job details for:
Clinical Research - Senior or Principal Medical Writer Jobs - London

Clinical Research - Senior or Principal Medical Writer Jobs - London (Job Ref: WR/JOBS/22371-8855)

Job Description :

Job Summary

Flame Pharma Clinical Research - Senior or Principal Medical Writer Job – London:

Flame Pharma are currently working with one of the World’s leading Clinical Research Organisations to recruit a Senior or Principal Medical Writer to be based in London.  This fantastic medical writing opportunity would suit an experienced medical writer/senior medical writer looking for that career advancement that only an organization with such a high profile standing within the clinical research and medical writing sectors can give.  If you require a new challenge with a world leader, contact Flame Pharma today.

Job Title

Senior/Principal Medical Writer

Background

For two decades, our client has played a key role in the pharmaceutical, biotechnology and medical device industries by partnering with clients to accelerate time to market, control development costs, reduce risk and maximise return on investment. As one of the World’s largest Clinical Research Organisations , they deliver a full range of services and solutions through its worldwide offices. They are now working with Flame Pharma to recruit a Senior Medical Writer or Principal Medical Writer.

Key Responsibilities

• Researches, creates, and edits all documents associated with clinical research
• Acting as primary client contact for medical writing projects.
• Working with other internal departments and clients to set and meet internal and external deliverable timelines
• Leadership, training and support of junior medical writing staff
• Writing clinical documents for submission to North American and European regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, CTD clinical overviews and summaries, expert reports, safety updates, integrated summaries of safety and efficacy
• Preparation of clinical documents that are not necessarily part of regulatory submissions, including but not limited to study manuals, monitoring guidelines, position papers and manuscripts
• Facilitates process improvement and technical mentoring/training
• Supports Medical Writing Services management during the sales process by providing client liaison and proposals input

Qualifications and Experience

• Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent
• Extensive medical writing experience in a clinical research organisation, or many years of equivalent experience in a pharmaceutical or biotechnology firm
• Experience in management of complex medical writing projects
Senior Medical Writer
• Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines
• Extensive clinical/scientific/medical writing skills
• Excellent written and oral communication and interpersonal skills
• Team leadership skills
• Sound clinical foundation (e.g. knowledge of immunology, oncology, cardiology, etc.) is essential
• Prefer advanced word processing skills, familiarity with Word for Windows
• Fluent in written and spoken English
Principal Medical Writer
• Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines
• Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company
• Team orientated
• Strong written and oral communications skills, as well as excellent interpersonal and negotiation skills
• Knowledge of resource management and productivity metric management
• Motivation to work consistently in a fast-paced, rapidly changing environment
• Strong word processing skills, including familiarity with MS Word for Windows
• Fluent in written and spoken English

Benefits

This represents a challenging career with a lot of responsibility and excellent opportunities for progression. An attractive remuneration package will be offered to successful candidates including a competitive salary.

Key Words

Medical Writer, Senior Medical Writer, Principal Medical Writer, Medical Writing, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

This position is to be based in London.

For further details about this role, please contact Flame Pharma.