Our client is a leading pharmaceutical company and is currently seeking an accomplished Director of Medical Affairs to join the team. Here is an overview of the role:
1) Prepare/co-ordinate and deliver high quality clinical sections of submission (IND/NDA/CTD) and responses to regulatory authorities, and implement medical writing activities
2) Interact with multidisciplinary team members (regulatory, physicians, statisticians, clinicians, data managers and drug safety group) as applicable
3) Discuss the objectives, timelines and documents to be generated, co-ordinate contributions from other groups and do the needed writing and pull together the documents in an efficient, non-disruptive manner for submissions to regulatory authorities
4) Prepare/co-ordinate clinical documents as required (e.g., Clinical Trial Reports (Phase I ? IV) and associated appendices, Investigator's Brochures, Safety Update Reports (PSURs/DSURs, Annual Safety Reports), Ad Hoc Safety Reports, Risk Management Plans, Clinical Expert Statements, Clinical Sections of IND/NDA/CTD)
5) Resolve conflicting comments among reviewers and collate comments for submission to consultants/CRO as necessary
6) Manage the activities of external resources and medical writing vendors (i.e., individual consultant medical writers and contract research organization (CRO) medical writers)
7) Manage projects within pre-defined budget, pre-defined internal resources and time constraints
8) Review medical documents generated outside of MW (e.g., study protocol, statistical analysis plan, tables and listings)
9) Prepare/review SOPs and document templates
10) Track record of developing and mentoring others
More questions? Want to know the Salary range? Keep reading.
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceutical industry is strongly preferred
4) Preference will be given to people have recent experience in medical affairs management
If you are looking to work with a well-established company - one of the top names in the industry - you should not let this opportunity pass by. However, for this Director of Medical Affairs role, you must be someone who is experienced and passionate about medical affairs management.
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.