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Sr Supervisor, Pharmacometrics. Job in Cambridge, Massachusetts, United States in Biogen. Nelest.com
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Sr Supervisor, Pharmacometrics

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Job ID:

23128

Location:

Cambridge, MA 

Job function:

Research & Development
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Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Sr Supervisor, Pharmacometrics

Job Description:

Provides small molecule bioanalysis oversight, quality control, and data management to ensure successful conduct of Quantitative Pharmacology trials and support of document management for all programs in the development pipeline.
Essential Functions:
Bioassay Support:

- Serves as department liaison for all small molecule bioanalytical activities.

- Oversees development, validation, and trouble-shooting support for assays.

- Manages appropriation of reference standards.

- Responsible for all other bioassay activities related to department responsibilities.
QC Support:

- Manages the QC workload to perform data checking of Master Study Files to department reports (IB, Annual Reports, Clinical Study Reports, Dept. Summary Reports)

- Ensures compliance with Standard Operating Procedures (SOP)

- Maintains Study Number Master List

- Acts as department QA at CRO
Data Management:

- Maintains & requests IT Permission changes on pertinent files/folders as necessary

- Software Administrator (BPO)

- On-site archivist of files and historical products

*LI-RD2

Job Requirements:

QualificationsPossesses a strong understanding of the science being conducted with emphasis on bioanalysis, also knowledgeable on protocol specifications, data transfer, PK/PD analysis, and reporting. Familiar with QC procedures in drug development. General understanding of regulatory standards with at least 5 years of experience in the Pharmaceutical Industry.
- Exceptional planning & organizational skills.
- Exceptional attention to detail & timelines.
- Excellent communication & interpersonal skills.
- Ability to understand the design of experiments and the analysis used to review final reports.
- Able to assess and manage a diverse, time-sensitive workload. EducationBS/MS degree in a scientific discipline. Incumbent typically has 5+ years in drug development R&D within an industry setting. Has significant expertise in small molecule bioanalysis and is familiar with QC procedures. Excellent communication skills. About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

Zip Code:

02142

Company Info
Biogen

Cambridge, MA, United States

Phone: +1 781-464-3260, +1 781-464-3260
Web Site: www.biogene.com

Company Profile

Company Info


Biogen
Cambridge, MA, United States
Phone: +1 781-464-3260, +1 781-464-3260
Web Site: www.biogene.com

Sr Supervisor, Pharmacometrics

col-narrow-left   

Job ID:

23128

Location:

Cambridge, MA 

Job function:

Research & Development
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Sr Supervisor, Pharmacometrics

Job Description:

Provides small molecule bioanalysis oversight, quality control, and data management to ensure successful conduct of Quantitative Pharmacology trials and support of document management for all programs in the development pipeline.
Essential Functions:
Bioassay Support:

- Serves as department liaison for all small molecule bioanalytical activities.

- Oversees development, validation, and trouble-shooting support for assays.

- Manages appropriation of reference standards.

- Responsible for all other bioassay activities related to department responsibilities.
QC Support:

- Manages the QC workload to perform data checking of Master Study Files to department reports (IB, Annual Reports, Clinical Study Reports, Dept. Summary Reports)

- Ensures compliance with Standard Operating Procedures (SOP)

- Maintains Study Number Master List

- Acts as department QA at CRO
Data Management:

- Maintains & requests IT Permission changes on pertinent files/folders as necessary

- Software Administrator (BPO)

- On-site archivist of files and historical products

*LI-RD2

Job Requirements:

QualificationsPossesses a strong understanding of the science being conducted with emphasis on bioanalysis, also knowledgeable on protocol specifications, data transfer, PK/PD analysis, and reporting. Familiar with QC procedures in drug development. General understanding of regulatory standards with at least 5 years of experience in the Pharmaceutical Industry.
- Exceptional planning & organizational skills.
- Exceptional attention to detail & timelines.
- Excellent communication & interpersonal skills.
- Ability to understand the design of experiments and the analysis used to review final reports.
- Able to assess and manage a diverse, time-sensitive workload. EducationBS/MS degree in a scientific discipline. Incumbent typically has 5+ years in drug development R&D within an industry setting. Has significant expertise in small molecule bioanalysis and is familiar with QC procedures. Excellent communication skills. About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

Zip Code:

02142
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