Senior Medical Writer, United Kingdom - P
CROMSOURCE
United Kingdom
6d ago

Description : Senior Medical Writer

Senior Medical Writer

Location : South East England

Schedule : Full time - Permanent or Freelance

TalentSource Life Sciences is currently searching for an experienced Senior Medical Writer to join one of our partner companies -

a leading international biopharma - in the South East of England.

This role is open to both permanent and freelance applicants. The successful candidate will be working on studies dedicated to one client.

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.

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 continuous support from your TalentSource Line Manager.

The Senior Medical Writer will be responsible for Clinical submission documents including Phase I - III protocols and clinical study reports (CSRs), summary documents, risk management plans, clinical study summaries, and the clinical parts of Investigational Drug Brochures, agency meeting briefing packages, INDs, the EU Annual Safety Updates, and responses to agency questions.

Responsibilities :

  • Write and prepare clinical submissions documents within a team environment, including but not limited to protocols, protocol amendments and clinical study reports.
  • Ensure critical review and interpretation of clinical efficacy and safety data.
  • Oversee the review and approval process of clinical submission documents. Generate consensus among reviews, resolve conflicting comments and facilitate discussions in an efficient manner.
  • Review and comment on documents in the clinical program (e.g. protocols and statistical analysis plans) associated with project assignments.
  • Act as a Clinical Program Medical Writer as assigned. Provide process, content and planning expertise to cross-functional teams regarding document preparation, submission strategy and consistent scientific messaging.
  • Advise team on Medical Writing resource utilization, efficiencies, timelines and interdependencies.
  • Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging and style.
  • Coordinate with other Medical Writers as needed to maintain consistency across documents within a project and across indications.
  • Participate in the development of processes and tools related to authoring and reviewing of clinical documents. Continually share best practices in an effort to create higher quality documents more efficiently.
  • Maintain and demonstrate expert knowledge of drug development process and applicable regulatory guidelines.
  • Maintain and demonstrate expert knowledge of company and project-specific guidelines for the generation of clinical submission 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 outsources.
  • Such other responsibilities and projects as the company may assign.

    Education

  • Bachelor's Degree in Life Sciences, Biological or health related field. Master's or PhD is preferred.
  • Minimum Work Experience

  • Extensive experience in regulatory Medical Writing within the pharmaceutical industry is required.
  • Knowledge of the methods, techniques and procedures of Medical Writing tasks.
  • Prior Protocol, Protocol Amendment and Clinical Study Report writing experience
  • Experience, Skills, Knowledge

  • Knowledge of requirements and systems related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).
  • Detailed and experience-based understanding of applicable regulations and guidelines.
  • Experienced-based understanding of applicable regulations, Common Technical Document structure and content, including CSR and summary document content for regulatory submissions.
  • Knowledge of medical, pharmaceutical and clinical research concepts.
  • Excellent problem solving capabilities and organizational skills.
  • Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.
  • Ability to work within an international team.
  • Must be detail-orientated, thorough and methodical.
  • Excellent written and verbal communication skills.
  • Ability to exercise independent judgement in developing methods, techniques and evaluation criteria for obtaining results.
  • A high degree of familiarity with statistical and data output.
  • Can manage uncertainty, shifting priorities and timelines.
  • Able to think independently and apply principles across various situations and appropriately apply judgement to making changes.
  • Strong computer skills; proficiency in MS Word.
  • Mastery of the English language, with comprehensive understanding of English grammar and punctuation.
  • Why TalentSource Life Sciences / CROMSOURCE?

    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 independent, international Contract Research Organization (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe.

    Our international headquarters location is in Verona Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

    Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents.

    Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-

    qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-

    life balance and we offer flexible solutions for a high number of positions.

    The success of these core values are evidenced by our below industry average turnover rates.

    By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and regarding career.

    Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

    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.

    How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

    Keywords : Medical Writer, MW, Scientific Writer, Writer, Medical Writing, Technical Writer, Permanent, Contract, Freelance, Outsourced, Biopharma, Pharma, Pharmaceutical, CRO, Contract Research Organization

    Skills : Medical Writer

    Medical Writer

    Location : United Kingdom

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