PAREXEL, a global CRO, assists clients in the worldwide pharmaceutical, biotechnology and medical device industries with the development and launch of their products in order to bring safe and effective treatments to the global marketplace for the patients who need them. Headquartered near Boston, Massachusetts, PAREXEL operates in 69 locations throughout 52 countries around the world, and has approximately 9,000 employees.

An Opportunity has arisen for:-

Manager or Associate Director, Medical Writing Services Asia

PAREXEL Medical Writing Services prepares high quality documents across the clinical phase of drug development. As well as clinical protocols and study reports, we also undertake more complex assignments such as clinical sections of CTD and NDA submissions, and pharmacovigilance documentation.

This position will be based in one of PAREXEL’s offices in Asia. Responsibilities include: line management of the medical writing team in Asia; oversight of Medical Writing standalone projects, and Medical Writing input to full service projects; process improvement; mentoring and training as required; and input to business development activities. The role could be an opportunity for an experienced medical writer to gain experience of the challenges and rewards of a management level position within a highly successful Medical Writing department.

This is a permanent position.

Candidate Profile:

• Education: Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
• Broad experience in management of complex regulatory medical writing projects
• Previous line management experience desirable, but not essential
• Skills: Excellent interpersonal, negotiating, verbal and written communication skills; Professional attitude; Client focused approach to work; Able to work both independently and as part of the team; Ability to manage and prioritize multiple and varied tasks with enthusiasm and attention to detail; Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company; Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines; Strong word processing skills.

Please send your CV to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it  or call Evelyn Koh on +886 2 27271100 ext. 1317, or Julia Cooper on +44 1895 614403, to arrange a confidential discussion about this role.

Experienced Medical/Regulatory Writers Needed

2 in Paris; 2 in Buckinghamshire, UK

Synchrogenix Europe, Ltd, is seeking experienced medical/regulatory writers for 2 positions in Paris and 2 positions in High Wycombe (near London), UK.

The UK positions will be based in our High Wycombe office. The Paris positions will be based on the site of one of our largest pharmaceutical clients. These are permanent, full-time positions.

Responsibilities

• Write and edit strategic regulatory documents to move pharmaceutical and biotech products through global regulatory processes.
• Actively participate in project management/client relations.

Qualifications

• Preferably an MD, PhD, PharmD, or other advanced life sciences degree.
• Experience writing some, but not necessarily all, of the following documents: CSRs, INDs, NDAs, PK studies, ISS, ISE, CSS, CSE, IBs, PSURs.
• Familiarity with ICH guidelines.
• For the Paris positions, fluency in French and English.

Who is Synchrogenix?

Synchrogenix Information Strategies Inc., www.synchrogenix.com, is a medical/regulatory/scientific communications company, founded on the principles of ethical business practices and high-quality work. Synchrogenix is headquartered in Wilmington, Delaware, US, with offices in Greater Philadelphia and Boston, as well as wholly owned subsidiaries in the UK and Manila, Philippines. Established in 1986, Synchrogenix develops strategic regulatory documents for Fortune 500 companies in the pharmaceutical, biotech, and other highly regulated industries, and guides them through global regulatory bodies.

Why choose Synchrogenix?

Synchrogenix is a learning-oriented organization that is strongly committed to the idea that every individual—regardless of experience level—has something to teach and something to learn. Because we have such a wide range of global clients and locations, we apply international best practices. We provide competitive compensation, work-life balance, and a friendly, flexible working environment.

Please submit CV to Stan Yau at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .
Include Paris EMWA or UK EMWA in subject line.
Tel 00 1 302 8924800.

HRA Pharma is a privately-owned European pharmaceutical company that develops and markets innovative products in the fields of reproductive health and endocrinology.

Headquartered in Paris (France), HRA Pharma has a strong international activity. Its subsidiaries are located in Germany, the United Kingdom, France, Italy, Spain and the United States.

MEDICAL WRITER

Position based in Paris.

Within the Research and Development department, you will be in charge of the written production of scientific/medical documents used in clinical/preclinical studies and medical-marketing activities.

Your main responsibilities will be :

• Write and edit clinical/preclinical study protocols, amendments and reports,
• Elaborate and edit investigator’s brochures and product monographs,
• Write and edit clinical/preclinical parts of dossiers for registration, pricing and reimbursement of drugs (including preparation of responses to regulatory authorities),
• Write and edit medical texts such as abstracts, posters and manuscripts for publication,
• Develop and edit medical communication tools, including slide presentations.

Your profile:

University degree (PhD/MD) in medicine, natural or health sciences, or pharmacy.
Prior medical writing experience within healthcare industry (>2 years).
Excellent written and verbal communication skills.
Computer literacy (Word, PowerPoint).

This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
http://www.hra-pharma.com
15 rue Béranger 75003 PARIS

Are you looking for an exciting new challenge and the right opportunity?

The UBC-Envision Group has clients across the world and offices in the UK and USA. With a range of unique scientific and cutting-edge technology solutions including Datavision™, we are market leaders in medical communications.

Due to significant expansion we have opportunities for medical writers and scientific team leads in our Horsham and Hammersmith, UK offices, which offer exciting challenges in a scientifically stimulating environment.

Ideally, you will have worked in medical communications and have a relevant higher degree (or equivalent). A proven track record of medical writing and editing, plus an exceptional eye for detail are essential.

As a medical writer/scientific team lead you will (depending on level of experience) demonstrate excellent writing and quality control, serve as key client/author liaison, champion key therapeutic areas, be responsible for managing your projects and successfully delivering outputs, instruct/mentor other medical writers, and have an appreciation of the nuances of publication planning, strategy and implementation. Yes, you will be conversant with the many and varied tasks of a scientific, medical communication professional.

We are a dynamic and rewarding company to work for, with excellent benefits and an informal, friendly and vibrant work environment. Please email your CV to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it , or alternatively, visit www.ubc-envisiongroup.com for the latest career opportunities

STRICTLY NO AGENCIES

ANTISENSE PHARMA GmbH, winner of the Bavarian Innovation Award and the German Founders Award, has been honored as one of the 100 most innovative middle size companies in 2009. We are a biopharmaceutical company led by an experienced management board and a top team of managers, with business and clinical background, as well as by internationally renowned scientists. We are focused on developing drugs in the field of oncology and novel substances for the treatment of currently incurable diseases. On the basis of our clinical success we aim to advance our lead molecules to the market. Our company is located in Regensburg, a city designated a UNESCO World heritage site, also referred to as the "northernmost city of Italy". High technology, cultural highlights and close proximity to Munich make Regensburg an attractive place to live.

ANTISENSE PHARMA GmbH
for the attention of
Ms. Kňazúrová
Josef-Engert-Str. 9
93053 Regensburg
Phone: +49-(0)-941-92013-0
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

Scope of Position:

• - Preparation of varied document types for preclinical and clinical studies as study protocols, reports, Investigator's Brochure and regulatory submission documents according to FDA and ICH guidelines
• - Preparation of regulatory submission documents in CTD format
• - Close cooperation with the Clinical and Preclinical Research, Regulatory Affairs and Marketing Departments
• - Writing, editing and designing of publications, abstracts and posters
• - Research, analysis and preparation of scientific literature

Required Knowledge and Skills:

• - Degree in life sciences or medicine
• - Perennial experience in medical writing acquired in Pharmaceutical companies, CROs or medical writing agencies
• - Advanced scientific writing skills and ability to analyze and summarize data
• - Systematic approach, good analytical skills and meticulous attention to detail
• - Excellent communication skills both written and verbal in English and German
• - Very good interpersonal skills
• - Strong knowledge of Microsoft Office and graphical software

We will offer an ambitious, scientific setting, excellent working conditions in a friendly atmosphere. We are looking forward to welcoming you as a future member of our team.

Please visit our website www.antisense-pharma.com

npsm ltd
is a successful medical communications company located in Switzerland. We implement clinical and marketing projects for international customers in the pharmaceutical industry.

nspm provides a complete medical writing service across a broad spectrum of therapeutic areas, with the experience and expertise of our highly qualified in-house medical writers. For our team, we are currently looking for a

SENIOR MEDICAL WRITER

YOUR PROFILE

• University degree and higher education (PhD/MD) in medicine, natural or health sciences, or pharmacy
• Fluent written and spoken English
• At least two years editorial or medical writing experience in the pharmaceutical industry
• Client oriented
• Effective communication skills
• Computer literacy (PowerPoint/Word)

YOUR MAIN RESPONSIBILITIES

• Writing and editing medical texts, including abstracts, publications and manuscripts
• Developing and editing medical communication tools, including slide presentations
• Organising scientific symposia and meetings

WE OFFER

• A stimulating job in a friendly and innovative environment
• An experienced and highly motivated international team
• Swiss salary with generous social benefits
• 6 weeks holiday

If you are interested in a challenging position and working in the heart of Switzerland, please send your CV by e-mail to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

For further information, please call Dr. Ian Leighton at +41 41 377 53 41.

Applicants who apply to nspm directly (rather than via an employment agency) will receive a cash bonus if they are employed by nspm.

www.nspm.com

nspm ltd, Luzernerstrase 36, CH-6045 Meggen, Switzerland

Opportunities for experienced medical writers
Medical communications
Basel, London or Manchester

Are you an experienced medical writer seeking an exciting new opportunity within medical communications?

The Nucleus Group includes the medical communications agencies MediTech Media, Health Interactions and Articulate Science, and the medical publisher International Medical Press. We are an independent, global group of companies specializing in medical communications, with approximately 350 employees in 12 offices around the globe.

Due to continued growth, we have a number of exciting opportunities for experienced medical writers at all levels to join our dynamic and employee-focused organization. We are particularly proud of our strong scientific knowledge, quality of service and innovative approach to today’s challenges in medical communications. You will be part of a team delivering high-quality medical communication services to blue-chip pharmaceutical clients and international scientific societies across a number of different therapy areas.

What is it like to work at the Nucleus Group?

We work in a friendly and informal environment where employees feel challenged and can develop their skills, and where their contribution is recognized. You will have the opportunity to apply your in-depth scientific knowledge and strong editorial skills to a range of exciting and varied programmes. As a company we offer excellent opportunities to progress your career within the UK or by transferring to other offices around the globe.

To be successful, you will have a strong life sciences background to BSc, MSc or PhD level and at least 2 years’ experience within a medical communications agency or the pharmaceutical industry.

To find out more about these opportunities, please go to www.nucleusholdings.com or send a copy of your current curriculum vitae and covering letter to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .

Clinical Safety Manager / Scientist - SERM Pharmacovigilance
Weybridge - Surrey or Stockley Park - West London, South East England

This is an exciting opportunity to join GSK as a full-time Safety Manager primarily responsible for the continued safety assessment, evaluation and risk management of GSK products or product groups in clinical development and/or the post-marketing setting within the Safety Evaluation and Risk Management (SERM) group.

The Safety Manager ensures that adverse event and other safety information is efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives

In this role, you would be responsible for leading risk management activities, providing significant and proactive clinical safety input on crossfunctional teams and ensures that appropriate safety objectives and risk minimisation strategies are included in clinical development programs

The ideal candidate will:

• Function independently in crossfunctional teams, exhibit a proactive approach, and who is able to lead the safety group within the project teams, with influencing skills and personal strength and impact.
• Understand the big picture as well as having an eye for detail.
• Demonstrate initiative in solving problems, with the ability to manage tasks and projects and be able to prioritise and deliver within timelines.
• Be able to communicate at all levels within a matrix organisation.

In addition, you will play a pivotal role in the writing and creation of regulatory documents, such as PSURs, responses to regulatory enquiries and global core labelling. Working as part of a team, you’ll be given full support and training as well as the excellent package you can expect from GSK.

Basic qualifications required:

• Biomedical degree (or equivalent), or higher.

Preferred qualifications:

• Clinical Safety and Pharmacovigilance experience or other relevant experience such as project management within pharmaceutical industry, medical writing, regulatory affairs or clinical development experience.
• Excellent oral and written communication skills.
• Sound computer skills.
• Awareness of international pharmacovigilance requirements for example ICH. Vol 9 Notice to Applicants, and CIOMS initiatives.

Closing date for applications: 31 January 2010.

Please indicate which location (Weybridge or Stockley Park, West London) you are applying for.

To Apply:

Please apply online via GSK’s online application system by following the link below and searching for Req. ID 57074.

www.gsk.com/careers/uk-saa-jobsearch.htm

GSK is an equal opportunities employer and is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. To enable GSK to meet its commitment as a two ticks employer please let us know if you have a disability.