|
|
| 21 May 2010 Published weekly by Biotech Ink, LLC | Vol 3 No 15 |
|
|
|
|
|
|
 |
|
|
|
Open Jobs and Gigs for Medical Writers |
 The jobs listed in the Biotech Ink Insider weekly newsletter come to Susan Caldwell mostly by word-of-mouth and contact with hiring managers and recruiters.
Because of the tough job market, the Insider now lists open jobs worldwide that are closely related to medical writing, or that have a strong writing role, regardless of their titles. Examples include biostatistician, director of clinical research, and other clinical research titles.
If you receive calls about staff or contract medical writing or related positions that you aren't interested in, please forward the job information to Susan Caldwell at caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider. |
|
Associate Director, Regulatory Affairs, Oncology London, Middlesex, Berkshire, Surrey, Hertfordshire, Essex, Buckinghamshire |
Associate Director Regulatory Affairs / Oncology / London, Location: London, Middlesex, Berkshire, Surrey, Hertfordshire, Essex, Buckinghamshire Requirements: As a Global Regulatory Leader, you'll plan, manage and execute regulatory activities relating to one or more oncology projects. This will involve providing regional regulatory oncology strategic guidance on both development projects and marketed products. Background:My client is a well-established pharmaceutical company, with a focus on oncology, cardiovascular and metabolic diseases, CNS, and respiratory diseases. They are well respected in the industry, and staff retention is extremely high within this organization. Strong licensed and developing pipelines - oncology pipeline strengthened through acquisition. Primary Duties:
Manage/develop/hire EU therapeutic area product development regulatory affairs staff
Act as regulatory project lead for global project team on selected oncology projects
Ability to function as global leader is one of the key distinguishing necessities for this position
Serve as regional oncology regulatory representative for specific development projects or marketed products
Oversee interactions on therapeutic area projects with regional regulatory authorities
*Manage regional regulatory oncology product development resources
As assigned, is responsible for due diligence and feasibility assessments of candidates in area of therapeutic responsibility
Required Qualifications and Experience:
BS degree or equivalent in science; advanced degree preferred
Extensive pharmaceutical drug development experience and direct oncology regulatory affairs experience
Previous management experience essential
Contact:
If you wish to apply for this role, please contact Mark O'Halloran on +44(0)207 758 7311. Or, send your CV with a covering note to m.ohalloran@real-pharma.com. |
|
Medical Communications Scientist, Contract Wilmington, DE | |
The Contract Medical Communications Scientist provides medical communication expertise in the production of regulatory documentation (including regulatory dossiers, investigator brochures, protocols, FDA briefing documents) across product life cycle to ensure timely registration and sustain competitive products in the US.
Contract to extend through April 2011.
Degree or college major: Science background (eg, MS or PhD) Required work experience: 3-5 years Major Responsibilities:
Prepares regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards Critically assesses, interprets, and accurately summarizes medical data Promotes and exploits global working in the preparation of clinical contributions to regulatory dossiers Provides innovative advice and guidance on planning and resource forecasting for dossier and document production to enable competitive deadlines Interprets and monitors current and emerging communication issues and guidelines Manages contract resources through the effective use of project management skills to ensure the delivery of quality documents Qualifications:
Minimum Requirements:
-Baccalaureate degree in biomedical discipline -Knowledge of the drug development process and human pathophysiology and diseases -Excellent written and oral communication skills, manifested as the ability to express medical information accurately, clearly, and succinctly -Demonstrated ability to manage several projects simultaneously, including dealing with risk and issue management -Knowledge of regulatory requirements and guidelines and standards -Influencing, interpersonal skills -Able to travel nationally and internationally
Preferred Background:
-Advanced biomedical degree -Budget and resource management skills -Knowledge of competitors and competitor products -Editor in Life Sciences (ELS)
|
|
|
|
|
|
|
|
|
