Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Medical Writer

Eingestellt von Synectics

Gesuchte Skills: Support, Marketing

Projektbeschreibung

RESPONSIBILITIES:

- Provide medical documentation summarizing risks and benefits in support of the development, license application and approval, and post-marketing development of one or more drug products.
- Applying analytical skills, functional literacy and expertise in document preparation.
- Contribute essential deliverables which could include clinical overviews, integrated analyses of safety and efficacy, responses to regulatory questions, risk management plans, key sections of the Investigator's Brochure, the Annual Safety Report and regulatory briefing documents.
- Create and foster an environment of partnership with other members of product teams.
- 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.
- 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 components that are compliant with regulations, guidelines, and corporate SOPs.
- Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management.
- 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.
- 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.

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. Able to project manage and appropriately prioritize medium to high volume of work, with short deadlines. Able to complete and turn around high quality outputs with only minimal guidance from management. Scientific/medical academic background (eg PharmD/PhD or MSc/BSc with experience), or equivalent. 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 setting. 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 non-scientific audiences. MS Outlook, MS Word experience desired.

Synectics is an Equal Opportunity Employer.

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Synectics