PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.
Post: Senior Manager Medical Writing - Mumbai-122352
Job Description:
Oversees the Medical Writing staff and projects to deliver quality products in agreed timelines. Assists in developing the Medical Writing organizational structure, recruiting, training and motivating staff to ensure performance excellence. Assists with developing and managing the operating budgets and identifies new business opportunities & Medical Writing projects. Collaborates internally and with external clients. Resolves complex problems to meet client deliverables and needs. Leads operational excellence initiatives and process improvements within the department.
Qualifications
Minimum Required Education and Experience:
Bachelor’s degree in a science-related field required
10+ years of relevant experience managing and directing complex medical writing projects
5+ years of management responsibility
Relevant experience working in the pharmaceutical/CRO industry is preferred
Advanced degree (PharmD. PhD, Masters) is preferred
Additional qualifications in medical writing (AMWA, RAC, etc.) advantageous Or an equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
Required Knowledge, Skills and Abilities:
- Strong leadership skills with the ability to manage people including performance, training, mentoring, directing and motivating staff
- Excellent project management skills, including the ability to plan and manage projects, create and modify budgets, develop timelines, allocate resources, and forecast departmental workload
- Excellent knowledge of global/regional medical writing/regulatory requirements for clinical trials, marketing authorization and late phase procedures
- Knowledge of budgeting, forecasting, and departmental and project finances
- Experience across aspects of the product development lifecycle
- Excellent understanding of business principles, including contracts and proposals
- Effective presentation skills for use in client presentations
- Innovation and leadership in developing new ideas related to Medical Writing, including process improvements
- Excellent medical writing skills, including grammatical, editorial, and proofreading skills, and the ability to interpret and present complex data
- Ability to effectively communicate with potential clients, corporate leaders and across functional areas
- Attention to detail and quality
- Excellent interpersonal skills including problem solving, judgment, and decision-making skills
- Excellent understanding of computers and their applications
- Organizational and planning skill
- Strong negotiation skills
- Self-motivated and adaptable
- Ability to work independently on own initiative as well a part of a team
- Broad regulatory experience an advantage
- Excellent knowledge of relevant ICH and other global regulatory and document development guidelines
- In-depth knowledge in a specialty area; preclinical, therapeutic, regulatory, submissions, communication, etc.
Additional Information:
Experience: 10+ Years
Location: Maharashtra-Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writing
Job Code: 122352
End Date: 15th May, 2015
See All B.Pharm Alerts B.Sc Alerts Mumbai Alerts
See All Other Jobs in our Database
.png)
