CV, Curriculum Vitae and Online Resumes Search

---

Online Resumes with "ICH "

Results Oriented Supply Chain Professional

Supply Chain Prifessional, who is analytical, resourceful and results oriented.

Ideal Companies: Procter & Gamble Inc., Pfizer Canada, Petro-Canada, Cabadian Superior, Magna Corp., Abbott Canada, Federal Express Canada , Siemens, Shell, BHP Biliton, GlaxoSmithKline Inc., Eli Lily

Tags for this Online Resume: Purchasing, Supply Chain, Logistics

QA Director

At this time I would like to be a consultant or a temperary position to pharmaceutical companies for their quality or R&D problums. I have experience in dealing with FDA related issues in durg discovery and production. I can help the starter company to build up their quality system and train their employees to comply with the cGMP requirements by FDA. I do not mind to travel. I can speak, read and write Chinese in addition ...

Ideal Companies: Any company which can use my experience

Tags for this Online Resume: Qhality Assurance, QA, cGMP, FDA, ICH, Q7A, Inspection, Audit, Deviation Report, Change Control, OOS Report, Annual Report, DMF, validation, Purified Water, FDA Inspection

Clinical Data Manager

Implemented knowledge of ICH GCP and CDISC Standards. Proven organizational skills with the ability to learn quickly; excellent time management, meet tight deadlines; manage multiple tasks and changing priorities while working in a high-pressured environment. Reputable for my attention to detail skills and strong ability to respond and solve problems in real time to fulfill customer expectations. Ability to work effectively...

Tags for this Online Resume: organized, data, bilingual, pharmaceutical, SQL Language, SAS, ClinTrial, ClinAccess, detail oriented

Process/Chemical Engineer

I’m looking for opportunities where I can mix the hands-on work with process troubleshooting/optimization in combination of managing of a product/project from the decision-making level regarding capital projects, project direction, etc. I have worked on all facets in the lifecycle of a process/product from the R&D side in its development and optimization coming into a fully validated manufacturing process and then supporti...

Tags for this Online Resume: Chemical, Pharmaceutical, Process, Engineer, Manufacturing, Plant, Optimization

Sr. Clinical research Associate/ Director of clinical research

Can undertake most of the tasks and works independently. Very much focussed on the timelines and quite goal tending. Willing to help others in their prioritized tasks. Excellent planning, design and implementation. Highly experienced in writing reports and data analyses.

Ideal Companies: Pharmaceutical industries, Biotech companies, Research institutes, hospitals and for profit mid to large companies.

Tags for this Online Resume: Director of clinical research, Manager of drug safety, Senior clinical research associate, Regional clinical research associate

Clinical Supply Operation, Edison, NJ - 8+ Years of experience in pharmaceutical R&D, Clinical supply operations. Knowledge and experience in GMP, GCP and FDA/ICH guidelines. Good experience of computer programming and use of MS Suite of Applications, Dat

Vice President of Operations

To find a challenging position as a manager for a growth-oriented organization, which offers diverse job responsibility and possibility for advancement.

Tags for this Online Resume: General Manager, Vice President of Operations, Environmental and Safety

Regulatory Affairs Specialist

I Seek a fulltime Regulatory Affairs professional position that will utilize the achievements, skills, strategic thinking and leadership abilities that enable me to aid the company in timely submission packets; Wereby we consistently exceed earnings potentials and achieve company goals in any of today's global economic markets.

Tags for this Online Resume: Regulatory Affairs Professional, FDA 510(k), PMA, IDE, ICH, CE Markings, EU MDD, CMDCAS

Senior Regulatory Writer (17 years experience)

I am seeking to end my present consulting status and return to an in-house position where continuity of projects is more realized. I have over 15 years experience writing regulatory medical documents that comprise CFR21 356h NDA/BLAs and eCTDs deliverables to the FDA/EU/Canadian regulatory authorities. I have written approximately 85 CSRs and can confidently say that ~40 of these were NCEs, early phase I/II and some pha...

Tags for this Online Resume: Regulatory Medical Writer Manager level

CTA

Seeking for a challenging career in a progressive organization offering the opportunity for contributing my skills services to the organization and personal growth and to work sincerely with maximum effort using best talents and with a challenge to achieve required goals and targets, abiding to the decisions of seniors and to earn a good reputation what ever required.

Tags for this Online Resume:  Develop, maintain and manage appropriate study documentation,  Developing, writing and presenting the clinical trial protocols,  Initiate, maintain and reconcile Trial Master File.,  Monitoring the trial throughout its duration which will involve visiting the Study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise.,  Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other Data collection tools by careful source document review Monitor data for missing of implausible data.,  Complete Serious Adverse Event (SAE) reporting, process production of Reports, narratives and follow up of SAEs and managing the clinical data intermilitently as per 21CFR USFDA guidelines,  Monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.,  Independently perform CRF review; query generation and resolution against established data review guidelines on client data management systems as assigned Perform other duties as assigned by management., , maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned

Lead Project Manager- Clinical Trials

Proven expertise in managing teams, streamline project paths encompassing an understanding of scientific data, analysis and interpretation of results, clinical developability and commercial viability of projects.

Ideal Companies: Vertex Pharmaceuticals, Amgen Inc., Takeda Pharmaceuticals

Clinical Pharmacovigilance/Drug Safety

A pro-active and passionate doctor looking to secure a Pharmacovigilance position in a company with focused and goal-driven people, utilizing case processing, narrative writing and literature searching skills. Also to acquire new skills and to positively influence those around, subsequently adding value and growth to the company.

Tags for this Online Resume: pharmacovigilance, drug- safety, MedDRA, physician, ICH, data-analysis