Sr/Director of Medical Writing - Permanent - Remote within US

Proclinical is seeking a Senior Director/Director for Medical Writing.

Primary Responsibilities:

This role is perfect for an expert medical writer who is adept at planning, developing, and writing clinical documents to support medical and regulatory activities across various portfolios. The role requires a strategic thinker who can guide teams and drive initiatives.

Skills & Requirements:

• PhD in life sciences, it is preferred that this is in biological science.
• Extensive experience in medical and/or scientific writing, preferably within the pharmaceutical industry.
• Knowledge and experience in Oncology and Immunology would be advantageous.
• Extensive experience with clinical documents and regulatory filings (NDA, BLA, MAA).
• Expert knowledge of regulatory requirements, drug development processes, and clinical study data reporting.
• Collaborative with strong leadership and interpersonal skills.

The Sr/Director of Medical Writing's responsibilities will be:

• Lead the planning and authoring of complex clinical and regulatory documents.
• Guide medical writing and project teams during the planning and authoring stages.
• Drive strategic medical writing initiatives and ensure execution on company priorities.
• Lead the development and improvement of departmental processes, policies, SOPs, training, and work guidance.
• Mentor junior writers and contribute to departmental strategy and objectives.

If you are having difficulty in applying or if you have any questions, please contact Evelyn Li at e.li@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.