Senior Medical Writer for Prague, Czech Republic

http://www.elc-group.com

ELC GROUP is a leading global services organization that helps clients expedite time-to-market through our services. These include a broad range of development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services. ELC GROUP delivers its customized solutions through its four core business segments: Regulatory Affairs Services Medical Devices EU REACH (Registration, Evaluation and Authorization of Chemicals) Regulation Services Corporate Languages Solutions (Translations, Design, DTP, Localization) The secret to our success is our ability to satisfy and retain clients. For you there will be more than 24 hours in a day and 7 days in a week - that's just how we do things. We understand that clients require fast turnarounds because of competitive pressure to get products onto the market. The benefits we bring to our client partners are numerous: Exceptional industry knowledge and experience at competitive pricing Superior leadership team abreast of all current industry trends, and continuously directing company initiatives toward solutions to market challenges A large, deeply talented project management team to ensure expedited project results without sacrificing quality Constant focus on communication enabling stronger client project participation and control Strength of diversity - our team is made up of over 15 different nationalities Peace of mind from knowing you have found the right partner

Job Description : 

• Preparation of Clinical overviews (CTD Module 2.5) and Clinical summaries (CTD Module 2.7)
• Preparation of Non-clinical overviews (CTD Module 2.4) and Non-clinical summaries (CTD Module 2.6)
• Preparation of Scientific justifications, Biowaiver justifications, Medical rationales for the medicinal product.
• Preparation of Addendum to Clinical Overviews
• Preparation of Environmental Risk Assessment reports 
• Preparation of Risk Management Plan (RMP)
• Preparation of Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
• Revision of the Medical Writing Documents (CTD Modules and RMP) as per agency assessment (e.g. Day-70, Day-100)
• Peer-reviewing the medical writing documents 
• Perform quality assurance of the medical writing documents
• Review of clinical study documents like Protocol, Case Record Form (CRF), Informed Consent Forms (ICF), Clinical Study Report (CSR)
• Monitoring of Clinical Trial and Bioequivalence Study
• Preparation of regulatory strategy / Due diligence reports
• Preparation of gap analysis for the contracted services
• Provide support in the content writing of product information such as SmPC and PIL 
• Provide training to junior staffs or medical writer
• Communication with the project managers and clients for the contracted medical writing services.
• Ensure the projects are delivered on the scheduled timeline.

Candidate must have minimum 8-10 years of work experience in medical writing with a focus on the writing of regulatory submission documents. 

Candidate must be comfortable travelling to countries or places within or outside India for official meetings or projects as and when required.

Candidate must have flexibility to work in different time zones to meet business needs if required.

Must have good command over English language.

Proficiency in MS office(Word, Excel, Powerpoint)

An organized, motivated, influential client oriented team player who works just as well independently

Email: vaishali.modak@elc-group.com