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Job Details

DRA CMC Technical Writer

Company: SEC Recruitment
Location: Madrid
Reference: 0000009
Closing Date: 06 Dec 16
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

A medium sized global biopharmaceutical company is currently seeking an experienced CMC Technical Writer to join their team. This position has arisen due to a departmental restructure which will enable a more specialist approach to CMC Regulatory documentation. Primary responsibilities will include writing the CMC sections of CTAs, IMPDs, INDs and responses to agencies. This will be focused primarily on developmental but with some exposure to marketed product responsibilities also.

Requirements:

DRA CMC Technical Writer – Madrid, Spain – Salary based on experience, very competitive

If you would like to apply for the position or wish to learn more about the role and company please call Daniel on 0044 (0) 207 255 6665 or email your CV with a brief covering note to daniel.truman@secpharma.com

A medium sized global biopharmaceutical company is currently seeking an experienced CMC Technical Writer to join their team. This position has arisen due to a departmental restructure which will enable a more specialist approach to CMC Regulatory documentation. Primary responsibilities will include writing the CMC sections of CTAs, IMPDs, INDs and responses to agencies. This will be focused primarily on developmental but with some exposure to marketed product responsibilities also.

You will be based at the global headquarters. We are looking for established CMC Regulatory Technical Writer either from a Regulatory or R&D background. Ideally you would have a strong knowledge of FDA and ICH guidelines and the whole pharmaceutical development process. Experience which includes working with biologics and small molecules would be of benefit within this position.

You will be providing technical CMC knowledge and supporting Regulatory submissions throughout the pharmaceutical development process. This will require experience working with Regulatory, Quality, R&D and Manufacturing teams writing CMC sections for Regulatory Applications and responses to agencies.

If you would like to apply for the position or wish to learn more about the role and company please call Daniel on 0044 (0) 207 255 6665 or email your CV with a brief covering note to Daniel.Truman@secpharma.com

I am able to speak to you and share information regarding many Reg Affairs opportunities currently available and future vacancies.

SEC are a Recruitment and Employment Confederation member and ISO9001:2000 accredited specialist recruitment organisation working within the Pharmaceutical, Biotech and CRO industries. If you are interested to learn more about further opportunities in the UK and mainland Europe, please contact Daniel on 0044 (0) 20 7 255 6665 for a confidential discussion.

SEC Recruitment Limited is acting as an Employment Agency and or an Employment Business


Apply for this job: DRA CMC Technical Writer

Contact Information:

Address:  Head Office
3rd Floor, 13-15 Moorgate London.
EC2R 6AD
England
Tel:  00 44 (0) 207 255 6600
Fax:  00 44 (0) 1483 888997
Website:  Visit Our Web Site

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