CMC Scientific Writer – Immuno-Oncology Biotech – SWITZERLAND
- Employer
- Planet Pharma Staffing Limited
- Location
- Switzerland Homebased
- Salary
- Competitive
- Start date
- 9 May 2022
- Closing date
- 8 Jun 2022
View more
- Discipline
- Quality, Regulatory Affairs, CMC, Regulatory Writing
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
We have an exciting opportunity available as a CMC Scientific Writer at an innovative European Immuno-Oncology Biotech. This is a fantastic opportunity for an experienced writer to join a very well funded, interesting company with exceedingly strong potential for development.
Reporting to the Global Head of CMC whilst working closely with one or more CMC Project Managers and Project Team members across functions like Medicinal Chemistry, Regulatory Affairs, Medical Writers and Quality Assurance.
Responsibilities
- Planning and authoring CMC regulatory documents such as IMPD, IND sections, Briefing Packages, ICH modules 2 and 3 for MAA / NDA/ BLA and responses to agency questions based on development reports, validation reports and other technical documents.
- Presenting CMC data as well as organizing and managing reviews for these documents. Management of corresponding supportive CMC documentation.
- Interaction with varied departments to establish priorities and deadlines for submission documentation
- Ensure that CMC documentation is collected from CDMOs and is available to support the writing of CMC sections, elaboration of PSF and for inspection
- Work closely with Global Head of CMC and CMC Project Managers including during the budget process
Requirements
- Scientific or technical training or advanced degree
- Experience in CMC writing within the biopharmaceutical industry – Minimum 3 years, ideal 5+ years
Following your application Simon Trebilcock, a specialist Scientific Recruiter with over 8 years’ experience recruiting in the scientific field will discuss the opportunity with you in detail. Eager to both give insight into the future of the opportunity and company but also learn more about your vision for your career growth. If desired Simon would look to remain in contact to alert you to opportunities which align with your interest and career plans.
This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click ‘apply’ or contact Simon Trebilcock for any further information
Email - strebilcock@planet-pharma.co.uk
Telephone - +44 (0) 203 868 1001 .
About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
Company
Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.
Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.
We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.
Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.
- Website
- http://www.planet-pharma.co.uk/
- Telephone
- +44 203 868 1000
- Location
-
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom
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