Opening to work as Regulatory C.M.C Scientific Writer in Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.

Post: Regulatory C.M.C Scientific Writer-1418259

Job Description
1. Regulatory CMC Scientific writer is to be responsible for authoring regulatory filings as necessary for marketed vaccines/ biologicals.
2. This position requires in-depth knowledge of biological products (specifically vaccines) as well as hands-on submission authoring / technical writing experience.
3. Specific focus is on writing the Chemistry, Manufacturing, and Controls (CMC) sections of the CTD module.

Duties and responsibilities:
· Liaises with onsite (global) Regulatory Affairs Associates, or Client site colleagues, to obtain manufacturing site documents for use in authoring global post-approval CMC submissions
· Plans and authors regulatory submissions using a client template(s), and using the clients’ systems
· Submissions would include: Module 3, Module 2.3, Variations, New Biological License Applications (BLAs) for Rest of the World (ROW) markets
· Attend meetings, as necessary, to support submission authoring projects

Skills and Experience required:
· In-depth knowledge and experience of regulations pertaining to biologics, specifically vaccines
· Demonstrated strong writing and communication skills
· Strong attention to detail, ability to multi-task

Education & experience:
· Primary (graduate/post graduate) degree in Pharmacy, Biotechnology, Chemistry or Life Science
· 2+ years experience in biologics/vaccines CMC regulatory affairs, experience in vaccines strongly preferred

Qualifications
1. Regulatory CMC Scientific writer is to be responsible for authoring regulatory filings as necessary for marketed vaccines/ biologicals.
2. This position requires in-depth knowledge of biological products (specifically vaccines) as well as hands-on submission authoring / technical writing experience.
3. Specific focus is on writing the Chemistry, Manufacturing, and Controls (CMC) sections of the CTD module.

Additional Information:
Experience: 2+ years
Location: Karnataka-Bangalore
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
End Date: 20^th April, 2015