Location: Germany - office based
Schedule: Full-Time, Permanent
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….
TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Medical Writer to join
our client-based team at one of the leading global biopharmaceutical companies.
Our client is a world leader, mainly working in the fields of neurology and immunology. Working with both scientists and academics across the globe, they have a focus on new products and a strong science based approach.
CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Main Job Tasks and Responsibilities:
- Write and prepare submissions documents within a team environment
- Ensure critical review and interpretation of efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation
- Manage the review and approval process of submissions documents; notify team of targeted review responsibilities. Generate consensus among reviewers, resolve conflicting comments, and facilitate discussions in an efficient manner
- Review and comment on documents in program (eg, protocols and statistical analysis plans) associated with project assignments
- Act as Program Medical Writer (as assigned). Provide process, content, and planning expertise to Team, Satellite Team, and Submission Team regarding document preparation, submission strategy and consistent scientific messaging. Advise team on Medical Writing resource utilization, efficiencies, timelines, and interdependencies. Oversee preparation of submission documents for a program; review and provide feedback on submission documents to maintain consistent content, messaging, and style
- Coordinate with other Program Medical Writers and other Medical Writers as needed to maintain consistency across documents within a project and across indications
- Participate in the of processes and tools related to authoring and reviewing of documents. Continually share best practices in an effort to create higher quality documents more efficiently
- Maintain and demonstrate comprehensive knowledge of drug process and applicable regulatory guidelines
- Maintain and demonstrate knowledge of company- and project-specific guidelines for the generation of submissions documents, including SOPs, templates, and document writing conventions and styles
- Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the writing of a document is outsourced. Such other responsibilities and projects as the company may assign
Education and Experience:
- Medical / Scientific university degree
- Experience in critical review and interpretation of efficacy and safety data
- Pharmaceutical background
- A professional certification (eg, AMWA, EMWA, RAPS, BELS) is a plus, but not essential
- Five or more years' experience performing quality checks to medical writing functions
- Fluent in English and German
- Demonstrated ability to work without close supervision
- Ability to work within an international team setting
- Ability to work under pressure
- Demonstrated ability to multi-task and to respond rapidly to changing priorities and aggressive timelines
- Must be detail-oriented, thorough, and methodical
- Exceptional written and verbal communication skills
- Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
- Exceptional problem-solving capabilities and organizational skills
- Exceptional proofreading skills
- Ability to focus on the details in a document without losing sight of the document messaging
- Intermediate knowledge of medical, pharmaceutical, and clinical research concepts, including a comprehensive understanding of the clinical trial procedures and drug development process
- A high degree of familiarity with statistical and data output
- Intermediate understanding of applicable regulations and guidelines (eg, Code of Federal Regulations, European Directive, and ICH) including CTD structure and content, CSR and summary document content
- Strong computer skills; proficiency in MS Office Suite, and EDMS
- Can manage uncertainty and shifting priorities and timelines
- Able to collaborate productively with colleagues and supervisors
- Able to adapt to working in a multicultural environment; able to adapt to change
- Able to think independently and apply principles across various situations and appropriately apply judgment to making changes
- Able to adopt an entrepreneurial and innovative style when necessary
The Benefits of Working for TalentSource in Germany
- 30 Euro net Internet cost reimbursement per month
- Additional Accident Insurance, fully covered by the company
- 25 vacation days (but up to 30 days, depending on negotiation)
- Possibility of salary conversion for additional pension insurance
- Dedicated Line Manager
- Monthly meetings with line manager
- Full performance and development process with end of year reviews
- Team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002608
https://www.talentsourcelifesciences.com/jobs please contact firstname.lastname@example.org for more information.
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
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