CTG CMC ASSOCIATE DIRECTOR in Morristown, New Jersey
Title: CMC ASSOCIATE DIRECTOR
Job Number: 18211946
CTG is seeking a CMC Associate Director to work at their clients site in Morristown, NJ 07962. This is a 12 month contract position that has the potential to extend longer.
Major Contributing Activities:
• The Associate Director CMC leads development of CMC strategy for Global Consumer Healthcare products. He or she is responsible for CMC support for both new and commercial products ensuring on-time development of appropriate Technical Regulatory Documents. For new products, the Associate Director is responsible for developing, gaining endorsement and executing CMC strategy to support on-time approval of new products. In this capacity, the position works closely with the development teams to ensure high quality documentation is provided and approved in accordance with project timelines.
POSITION DUTIES & RESPONSIBILITIES
• Provide leadership for the development of CMC Regulatory strategy for new product development projects.
• Work with Development Teams to ensure the on-time compilation of high quality CTD Module 3 and QOS documents.
• Define in collaboration with Regulatory Strategy the CMC requirements in order to register new products.
• Manage the dossier change requests (including manufacturing site transfers) of pharmaceutical products.
• Lead the development of technical documents for variation files
• Maintain knowledge of current industry requirements and standards for CTD Module 3 and QOS or equivalent.
• Bachelor’s degree with 10 or more years of proven experience
• Master’s degree with 6 or more years of proven experience
• Ph.D. with postdoctoral work or 4 or more years of proven experience
Skill & Competency Requirements:
• Significant experience in global CMC/Module 3 creation
• Expert in US and EU regulations with a focus on CMC
• Track record of successfully leading projects
• Experience dealing with global regulatory requirements
Experienced in the US regulatory environment (NDA, IND, ANDA)
Experience in post-approval CMC changes
Fluent in English (German and/or French speaking is a plus)
This position is compensated per hour on a W2 hourly basis (no C2C or 1099's).
Please send your word document resume to Holly Wilson at firstname.lastname@example.org. Reference job 18211946/B-3111 in the subject line.
CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.
CTG (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.
CTG's greatest asset is its people, and as such, we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Job: Documentation Management