Clinical Research Manager

Clinical Research Manager

Candidate will plan, lead and coordinate tasks supporting the timely delivery of high quality documents for NDAs/MAAs or complex sNDAs/Type II Variations to Health Authorities (HA) and for related follow-up activities (e.g. 120-day update reports (120DUR), answers to HA questions, briefing book, oral explanation and advisory committee), as well as to manage the logistical aspects of building the clinical sections of a submission dossier; in addition, to coach or mentor less experienced clinical submission managers.  The candidate will be responsible to function as submission expert for the Oncology Business Unit (OBU). Primary contact for operational submission related activities for assigned brand(s).  Responsible for all activities related to the development and internal approval of high quality submission documents (e.g. SCS, SCE, CO, 120DUR, etc.) in collaboration with the CPL/BSL who retain the accountability. These activities are performed according to internal and external guidelines, strategic timing and brand’s development plan and strategy.  Write/edit documents for submissions (e.g. answers to HA questions, risk management plan).  Set up and lead the clinical submission team in collaboration with the CPL/CIL. Organize and chair the dossier preparation meeting and the regular clinical submission team meetings. Communicate status report within and outside OBU.  Lead activities for identifying the clinical components of the submission (e.g. list of studies, list of documents) in collaboration with the DRA manager. Organize preparation, review and approval of clinical documents.  Develop, negotiate and track timelines, accountabilities and responsibilities for clinical and safety components of submission by partnering with CPL, DRA Manager, PJM and other line functions within CD&MA and OBU (DOC, B&SR, IMS). Ensure delivery of documents according to client processes and defined timelines.  Identify issues and resource gaps for the preparation and delivery of the different documents; ensure resolution of issues including anticipation, negotiate and implement solutions in collaboration with CPL/CIL.  Contribute to inter- and cross-unit fertilization of other clinical documents (e.g. protocols) by providing operational consistency.  Coach or mentor less experienced clinical submission managers.  Responsible for OBU clinical document templates (e.g. OBU clinical protocol); OBU representative for development-wide clinical document templates (e.g. clinical study report, CTC documents).  Contribute to continuous improvement of submission processing and knowledge transfer within OBU. Contribute to cross-functional initiatives; serve as author or reviewer for clinical SOPs.  Position requires an advanced degree or equivalent education/degree in life sciences/healthcare and must be fluent in English, both oral and written.  Candidate shall have seven years experience in clinical research with proven proficiency in global development; successful experience in multiple NDAs/MAAs and/or sNDAs/Type II Variations; demonstrated medical writing skills; solid leadership talent and advanced negotiation skills; proven ability to lead cross-functional teams. Also required is demonstrated teamwork, communication and organizational skills; works effectively and is able to establish relationships with other line functions.
Candidate must have excellent knowledge in worldwide regulatory requirements for drug registration and global, cross-cultural perspective and customer orientation.

Please refer to job code TP5977 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Livingston, NJ
County:	Essex County
ZIP Code:	07039
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856