Company: Kyowa Kirin International plc
Location: Galashiels, Edinburgh
Closing Date: 28 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Pension, Private Medical Insurance, Income Protection, Life Assurance
Management responsibility over medical writing projects and preparation of high-quality documents in compliance with regulations.
Manager, Medical Writing
• Senior Medical Writing position with growing pharmaceutical company
• Based in the Scottish Borders, only 1 hour from Edinburgh
• Management responsibility over medical writing projects
Kyowa Kirin International plc (KKI) is within an exceptional time; with an enviable development pipeline, we are also entering an exciting pre-launch phase with an array of development and in-licensed global products which will join an expanding, successful product portfolio, with a focus on cancer supportive care, oncology and bone therapeutic areas.
Our parent company Kyowa Hakko Kirin, based in Japan substantially reinvests into R&D to create products at both early and late stage development. With a focus on core business areas of oncology, nephrology, and immunology/allergy, together we leverage antibody-related leading-edge technologies, including our POTELLIGENT® Technology to discover and develop innovative new drugs aiming to become a global specialty pharmaceutical company which contributes to the health and well-being of people around the world.
The Manager of Medical Writing will possess broad experience in regulatory/scientific/medical communications, writing, and editing. Management responsibility over medical writing projects and preparation of high-quality documents in compliance with regulations.
Participate as a member of clinical and medical writing teams and work in collaboration with multidisciplinary project teams.
• Lead document creation process in support of all clinical and regulatory document types (including components for IND/NDA/BLA) according to FDA, ICH, and other health and regulatory authority requirements and local regulations
o Drives document through the creation/review/approval process
o Provides guidance to Clinical Research, Biostatistics, and other functions on effective use of KKD guidelines
• Prepare, edit and review clinical documents with subject matter experts from function including but not limited to Medical Science, Clinical Pharmacology, Clinical Operations, Biostatistics, Regulatory Affairs, and Drug Safety
• Ownership of document templates including evaluation of compliance, adherence to guidelines, annual reviews, and definition within GRAPES
• Contribute to all document creation/review/approval SOPs subject to bi-annual review, assisting in management of medical writing projects outsourced to CROs and contract writers to assure quality and adherence to strategy, regulations, and SOPs
• Provide MW support to publication planning and external presentations for assigned study teams
• BS/MS degree in Life Sciences or Health Related Science degree
• Minimum of 8 years in Regulatory medical writing for a pharmaceutical, biotechnology, or contract research company
• Broad experience in regulatory/scientific/medical communications, writing, and editing
• Experience authoring CTD Module 2 for NDAs and MAAs
• Understanding of clinical regulatory documentation requirements.
• Experience as lead-writer for key documents in major US and international regulatory submissions
• Experience managing medical/scientific communication vendors and contract medical writers
• Pension scheme
• Private medical insurance
• Life Assurance, Income Protection
• Other voluntary benefits include: Childcare Vouchers, Bike to Work
You will be rewarded with an excellent package, commensurate to the level of this role, and will be based in Galashiels within the beautiful Scottish Borders; Edinburgh being only a 50 minute commute away, providing you with the opportunity to truly appreciate the great outdoors and city living.
Kyowa Kirin International is an equal opportunities employer.
Galabank Business Park, Galashiels , Selkirkshire
|Tel:||+44 1896 664000|
|Website:||Visit Our Web Site|
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