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Director, Medical Writing

Status: Active
CompanyRVAC Medicines
LocationBoston, MA
Expiration2023-06-14
How to Apply

Please send you resume to CareerDevelopment@rvacmed.com

Responsibilities:

1. Independently authors complex documents compliant with relevant internal processes and standards as well as external regulatory guidance.

2. Provides strategic and operational leadership to direct preparation and completion of documents. Collaborates with project teams, subject matter experts, and quality lines to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. 

3. Communicates Medical Writing’s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.

4. If assigned by manager, serves as the Medical Writing ‘point of contact’ for all document issues for a given asset or set of assets.

5. Produces documents in conjunction with vendors. Reviews documents produced by vendors and helps evaluate vendor performance.

Qualifications:

1. Bachelor’s degree, preferably in a life science discipline.

2. BS/BA +12 years, MS/MA +10 years, PhD +7 years of experience in medical writing or related field.

3. Ability to manage documents of greater complexity and/or variety.

4. Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.

5. Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.

6. Contributes to improvements in templates, procedures, job aids, and onboarding and training materials for function.

7. Engages in continuous learning; shows commitment to being familiar with new regulations and industry standards, new technology, and new processes that impact Medical Writing.

8. Comprehensive understanding of the drug development process and how medical writing documents support development at different stages.

9. Knowledge of how to use publicly available databases (eg, PubMed, DailyMed, FDA, and EMA sources and guidelines) for literature and information mining to support document content and how to cite such information appropriately.

10. Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel).

11. Advanced degree (MS/MA/PhD) is preferred.

12. A minimum of 5 years in Medical Writing with experience of marketing application submissions (NDAs and MAAs, associated pivotal CSRs) is preferred.

13. Prior experience with document management systems and collaboration software (including cloud-based systems) and co-authoring principles is preferred.

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