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Section:  Healthcare & Nursing   Vacancy 1338

Post:Manager, Regulatory Review - 22395 Salary contractual
Requirements and conditions
Age: Has no value
Gender Has no value
Education: no
Work schedule: Has no value
Work place: London
The announcement text:
New York Digitas USA

Counting as clients many of the world’s leading pharmaceutical, bioscience, and medical device companies, Digitas Health is a next-generation marketing agency that helps build healthcare brands that patients, caregivers, and healthcare professionals feel confident turning to and recommending when they are sick, in need, or helping others.

With offices in Philadelphia, New York, Boston and London, Digitas Health is frequently recognized as one of the best places to work by the Business Journals and as having the best work perks by CNN.com. The company is a recent Webby Award winner and the MM&M 2009 Agency of the Year.

Digitas Health is a unit of Digitas, leading global digital marketing and media agency. For more information, please visit www.digitashealth.com or follow us on Twitter @Digitas_Health.

JOB SUMMARY:

The Manager, Regulatory Review is responsible for the duties of a Regulatory Review Manager (RRM) and for managing a team of RRMs to ensure marketing materials for a client (or group of clients) follow the protocol established by our pharmaceutical company clients for regulatory review. The Manager plays a key role in establishing procedures for internal teams and advising on specific projects to aid smooth and fast review by clients.

DUTIES & RESPONSIBILITIES:

• Manage multiple direct reports at the Associate and Senior Associate level including responsibility for interviewing, hiring, onboarding, training, and career development
• Provide estimates for SOW development
• Determine and document Regulatory Review procedures for new clients
• Work with the VP/Director, Regulatory Review in the development of departmental SOPs
• Oversee work of reporting employees on daily basis, providing advice on projects in advance and helping to address problems as they arise
• Coordinate work among reporting staff to manage workflow and ensure appropriate coverage for all client needs including vacation coverage
• Review projects before they are sent to the external client
• Work with new internal client team(s) to establish appropriate procedures to meet the external client’s regulatory review procedures and meet Digitas Health quality standards
• Advise internal client team(s) on submission strategy and requirements to minimize review period and ensure external client(s) satisfaction

SKILLS & EXPERIENCE:

Minimum of a bachelor`s degree and 4 years of experience in the preparation of complex deliverables under tight deadline constraints is required. Management experience is required. Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite are required. Experience communicating with clients directly is required. Demonstrated knowledge of FDA pharmaceutical regulations through appropriate training or previous experience is preferred. Clear communication and attention to detail are essential. Clear, concise technical writing ability is required. Experience in Pharmaceutical Industry or Healthcare is preferred.

Note: This job specification should not be construed to imply that these requirements are the exclusive standards of the position. Performs other duties (or functions) as assigned.















Location: New York, NY


Compensation: Open

Principals only. Recruiters, please don`t contact this job poster.

Please, no phone calls about this job!

Please do not contact job poster about other services, products or commercial interests.




Contact information
Employer: ÈÍÔÎÊÎÍ. Ðåêðóòèíãîâàÿ ñëóæáà. Êèåâ.
Email:
Phone: 529 62 45 (âí. 22), ôàêñ: 529 24 83
Publication date: 2009-10-18 09:20:32

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