REMOTE- Pharmaceutical Associate Director of Medical Writing:
Germer International - Pharmaceutical Recruiting

1579679999
Germer International - Pharmaceutical Recruiting
Minneapolis Minnesota
Pharmaceutical
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Description
Our pharmaceutical client, has an opening for a Associate Director of Medical Writing. This organization, one of the fastest growing pharmaceutical organizations on the east coast, is offering opportunities to be a key influencer on the companies next level of growth.

Responsibilities will include:
  • Proactively manages writing activities, planning across assigned projects as appropriate, ensuring adherence to the medical writing strategy and alignment with business needs
  • Readily shares medical writing expertise in support of clinical and regulatory submission documents
  • Supports the timely preparation of scientific manuscripts, conference abstracts, and associated presentations
  • Authors deliverables with consideration for regulatory, corporate, departmental, and quality standards (documents could include but are not limited to protocols, informed consents, clinical study reports, investigator's brochures [IBs], annual reports, Health Authority briefing packages and response documents, submission summary modules, investor presentations and press releases, and standard operating procedures [SOPs])
  • Adheres to medical writing practices/systems/tools to meet company goals and objectives ensuring that standardized practices are implemented and maintained across all supported areas
  • Engages with team members to ensure medical writing continues to deliver value to the business
  • Supports innovation initiatives within the Clinical Development group
Qualifications:
  • 12 years of relevant experience with a BA/BS in Life Science or 8 years of relevant experience with an advanced degree (MS, PhD, MD) in Life Science is required
  • Demonstrated expertise in writing/developing clinical documents in support of global regulatory submissions
  • Ability to interpret and organize scientific and clinical data
  • Medical writing experience in Pharma, Biotech and/or CRO
  • Experience with ICH and electronic submission guidelines for regulatory reports.
  • Experience with publishing techniques a plus