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