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31 يناير 2014
Associate Director
Job Description
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Org Marketing Statement
All over the world Pfizer colleagues are working together to positively impact health for everyone everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why as one of the global leaders in the biopharmaceutical industry Pfizer ismitted to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Org Marketing Statement
Regulatory CMC Associate Director is responsible for the development and execution ofplex CMC regulatory strategies submissions andpliance activities for biopharmaceutical development programs andmercial products.
Supports leads the preparation of CMC information for submission to global regulatory agencies generates CMC strategies assesses risks and develops contingency plans.
Acts as the Global CMC representative within crossfunctional project teams involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.
Accountable for assigned CMC programs managing daytoday delivery of plans and strategic activities for specific projects including Life Cycle Teams andpliance ofmercial products.
Acts independently to resolveplex issues and manage regulatory risks and ambiguous situations within project teams. Investigates opportunities for regulatory innovation promote the use of novel approaches within project team to resolve issues and problems.
Creates contributes to the development of internal policies processes and procedures supporting the progression and maintenance of the Pfizer biopharmaceutical portfolio at large. Leads document management and information management teams within Global CMC groups outside Global CMC.
Represents Regulatory CMC on due diligence teams and representing Pfizer on CMC focused pharmaceutical industry initiatives.
Role Description
Serves as a GCMC strategist for projects within product portfolios providing regulatory assessments and developing regulatory strategies.
Acts as the Global CMC representative within crossfunctional project teams. Accountable for assigned projects and activities independentlypleting work within assigned work groupproject teams for multiple projects.
Interprets CMC regulatory requirements develop strategies including novel approaches assess risks and develops contingencies. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.
Responsible for the development of CMC documentation coordination and management of global submissions including the assessment and management ofmercial license status maintenance of productpliance and management of change control.
Ability to collaborate effectively across a network of other stakeholders partners and customers to deliver high quality CMC submissions and ensuring thepliance of the Pfizer biopharmaceutical portfolio. Manages the resolution of regulatory CMCinformation management issues with projectprogram stakeholders.
Able to develop andor lead projects or team initiatives to support shortterm operational goals and contribute to the development of global regulatory initiatives.
Qualifications
Scientific degree in a relevant subject PhD preferred science related BSc or MSc required
An experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development andor biopharmaceutical manufacturing andor specific regulatory domain with 5 7 years experience in a relevant area. Proven ability to interpret and apply global regional CMC regulatory policies and requirements for assigned projects.
Candidate is required to have a broad functional knowledge of pharmaceutical sciences the Biopharmaceutical industry with a clear understanding of drug developmentmercial manufacturing of biopharmaceuticals. Experience of regulatory agency interactions is required.
Candidate is required to have a recognized demonstration of
Leadership skills influencing and persuading skills
Excellent crosscultural awareness and understanding
Fluency in the English Language is essential
Strategic thinking and decision making
Excellentmunication interpersonal and relationship building skills
Collaborative team player
Excellent planning organizational and project management skills
Proactive and flexible
Problem solving skills to propose and assess regulatory solutions to CMC issues and prepare contingency plans will be helpful. Experience in medical device development and registration is useful.
Technical Skill Requirements
Technical and scientific understanding of biopharmaceutical drug development with technical writing skills. May serve as Subject Matter Expert in specific relevant disciplines or recognized as a regulatory CMC resource for specific pharmaceutical science projects andor specialized expert in specific regulatory domains.
Competent working knowledge ofputer based systems such as Microsoft Office controlled documentation systems e.g. Documentum. Ability to learn and navigate trackingchange control systemspliant and consistent use of systems including GMP validated systems and willingness to train and support others in system use.
Physical Skill Requirements
General office based activities requiring the operation of telephone andputer systems. Occasional business travel including International travel maybe be required.
Equal Employment Opportunity
Pfizer ismitted to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. Pfizer alsoplies with all applicable national state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the applications for temporary visa classification andor sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas the resulting work authorization may be specific to Pfizer and the specific job andor work site. Pfizer may at its business discretion decide to or refrain from obtaining maintaining andor extending the temporary visa status andor sponsoring a colleague for permanent residency and or employment eligibility considering factors such as availability of qualified U.S. workers and the colleague's longterm prospects for securing lawful permanent residence among other reasons. Employment applicants requiring immigration sponsorship must disclose when initial application for employment is made whether or not they are legally authorized to work for Pfizer in the U.S. and if so whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise i more...NT
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