United Kingdom Schedule
: Permanent - Full Time - Office based
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 Senior Medical Writer
to join our client-based team, one of the leading global biopharmaceutical companies, mainly working in the fields of neurology and immunology. They work closely with both scientists and academics across the globe, and have a strong focus on new products and a dedicated 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:
Submissions documents in scope include: 1-3 protocols and study reports (CSRs); summary documents (including Integrated Summary of Safety [ISS], Integrated Summary of Efficacy [ISE], Overview, Summary), risk management plans (as needed), and study summaries (for posting to study registries) and parts of Investigational Drug Brochures, agency meeting briefing packages, INDs, IND, and EU Annual Safety Updates, and responses to agency questions and other documents that may be assigned.
It is the responsibility of the Senior Medical Writer to:
Education and Experience:
- 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
- Prepare submission documents for a regulatory audience, within a team environment, according to Company SOPs and templates
- Manage review and approval process of submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner. Provide process, content, and submission/document planning expertise to Submission Team, Satellite Team, and Team. Advise team on resource utilization, efficiencies, timelines, and interdependencies
- Participate in the of processes and tools related to document authoring, management, and quality control in support of the departmental goal to develop best-in-class processes, tools, and standards to foster open communication, quality, efficiency, and cost-effectiveness of document generation to support the delivery of high-quality documents within realistic and ambitious timelines. Share expertise within Medical Writing and therefore across Therapeutic Areas
Specific Role Requirements and Skills:
- Bachelor's degree
- 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
Our Benefits in UK:
- 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
The Application Process
- Pension contribution
- Life assurance
- 25 days holiday
- Child care vouchers
- Eye test vouchers
- Seniority bonus
- Excellent work-life balance
- Car allowance for defined roles
- 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
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/jobs please contact firstname.lastname@example.org for more information. Who will you be working for? About CROMSOURCE
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. Key words:
Senior Medical Writer, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated
Skills: Medical Writer, CRO, ICH-GCP, Medical Writing, Pharmaceutical Location: United Kingdom Share:
LinkedIn Facebook Twitter Email