DDReg Pharma is a global life sciences consulting firm specializing in regulatory affairs, pharmacovigilance, and quality services. With over 15 years of experience, they help pharmaceutical, biotech, medical device, veterinary, food supplement, and cosmetic companies navigate complex regulatory landscapes. DDReg offers solutions for IPR, GMP compliance, toxicology, and utilizes technology-driven tools like RIMS and an AI-driven Regulatory Intelligence platform to expedite product registrations and ensure compliance throughout the product lifecycle. Their business model is based on providing expert consulting services and technology-enabled solutions to accelerate revenue growth for life sciences companies.
Drug SafetyGMP ComplianceIPRLife SciencesPharmacovigilanceRegTechRegulatory AffairsRegulatory Intelligenceddregpharma.com
DDReg Pharma Pvt. Ltd.
DDReg Pharma is a global life sciences consulting firm specializing in regulatory affairs, pharmacovigilance, and quality services. With over 15 years of experience, they help pharmaceutical, biotech, medical device, veterinary, food supplement, and cosmetic companies navigate complex regulatory landscapes. DDReg offers solutions for IPR, GMP compliance, toxicology, and utilizes technology-driven tools like RIMS and an AI-driven Regulatory Intelligence platform to expedite product registrations and ensure compliance throughout the product lifecycle. Their business model is based on providing expert consulting services and technology-enabled solutions to accelerate revenue growth for life sciences companies.
Drug SafetyGMP ComplianceIPRLife SciencesPharmacovigilanceRegTechRegulatory AffairsRegulatory Intelligenceddregpharma.com
HQGurgaon, IN
Team Size88
Open Jobs27
Total Funding-
Latest FundraiseUnknown
Join the Team
Team Lead-Medical Writing-Drug Safety & Reg Affairs
On-SiteGurgaon, Haryana, IN
On-Site • Gurgaon, Haryana, IN
Team Lead–Medical Writing-Drug Safety & Reg Affairs
Experience:
– 5+ Years
Location:
Gurgaon (On-site)
Job Purpose
To plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to applicable regulatory and Regulatory Guidelines
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Providing high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients.
Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
Demonstrate subject matter and therapeutic area expertise.
Effectively manage medical writing projects to deliver quality products in agreed timelines.
Collaborate with internal and external clients,
Writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports and other reports
Management of Aggregate Reports – collecting, analyzing, Authoring and developing aggregate reports (PSUR/PBRER/PADER)
Perform science review of aggregate reports produced by PV Associates
Ensure that document output and processes comply with client specifications, templates and styles guidelines
Development of Risk Management Plans (RMPs)/ Risk Evaluation & Mitigation Strategies (REMS) – data collection, analysis, Develop & Author.
Maintain awareness of current regulatory guidance, medical information techniques and technology relating to clinical / regulatory documentation
Supporting Medical safety team in ongoing review and management of safety information
Maintain & update Aggregate Report Tracker and carry out cases reconciliation on periodic basis
Supporting and enabling effective and efficient communication that results in operational excellence.
Carry out detailed searches in regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA etc for safety alerts
Mentor Associates on job skills, oversees or develops training plans or materials for safety associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel.
Education & Experience
Master’s degree in a Pharmacology/Pharmacy/Medicine
Advanced degree preferred
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’) or equivalent combination of education, training, & experience.
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
Knowledge, Skills & Abilities
Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
Strong project management skills
Excellent interpersonal skills including problem solving
Strong negotiation skill.
Excellent oral and written communication skills with strong presentation skills
Significant knowledge of global, regional, national and other document development guidelines
In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
Great judgment and decision-making skills
Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
Ability and desire to work in a team-oriented environment.
Excellent written and verbal communication skill.
Highly proficient with Microsoft Word, PowerPoint and Excel.
Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner.
Possesses a collaborative, results-driven style.
Ability to work under pressure and provide quality outputs within tight timelines
