Yacht Life Sciences has a vacancy for a Senior Medical Writer who is interested to become a Medical Writing Document Manager Oncology. For the Medical Writing team of our client, we are looking for a Senior Medical Writer who is located with the EU and is willing to work from home.
The responsibilities of the Senior Medical Writer include, but are not limited to the following:
- Works independently to write and edit clinical study reports, Investigator’s Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents across multiple therapeutic areas as assigned. Works with contract writers as needed for the timely delivery of assigned documents.
- Reviews clinical protocols, Statistical Analysis Plans, Statistical Programming Plans, data tables and listings, and other clinical regulatory documents as needed.
- Leads the preparation of briefing documents, INDs, licensing submissions (BLAs, MAAs), and other complex clinical regulatory documents as needed.
- Negotiates timeline development for preparation of clinical regulatory documents.
- Demonstrates critical thinking in the analysis and presentation of clinical study data.
- Leads the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts.
- Provides QC support for clinical regulatory documents as needed (cross-checking data and verifying content from source documents).
- Reviews case report forms, statistical analysis plans, and data tables and listings for content and format.
- Assists with or leads the preparation or revision of SOPs, WPDs, and document templates. Assists with training across functional areas for the implementation of new/revised procedures and templates.
- Participates in clinical project team meetings.
- Participates in or leads other cross-functional team meetings and standards committees.
- Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards.
Once you become a Document Manager, you:
- Act as head of a document working group for multi-component projects with strategic aspects (e.g., marketing applications, Investigational New Drug (IND) applications, responses to regulatory authorities, etc.).
- Coordinate, manage and facilitate the tasks necessary for document drafting, review and completion within a document working group. This may include drafting timelines, requesting quality control (QC) assignments from QC manager, reviewing documents, ensuring timelines are met, etc.
- Act as central point person between the Global Medical Writing Lead (GMWrL) and the document working group.
- Provide intellectual leadership and contributes document knowledge and expertise to the document working group.
- Within assigned therapeutic area, assign fixed and flex writers to projects and ensure new writers are paired with a mentor. Update assignment tracker accordingly.
- Provide mentoring, training and oversight of writers within a therapeutic area to ensure high document quality and low writer turn-around. As required, performs the same tasks as when acting as head of a document working group.
- Act a senior medical writer within assigned therapeutic area.
- Prepare for and conducts interviews with prospective medical writing candidates.
- Participate in meetings to promote quality, efficiencies and value within the program.
- Assist senior staff with metrics.
- Act as line manager to Medical Writers
- Requires an advanced degree in a scientific discipline or a bachelor’s degree with equivalent work experience. MSc or PhD in biological science is highly preferred
- Must have 8+ years project management and writing experience of high-quality clinical and regulatory documents within oncology
- Writing CSRs for pivotal/registration studies or writing clinical sections of licensing submissions is required
- Pharmaceutical industry experience is required
- Fluency in English (both oral and written)
- Background in biologics is a plus
- Excellent writing, editing, verbal and interpersonal communication skills and a strong attention to details.
- Experience writing and editing ICH-compliant clinical regulatory documents according to CTD structure.
- Ability to critically analyze, synthesize, and communicate/present complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
- Ability to adapt and work through conflicts to create consensus.
- Proficiency in Microsoft Office applications.
- Familiarity with CTD, ICH, GCP and other standards.
- Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment.
This is a full-time position (40 hours per week) which can be performed home-based within the EU. This position is open for freelancers as well, but working 40 hours a week is an absolute must.
We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
A multi-national pharmaceutical company providing innovative medicines in areas of health where there is urgent need for better treatments.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.