Overview

Novumgen – The group of Entrepreneurs and Scientists.

Novumgen is a diverse, integrated specialty pharmaceutical and biological company focused on investing, developing, manufacturing, and supplying innovative products that provide benefits to patients and prescribers. We are focused on delivering life-changing medicines that contribute safety and value to patients, healthcare institutions, and prescribers across the globe. As a company, Novumgen has made a lasting commitment to patient safety, introducing new products to our portfolio while maintaining unrivalled quality and exceptional service to the pharmaceutical industry

We are currently looking to recruit a Human Resources Advisor, with experience in the UK to cover a period of maternity leave, with the view to become permanent, dependent on company growth. The role of the Human Resources Advisor is to give counsel to the company regarding our human resource policies and procedures. The main duties will include offering guidance on employee recruitment and retention, evaluating employee performance, and maintaining employee relations

Candidate Duties

• Management of eCTD module writing such as M 2.4, 2.5, 2.6, 2.7 .
• Handling of Scientific writing team and give training of different writing methodology.
• Hands on experience of Clinical study such as BA/BE, PD, End point study etc.
• Responsible for communication and coordination with inter-intra department & regulatory agencies for scientific discussion.
• Preparation & review of PDE report in timely manner.
• Having expertise in narrative creation for scientific documents, medical brochure & Healthcare professional brochure.
• In-depth knowledge of benefit-risk evaluation writeup and methodology of benefit-risk analysis.
• Response to regulatory agency query in stipulated timeline.

Candidate Qualification

• M.Pharm (Pharmacology)

Candidate Requirements

• 6 to 8 Years of experience in eCTD module 2 writing.