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Job Details

(Contract) Medical Writer - Global CRO - Remotely based - 12 months

Company: Meet
Location: Remotely Based
Reference: GCMW0401
Closing Date: 28 Feb 18
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

An urgent need for an experienced Contract Medical Writer to join a global CRO on a 12-month contract. This is the ideal role for a Medical Writer with expertise in regulatory documents to work remotely on a range of interesting therapy areas.

Requirements:

With Headquarters based in the USA this global CRO have completed more than 50 submissions for drug approval over the last 5 years’, establishing themselves as a top choice for sponsors in the industry. They work with a range of clients, supporting companies from top 10 pharmaceuticals to smaller Biotechnology companies globally. This varied client base offers the opportunity for the successful candidate to work in a very dynamic environment.

In this role you will be the primary writer for a variety of regulatory documents, primarily CSRs and CTD modules 2.5 and 2.7. However, as an independently owned company they offer a lot of flexibility and the opportunity to gain exposure to a variety of documents. This is a remotely based, full-time position.

 

Contract Medical Writer – Global CRO - Remotely based - 12 months

Get in touch with Georgina Collings at Meet to discuss this or similar roles further!

 

Key responsibilities:

  • Act as the primary author of clinical regulatory documents, including clinical study protocols, clinical study reports, investigator’s brochures, and regulatory submissions.
  • Proactively manage writing activities across assigned projects; ensuring adherence to the medical writing strategy and set timelines.
  • Contribute to developing key messages for complex clinical regulatory documents.
  • May participate in developing standard operating processes and related procedures.
  • May mentor, or supervise junior staff in the Medical Writing department.
  • Represent the company as a key client contact; answering queries resolving and escalating any issues.

 

Key skills:

  • Minimum of a BA/BS in Life Science, a MSc or PhD is preferred.
  • Minimum of 3+ years medical writing experience in Pharma, Biotech and/or CRO.
  • Demonstrated expertise in writing/developing clinical documents for regulatory submissions.
  • A good ability to interpret and organize scientific and clinical data.
  • Experience as a project lead, or medical writing manager is an advantage.
  • Good Knowledge of ICH and electronic submission guidelines globally.

 

This role is suitable for: Freelance Medical Writer, Medical Writing Contractors, Regulatory Writers, Technical Writers, Contract Medical Writers, Medical Writing Freelancers with previous experience in the pharmaceutical industry.

 

Contract Medical Writer – Global CRO - Remotely based - 12 months

Get in touch with Georgina Collings at Meet to discuss this or similar roles further!

 

Keywords:

Medical Writer, Regulatory Writer, Scientific Writer, Clinical, Regulatory, Clinical Study Reports, CSR, CTD, Clinical Summaries, Clinical Overview, Protocols, Briefing Documents, Regulatory Authorities, CRO, Pharmaceutical, Bio-pharmaceutical, Biotechnology, FDA, MHRA, Phase II-IV, Therapeutic Areas, Oncology, remote, home-based, life sciences

Apply for this job: (Contract) Medical Writer - Global CRO - Remotely based - 12 months

Contact Information:

Address:  meet
Irongate House, 30 Dukes Place, London
EC3A 7HX
England
Tel:  +44 203 178 7488
Website:  Visit Our Web Site

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