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Principal Medical Writer

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support

Projektbeschreibung

One of the world's largest pharmaceutical companies is hiring for a Principal Medical Writer to manage the submission documentation processes and personnel for INDs,MAAs, BLAs and NDAs. The salary range is up to $135k depending on experience level. Top tier relocation package is offered with house buyout assistance, closing cost coverage, personal real estate broker service, temporary housing coverage and much more! Responsibilities: -Drive development and manage implementation of regulatory documentation strategy to meet time and quality performance goals for filing regulatory dossiers as planned by development teams -Write key documents such as ISS, ISE, clinical overviews, and summaries and lead submission efforts by managing the strategies and best practices -Coordinate medical writing activities of all inter-disciplinary groups such as clinical and life-cycle management -Ensure documentation strategy is integrated to support regulatory commitments across preclinical and clinical areas -Critically review project-specific model documents, key data texts and displays during dossier prototype creation and facilitate reaching a consensus at key findings/final document review meetings -Influence assigned development teams in tracking milestone activities and proactively identify any issues -Manage and mentor junior writers, possibility of direct reports tbd Requirements: -PhD/MD/PharmD in relevant discipline or MS/BS degree in science-related field -Medical writing experience of over 7 years with management experience of at least 1 direct report -Lead regulatory submission experience REQUIRED for at least 1 year -Experience of managing timelines and quality of work using strong organizational and communication skills This company has excellent bonus structure, equity plans, and top tier relocation packages available. The medical writing team is very robust, with low turnover rates, and management is easily accessible, working closely with every member of the team. If you're ready for career progression, stability, growth and being a valued member of a close-knit team, send your resume to Dandan Zhu at Real Pharma at 212-707-8499.

To find out more about Real please visit www.realstaffing.com [1]

Links:
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[1] http://www.realstaffing.com

Projektdetails

  • Einsatzort:

    Boston, Massachusetts, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland