Associate Director (M&A Integrations Quality)
Apply NowCompany: Synectics Inc.
Location: Cambridge, MA 02139
Description:
Description :
Qualifications :
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
- Mergers and Acquisitions Intergration Quality support
- Review preclinical IND submission - relevant study reports (Pharmacology, Pharmacokinetics / DMPK, Toxicology) at general level
- Review IND submission materials - modules, IB, Health Authority communications, etc.
- Baseline audit support (Quality systems, Vendor management) of a deal partner company, and Data Integrity review auditors will lead.
- Data and sample mapping at deal relevant CROs - regulated and non-regulated.
- Electronic, paper, pathology slides etc.
- Facilitate (with IT) data transfer to relevant systems.
- Study data, Electronic Notebooks, Analytical testing results, etc.
- Maintain risk logs and escalate / remediate issues as necessary
- Collaborate with relevant functions (preclinical safety etc.) to perform Source Data Verification and audit trail reviews.
- Prepare reports and summaries
Qualifications :
- 10 years experience with B.S
- 7 years experience with M.S
- 3 years experience with Ph.D.
- B.S or higher in Life Sciences, Bioengineering, Regulatory / Compliance, Biomedical
- Scientific / technical laboratory-based studies generating data and reports
- General drug discovery/ development
- Team work in matrix environment
- General understanding of Biopharma regulations (GLP, GCP, GMP)
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.