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As a Medical Affairs Manager, your role traverses a wide spectrum of areas from selecting which pre-clinical candidates to pursue into clinical trials and developing optimized clinical trial strategies, through to dealing with KOLs, running investigator meetings, and preparing your company and relevant documentation for the regulatory authorities.

The PHASE II International team has built an enviable reputation for assisting clients achieve in all of these areas.

From optimizing a product's target profile to developing a new product's clinical trial strategy through to medical education, training, publication planning and medical writing, PHASE II can help.

Browse this section to see how PHASE II can assist you across your workload including:

	Clinical trial strategy optimization: planning, executing and managing phase I-IV clinical trials, including target product profile optimization, formulating development plans, evaluation of data from proof of concept and pivotal trials.
	Regulatory writing support: clinical assessments, risk benefit analysis, compiling clinical dossiers and databases, assessing dossiers for NDA/ EMEA submission, writing expert reports for NDA/ EMEA registration, writing overviews of efficacy and safety, compiling regulatory responses for NDA/ EMEA
	Participating in end of phase II meetings with regulatory authorities
	Development of therapeutic area training materials and workshop organization
	Medico-marketing strategies: value demonstration and health economics, quality of life, differentiation from competitors, publication and presentation planning and execution, review and editorial comment on manuscripts, posters, approval of copy for medico-marketing purposes.

Pre-clinical candidate selection Target product profile (TPP) optimization Clinical trial strategy Regulatory documentation Investigator meetings

Key opinion leaders Pre-marketing project plan Strategic publication planning Congress Pharmacoeconomic

Medical education Public relations Patient advocacy communication Market access Online communications Training

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Takeda online training Abbott Leuprorelin HE