CMC Technical Writer

Lawrence Harvey

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Job ID :

15041


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

North America,--Colorado,Fort Collins,


Key Skills :

Manager, CMC, Technical Writer


Salary :

Negotiable


Date Posted :

20 Jun, 2019



Company Name :

Lawrence Harvey


Location1 :

Fort Collins




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

Manager, CMC Technical Writer - Fort Collins, CO

An experienced technical Dossier (CTD) Development writer within R&D CMC (Chemistry, Manufacturing and Controls) to support the development of new and existing projects. This Dossier (CTD) Development person is responsible for the generation, ownership and oversight of the Module 3 (and M2 QoS) throughout its lifecycle from Phase 1 inception through to post approval lifecycle management. This person will work with functional teams in the preparation and review of CMC technical documents (including, but not limited to, formulation development/analytical protocols and reports, research proposals, summaries, INDs, NDAs, Annual Reports).

Responsibilities:

* Manage the Dossier (CTD, IMPD, IND, NDA, ASMF and DMF) for Indivior R&D Fort Collins (FC) supporting global Module 3 development, including M2 QoS, covering Drug Substance and Drug Product development, for both internal and external (3rd party) developments
* Lead M3 activities within the new and existing substance and product pipeline, ensuring the documentation of all technical aspects of the development are of the highest quality and with any issues highlighted to stakeholders in a timely manner.
* Develop and maintain M3 documents from first phase IND/IMPD in accordance with global and regional regulatory best practise through to post approval lifecycle management

Qualifications:

* Bachelor's Degree in scientific discipline required.
* Demonstrated CMC technical writing skills with at least 10 years of pharmaceutical industry experience in pharmaceutical manufacturing or development and regulatory submissions is required.
* Proven track record of delivering high quality work to tight deadlines.

Manager, CMC Technical Writer - Fort Collins, CO


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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