inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients’ therapies to market
Post: Manager, Medical Writing
Job Description
- Manage and oversee the preparation of clinical regulatory documents, which includes managing medical writing activities performed by staff writers and external writing consultants.
- Assist with budgeting, revenue, invoicing and forecasting as requested.
- Review and edit documents or sections of documents prepared by other writers (internal or contractors).
- Ensure adherence to client objectives and that quality standards are maintained.
- Support the company's medical writing leadership team in the planning, development and implementation of document development strategies.
- Build and maintain relationships with internal and external customers.
- Form, maintain, and lead productive cross-functional working teams, including addressing issues that arise.
- Develop templates and guidelines for clinical documentation and act as resource for implementation.
- Contribute to departmental metrics.
- Support medical writing leadership with development and presentation of quarterly business updates.
- Develop and maintain departmental Standard Operating Procedures (SOPs) for scientific communications services.
- Support business development activities by assisting with proposal and costing development as well as bid defense and customer meetings.
- Assist in tracking, maintaining, and reviewing project metrics.
Candidate Profile
- Bachelors Degree in Science or relevant discipline. MS, MPH, PharmD, PhD, or other advanced degree is strongly preferred.
- Min 8 years relevant experience in medical/technical writing within the pharmaceutical, biotechnology, or CRO industry and previous line management experience of min 2 years preferred.
- Knowledge of ICH guidance governing drug and document development as well as editorial and publications processes, systems and procedures.
- Track record of successful relationships in building and maintaining relationships with customers, both internal and external.
- Strong management and independent work skills; strong resource planning skills, strong written composition and editorial skills; program planning and implementation skills; and demonstrated copywriting skills.
Additional Information:
Qualification: Bachelor's Degree
Job ID: 16319
Location: Hyderabad
Functional Area: Medical Writing
Last Date: 15th November, 2017
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