Senior Manager, Nonclinical and Clinical Pharmacology Writing

Proclinical seeking a Senior Manager, Nonclinical and Clinical Pharmacology Writing for a global pharmaceutical company located in Massachusetts.

This position is accountable for the timely development of high quality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio. This position will support operational and regulatory writing activities across the business.

Must be eligible to work in the US.

Job Responsibilities:

• Supporting clinical project teams by authoring and managing the development and completion of high quality NCCP regulatory documents including, but not limited to, Phase 1 clinical study protocols and amendments, Phase 1 clinical study reports, Investigators Brochures, and other IND/CTA or global regulatory submission documents
• Ensuring strategic organization, clarity, accuracy, format, and consistency of scientific content.
• Reviewing and editing documents, or sections of documents, prepared by other medical writers (internal or external), or functional area representatives as required.
• Supporting development and implementation of strategy for writing and completion of high quality NCCP documents.
• Representing MW cross-functionally and with external vendors, negotiating timelines as necessary.
• Participating with other MW team members to develop and implement process and standards and take responsibility for execution in cross functional teams.
• Maintaining adherence to internal guidelines, styles, and processes, standard operating procedures and regulatory requirements in partnership with colleagues from statistical, clinical, nonclinical, regulatory, quality, and patient safety functions.
• Developing effective collaborations with other functional lines within the business, and keeping abreast of regulatory, industry, and medical writing knowledge and best practices.

Skills and Requirements:

• At least 3-5 years of regulatory writing experience, preferably in nonclinical and clinical pharmacology.
• Will consider fewer years of writing experience combined with other relevant pharmaceutical industry or research experience.
• Demonstrated capability to understand and summarize complex NCCP data, and write and manage NCCP regulatory documents, in particular Investigators Brochures, Phase 1 clinical protocols, and clinical study reports.
• Demonstrated capability to understand global clinical trial regulations and processes.
• Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.
• Skilled at project management, with emphasis on time management, organization, and negotiation.
• Excellent oral, written, and presentation skills; advanced user of MS Office suite.
• Results and compliance driven; sets standard of excellence for self and others.
• MS or PhD degree in life sciences, preferably pharmacology, or advanced degree in a relevant scientific/clinical/regulatory field.
• Proven experience with global clinical studies.
• Ability to establish excellent internal and external relationships, including alliance partners and vendors.
• Team player who thrives in a team-based environment.
• Well-developed sense of ethics, responsibility, and respect for others.
• Agile learner with ability to work both collaboratively and independently, seeking advice as required.
• High level of flexibility and ability to innovate and adapt

If you are having difficulty in applying or if you have any questions, please contact Patrick Mooney at +(1) 619-963-2702 or p.mooney@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.

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