Medical Writer

Write medical documentation summarizing risks and benefits to assist the development, license application and approval, and post-marketing development drug products.

PRIMARY RESPONSIBILITIES:

- Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and biotherapeutic summaries, regulatory responses, and internal and external risk/benefit briefing documents.
- For submissions, ensure high quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs.
- Author documents such as agency briefing documents, key sections of the Investigator's Brochure, the Annual Safety Report and the core data sheet.
- Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management.
- Develop and sustain constructive relationships within Safety and Regulatory, and with Development Operations, Clinical, Country Offices and other key stakeholders.

ADDITIONAL RESPONSIBILITIES:

- Collaborate with development teams to prepare Clinical/Regulatory documents.
- Identify issues that have regulatory impact, and clearly communicate the consequences of these issues to the project team and management.
- Serve as the point of contact for one or more projects or products.
- Organize and lead a team of authors to deliver all master deliverables lists for each assigned project.
- Ensure consistency of style across different documents.
- Manage contract writers, as well as internal writers.

SKILLS:

TECHNICAL SKILL REQUIREMENTS

- Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy.
- Able to think creatively and to develop strategic plans that demonstrate sound judgment.
- Exhibits sound project management and time management skills.
- Able to interact effectively with all levels/roles of project team members.
- Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents.
- Demonstrates proactive nature in taking on assignments and readily mentors other colleagues in area of expertise.
- Is able to implement systems and processes and suggest process improvements.

ADDITIONAL SKILLS

- Able to project manage and appropriately prioritize medium to high volume of work, with short deadlines.
- Able to complete and turn around high quality outputs with only minimal guidance from management.

QUALIFICATIONS

- Medical writing experience with clinical efficacy and safety summaries in CTD format is critical.
- Ability to think strategically and work collaboratively within project team is required
- Scientific/medical academic background (PharmD/PhD or MSc/BSc), or equivalent experience. BS degree and 1 or more years of pharmaceutical experience preferred.
- Strong functional literacy is desirable (communicating information to scientific and non-scientific audiences).
- Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance.
- Able to clearly articulate scientific and clinical data in all written and verbal communication.
- Previous leadership experience is desired.