Senior Medical Writer EMEA

Employer
i-Pharm Consulting
Location
England
Salary
Negotiable
Closing date
28 Sep 2020
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SENIOR MEDICAL WRITER - EMEA

6 Month Contract

  • FTE

Home base - anywhere across Europe.

Global CRO

Competitive pay rate

Job Description

Provides high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients.

Provides technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise.

Effectively manages medical writing projects to deliver quality products in agreed timelines.

Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Independently researches, writes, and edits clinical study reports, study protocols and standard response documents.

Produces complex clinical or scientific documents, such as, IBs, and sections of INDs, NDAs, CTDs, and dossiers.

Provides senior review of documents and training/mentoring for other writers.

Manages all aspects of planning, organizing, and executing projects without supervision including: developing project timelines, standards, budgets, forecasts, and contract modifications.

Liaises with other functional units as necessary (i.e., project management, clinical, QA, data management, biostatistics, regulatory).

Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions.

May manage several long-term projects concurrently.

Represents Medical Writing in Project Launch Meetings,

Review meetings, client audits, bid defences, and capabilities presentations

Establishes and develops client relationships; independently initiates and leads interactions with clients.

Assists with business development and development of budgets and proposals.

Education and Experience:

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, & experience. Experience working in the pharmaceutical/CRO industry preferred

Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Knowledge, Skills and Abilities:

Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills

Strong project management skills

Excellent interpersonal skills including problem solving

Strong negotiation skills

Excellent oral and written communication skills with strong presentation skills

Significant knowledge of global, regional, national and other document development guidelines

In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.

Great judgment and decision-making skills

Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Life Sciences recruitment is what we do.

We are an award-winning international life sciences recruitment company with offices in London, New York, Munich, Singapore and Sydney.  In a highly competitive market-place, we connect top talent with the very best opportunities.

 

Our clients include many of the most successful and innovative Pharmaceutical, Biotechnology, and Medical Devices companies, as well as a range of Contract Research & Manufacturing Organisations, Healthcare Agencies and Consultancies.

 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

Contact Us
  • 212 New King’s Road
  • London
  • SW6 4NZ
  • GB
  • +44 (0) 20 3189 2299
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