible for conducting science reviews of aggregate reports produced by PV Associates and ensuring that all document outputs and processes align with client specifications, templates, and style guidelines. Furthermore, the role requires attending project initiation meetings, maintaining awareness of current regulatory guidance and medical information techniques, updating Aggregate Report Tracker, carrying out cases reconciliation periodically, and conducting detailed searches on regulatory agency websites for safety alerts. Mentoring Associates, overseeing training plans, and enhancing the skills of existing team members will also be part of your responsibilities. The ideal candidate should hold a Master's degree in Pharmacology/Pharmacy/Medicine with at least 5 years of experience, although an advanced degree is preferred. Previous experience in the pharmaceutical/CRO industry is advantageous, along with additional qualifications in medical writing such as AMWA, EMWA, or RAC. Strong data interpretation, medical writing, and project management skills are essential, as well as excellent interpersonal, negotiation, oral and written communication skills. Proficiency in Microsoft Word, PowerPoint, and Excel, as well as the ability to work effectively in a team-oriented environment, are also required. This position may occasionally require working in different time zones as needed. There are no direct reports for this role, and the location will be in Gurgaon.,

Posted 1 week ago

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Faculty - Drug Regulatory Affairs - Visiting Faculty - Remote Cliniminds

10 - 15 years

15 - 25 Lacs

Noida

Remote

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

Posted 2 months ago

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