Opening for Regulatory C.M.C Scientific Writer in Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.

Post: Regulatory C.M.C Scientific Writer-1418259

Job Description
PURPOSE
Supervise and manage an assigned team of project delivery associates (including senior individual contributor roles) who manage or support studies to ensure quality, time and budget deliverables are met. Work with staff to ensure that all project deliverables are completed ensuring quality deliverables on time and in accordance with Standard Operating Procedures (SOP), policies and practices. Ensure that employees are trained and individual development is aligned and in place to meet project and organizational needs. Oversee assigned project(s), lead and manage the assigned work streams. Line manage Team Leads; mentor junior people managers.

RESPONSIBILITIES
· Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning,
· Assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
· Participate in the selection and on boarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct on boarding training for new staff in conjunction with Human Resources and Global Talent training programs.
· Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, Standard Operating Procedures (SOP) review and mentored training experiences, as applicable.
· Participate in the allocation of resources to projects by assigning staff to studies that are appropriate to their experience and training.
· Manage the quality of assigned staff's work through regular review and evaluation of work product.
· Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
· Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by Management.
· Assist in ensuring consistent standardized processes are implemented and department deliverables meet expected quality, financial and productivity targets.
· Ensure timely movement of project work through the process steps, in accordance with governing Standard operating Procedures (SOP) and working instructions
· Develop specialist expertise in aligned specialist areas, as well as applying them across various functions
· Prepare presentation materials for department meetings
· Works constructively in a matrix framework to achieve project and internal stakeholder deliverables. Actively contribute to initiatives and work in close collaboration with Operations team
· Participate in Department quality and/ or process initiatives.
· Mentor Leads/ Associate Managers as assigned.
· Assist in meeting department financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
· In-depth knowledge and ability to apply GCP/ICH and applicable regulatory guidelines • Basic therapeutic and protocol knowledge
· Strong communication and interpersonal skills, including good command of English language
· Excellent organizational and problem solving skills
· Demonstrated ability to deliver results to the appropriate quality and timeline metrics
· Good leadership skills
· Good teamwork skills
· Strong mentoring skills
· Effective presentation skills
· Excellent customer service skills
· Ability to work under limited direction
· Strong software and computer skills, including MS Office applications
· Effective time management skills and ability to manage competing priorities
· Ability to establish and maintain effective working relationships with coworkers, managers and clients

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MINIMUM REQUIRED EDUCATION AND EXPERIENCE
· Bachelor's degree in life sciences or related field and 7 years relevant experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS
· Extensive use of keyboard requiring repetitive motion of fingers.
· Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
· Regular sitting for extended periods of time. May require to work in shifts.
· May require occasional travel.

Additional Information:
Experience: 7 years
Location: India
Education: Bachelor's degree in life sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Other
End Date: 14^th May, 2015