Germer International Hiring for Pharmaceutical- Associate Director of Medical Writer Job at Remote Full Time

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

Job Type: Full-time

Pay: $150,000.00 – $175,000.00 per year

Schedule:

• Monday to Friday

Education:

• Bachelor’s (Preferred)

Work Location: Remote