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Job Details

CMC TECHNICAL SECTION AUTHOR (R&D Background)

Company: SEC Recruitment
Location: Barcelona
Reference: BBBH106779
Closing Date: 13 Dec 16
Type: Permanent
Salary (£): 40,000 - 60,000
Benefits: BONUS BENEFITS RELOCATION ASSISTANCE

Job Summary:

CMC TECHNICAL SECTION AUTHOR (R&D Background) *** SPAIN *** (Permanent role)? Multiple locations available (Barcelona or Madrid)? Only profiles having experience at authoring CMC SectionsCurrently being working with a leading biopharmaceutical company experiencing strong growth and advancing a promising pipeline to the market in anti-tumour drugs, I am looking for an experienced SPANISH SPEAKING R&D professional with Technical Writing experience in CMC Sections to join their teams in Madrid ...

Requirements:


CMC TECHNICAL SECTION AUTHOR (R&D Background) *** SPAIN *** (Permanent role)
? Multiple locations available (Barcelona or Madrid)
? Only profiles having experience at authoring CMC Sections

Currently being working with a leading biopharmaceutical company experiencing strong growth and advancing a promising pipeline to the market in anti-tumour drugs, I am looking for an experienced SPANISH SPEAKING R&D professional with Technical Writing experience in CMC Sections to join their teams in Madrid or Barcelona.
My client is indeed looking forward to recruit talented R&D professional having a solid track records at authoring successfully CMC sections within biologics or small molecules industrial developments & who would be keen on growing with a leading & innovative organization on the long run under the R&D Director orientation.

YOUR MAIN MISSIONS:
Under the orientation of the R&D Director & in close collaboration with the executive management you will be responsible for the following activities so as to ensure go to market of the pipeline by:
• Drafting of the CMC sections of the regulatory documents for the initiation of clinical trials or for marketing authorisation applications, as well as substantial amendments, variations, and regular updates,
• Writing the CMC sections of CTAs, IMPDs, INDs & managing CMC responses to regulatory agencies,
• Liaising with partners and/or CROs for the CMC-related parts of the submission dossiers to different countries,
• Assessing the internal information against applicable regulation or guidelines, as well as elaborating gap analyses focussed to the proposal of new or additional studies to give support to the applications,
• Monitoring the internal documentation contingent to on-going development projects,
• Representing your department for the assessment of solutions for corporate knowledge management.
Language requirements:

? Spanish: proficient
? English: proficient

NB: SPANISH proficiency is a mandatory requirement as you will receive technical documentation in Spanish & write in English.

IF YOU WOULD LIKE TO HEAR MORE:
If you would like to keep developing by joining global leading biopharmaceutical company in Spain whether in Madrid or Barcelona, be in touch urgently at caroline.mievre@secpharma.com with an updated copy of your CV for a confidential discussion of your expectations & full job descriptions and companies overviews.

WHAT’S IN IT FOR YOU?
In addition to several opportunities for further learning & development within a growing global company, the successful candidates will enjoy industry leading remuneration & benefit package composed of an uncapped basic salary (depending on backgrounds & locations) + bonus + benefits & full relocation assistance.

Caroline MIEVRE
(Bio)Pharmaceutical R&D Recruitment Specialist
https://uk.linkedin.com/in/caroline-mievre-rnd-recruiter
Tel: +44 (0)20 7255 6665
Fax: +44 (0)20 7255 6656
Email: Caroline.Mievre@secpharma.com
Web: www.secrecruitment.com

Apply for this job: CMC TECHNICAL SECTION AUTHOR (R&D Background)

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Tel:  00 44 (0) 207 255 6600
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