Principal Medical Writer
- Contract Type
TalentSource Life Sciences is currently searching for several experienced Principal Medical Writers to join one of our partner companies - a leading international biopharma - in Raleigh. This is an office based role.
This role 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.
- Write and prepare clinical submissions documents within a team environment, including but not limited to Phase I - III protocols and clinical study reports (CSRs), summary documents (including Integrated Summary of Safety [ISS], Integrated Summary of Efficacy [ISE], Clinical Overview, Clinical Summary), risk management plans, clinical study summaries (for posting to study registries) and clinical parts of Investigational Drug Brochures, agency meeting briefing packages, INDs, IND and EU Annual Safety Updates and responses to agency questions.
- Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) compliant presentation.
- Manage the review and approval process of clinical submission documents; notify team of targeted review responsibilities. 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 Clinical Trial Team, Clinical 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 clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging and style.
- Coordinate with other Clinical Program Medical Writers and other Medical Writers as needed to maintain consistency across documents within a project and across indications.
- Participate in and/or lead 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 outsourced.
- Mentor, coach and/or otherwise assist in the training and development of (Senior) Medical Writers.
- Such other responsibilities and projects as the company may assign.
Experience, Skills, Knowledge
- Bachelor's degree in life science/biological or health related field. Master's or PhD is preferred.
- Extensive experience in regulatory Medical Writing in the pharmaceutical/biopharmaceutical industry.
- Must have submission-level experience (Module 2 document authoring, agency response questions authoring)
- Expert knowledge of medical, pharmaceutical and clinical research concepts
- 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
- Expert knowledge of the methods, techniques and procedures of medical writing tasks
- Prior CSR and Summary Document generation experience, preferably at a sponsor
- Prior experience with submissions in Common Technical Document (CTD) format
- Knowledge of eTechnology related to regulatory submissions activities (eCTD, EDMS, Life Cycle Management)
- Detailed and experience-based understanding of applicable regulations and guidelines (e.g. Code of Federal Regulations, European Directive and International Conference on Harmonisation).
- Strong computer skills: proficiency in MS Word
- Ability to work without close supervision
- Ability to work under stress
- Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines
- Ability to work well within an international team
- Must be detail-orientated, thorough and methodical
- Excellent written and verbal communication skills
- Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
- Excellent problem solving capabilities and organizational skills
- Problem solving
- Can manage uncertainty, shifting priorities and timelines
- 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 judgement to making changes
- Able to adopt an entrepreneurial and innovative style when necessary
Why TalentSource Life Sciences/CROMSOURCE?
CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family 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. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.
Keywords: Medical Writer, MW, Principal Medical Writer, Regulatory Writer, Contract, Freelance, Temporary, CRO, Contract Research Organization, Outsourced, Pharmaceutical, Biopharma
Medical Writer, Medical Writing