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Medical Writer
Eingestellt von Synectics
Gesuchte Skills: Mdl
Projektbeschreibung
- Apply analytical skills, functional literacy and expertise in document preparation.
- The author will contribute essential deliverables which could include clinical overviews, integrated analyses of safety and efficacy summaries, responses to regulatory questions, safety updates and regulatory briefing documents.
- Achieved through application of team-working approaches this individual will create and foster an environment of partnership with other members of product teams.
- May also, in collaboration with the Project Team, assess document requirements, complexity, and potential issues with a submission, and develop strategies to deal with these, and lead a team of internal and external (contractors) authors.
PRIMARY RESPONSIBILITIES
- Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and biotherapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products
- For submissions, ensure high quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs.
- Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management.
- Develop and sustain constructive relationships.
- Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents.
- Identify resource, timeline and emerging data interpretation issues that have regulatory impact, and clearly communicate the consequences of these issues to the project team and line management.
- Serve as the point of contact ( go to person) for one or more projects or products.
- Organize and lead a MD Matrix team of authors to deliver all MDL deliverables for each assigned project.
- Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents.
- Manage contract writers, as well as internal writers.
- Able to complete and turn around high quality outputs with only minimal guidance from management.
SKILLS
QUALIFICATIONS
- Scientific/medical academic background (eg, MD, DVM, PhD in relevant field, BSN, PharmD,
- Master's or Bachelors' degree in relevant field), or equivalent.
- Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences.
- Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance.
- Able to clearly articulate scientific and clinical data in all written and verbal communication.
- May include a track record of leadership abilities either as a direct supervisor or within a Matrix
TECHNICAL SKILLS
- Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy.
- Able to think creatively and to develop strategic plans that demonstrate sound judgment.
- Exhibits sound project management and time management skills.
- Able to interact effectively with all levels/roles of project team members.
- Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents.
- Demonstrates proactive nature in taking on assignments and readily mentors other colleagues in area of expertise.Is able to implement systems and processes and suggest process improvements.
- May also include
- Able to project manage and appropriately prioritize medium to high volume of work, with short deadlines
- CTD Modules for NDAs and MAAs: 2.5 clinical overview, 2.7. 1 biopharmaceutics and associated analytical methods, 2.7.2 summary of clinical pharmacology studies, 2.7.3 summary of clinical efficacy, and/or 2.7.4 summary of clinical safety.
- Experience with oncology is also desirable.
- MS Word
- Must have clinical NDA Submission Experience.
Projektdetails
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Einsatzort:
Groton, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung